[xls] · web viewcalcium ascorbate dihydrate (hplc) fatty acids chromatographic profile d-alpha...

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005387ALS Pharmaceutical Method Index NSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500) VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111) E: [email protected] 005387Updated on: 08-July-2015 005387Page 1 of 152 Please search the list below for your desired analyte. Note: The list is not exhaustive and monographs are added regularly Raw Material Monographs ALS Pharmaceutical cannot perform Monograph Name Test Number ANALYTE ACS Acetic Anhydride 1 Assay ACS Acetic Anhydride 2 Residue after evaporation ACS Acetic Anhydride 3 Chloride ACS Acetic Anhydride 4 Phosphate ACS Acetic Anhydride 5 Sulfate ACS Acetonitrile 1 Appearance ACS Acetonitrile 2 Assay ACS Acetonitrile 3 Color ACS Acetonitrile 4 Residue after evaporation ACS Acetonitrile 5 Titrable acid ACS Acetonitrile 6 Titrable Base ACS Acetonitrile 7 Water ACS Ammonium Nitrate 1 Assay ACS Ammonium Nitrate 2 pH (25 °C) ACS Ammonium Nitrate 3 Insoluble Matter ACS Ammonium Nitrate 4 Residue after ignition ACS Ammonium Nitrate 5 Chloride ACS Ammonium Nitrate 6 Nitrite ACS Ammonium Nitrate 7 Phosphate ACS Ammonium Nitrate 8 Sulfate ACS Ammonium Nitrate 9 Heavy Metals ACS Ammonium Nitrate 10 Iron ACS Ethyl Alcohol 1 Assay ACS Ethyl Alcohol 2 Color ACS Ethyl Alcohol 3 Titrable acid ACS Ethyl Alcohol 4 Limit of Acetone & Isopropyl alcohol ACS Molybdenum Trioxide 1 Appearance ACS Molybdenum Trioxide 2 Solubility ACS Molybdenum Trioxide 3 Melting point ACS Molybdenum Trioxide 4 Assay ACS Molybdenum Trioxide 5 Ammonia Insoluble Matter ACS Molybdenum Trioxide 6 Chloride ACS Molybdenum Trioxide 7 Nitrate ACS Molybdenum Trioxide 8 Arsenate, Phosphate and silicate (as SiO2) ACS Molybdenum Trioxide 9 Phosphate ACS Molybdenum Trioxide 10 Sulfate ACS Molybdenum Trioxide 11 Ammonium ACS Molybdenum Trioxide 12 Heavy Metals (as Pb) ACS Potassium Oxalate Monohydrate 1 Assay ACS Potassium Oxalate Monohydrate 2 Substances darkened by hot sulfuric acid ACS Potassium Oxalate Monohydrate 3 Neutrality ACS Potassium Oxalate Monohydrate 4 Insoluble Matter ACS Potassium Oxalate Monohydrate 5 Chloride ACS Potassium Oxalate Monohydrate 6 Ammonium ACS Potassium Oxalate Monohydrate 7 Heavy Metals ACS Potassium Oxalate Monohydrate 8 Iron ACS Pyridine 1 Appearance ACS Pyridine 2 Boiling Point ACS Pyridine 4 Residue after evaporation ACS Pyridine 5 Water ACS Pyridine 6 Chloride ACS Pyridine 7 Sulfate ACS Pyridine 8 Ammonia ACS Pyridine (Assay) 3 Assay ACS Tetrahydrofuran 1 Appearance ACS Tetrahydrofuran 2 Assay ACS Tetrahydrofuran 3 Color ACS Tetrahydrofuran 4 Peroxide (as H2O2) ACS Tetrahydrofuran 5 Residue after evaporation ACS Tetrahydrofuran 6 Water If you cannot find what you need please email us and we may be able to help

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Page 1: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 1 of 181

Please search the list below for your desired analyte.Note: The list is not exhaustive and monographs are added regularly

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTEACS Acetic Anhydride 1 AssayACS Acetic Anhydride 2 Residue after evaporationACS Acetic Anhydride 3 ChlorideACS Acetic Anhydride 4 PhosphateACS Acetic Anhydride 5 SulfateACS Acetonitrile 1 AppearanceACS Acetonitrile 2 AssayACS Acetonitrile 3 ColorACS Acetonitrile 4 Residue after evaporationACS Acetonitrile 5 Titrable acidACS Acetonitrile 6 Titrable BaseACS Acetonitrile 7 WaterACS Ammonium Nitrate 1 AssayACS Ammonium Nitrate 2 pH (25 °C)ACS Ammonium Nitrate 3 Insoluble MatterACS Ammonium Nitrate 4 Residue after ignitionACS Ammonium Nitrate 5 ChlorideACS Ammonium Nitrate 6 NitriteACS Ammonium Nitrate 7 PhosphateACS Ammonium Nitrate 8 SulfateACS Ammonium Nitrate 9 Heavy MetalsACS Ammonium Nitrate 10 IronACS Ethyl Alcohol 1 AssayACS Ethyl Alcohol 2 ColorACS Ethyl Alcohol 3 Titrable acidACS Ethyl Alcohol 4 Limit of Acetone & Isopropyl alcoholACS Molybdenum Trioxide 1 AppearanceACS Molybdenum Trioxide 2 SolubilityACS Molybdenum Trioxide 3 Melting pointACS Molybdenum Trioxide 4 AssayACS Molybdenum Trioxide 5 Ammonia Insoluble MatterACS Molybdenum Trioxide 6 ChlorideACS Molybdenum Trioxide 7 NitrateACS Molybdenum Trioxide 8ACS Molybdenum Trioxide 9 PhosphateACS Molybdenum Trioxide 10 SulfateACS Molybdenum Trioxide 11 AmmoniumACS Molybdenum Trioxide 12 Heavy Metals (as Pb)ACS Potassium Oxalate Monohydrate 1 AssayACS Potassium Oxalate Monohydrate 2 Substances darkened by hot sulfuric acidACS Potassium Oxalate Monohydrate 3 NeutralityACS Potassium Oxalate Monohydrate 4 Insoluble MatterACS Potassium Oxalate Monohydrate 5 ChlorideACS Potassium Oxalate Monohydrate 6 AmmoniumACS Potassium Oxalate Monohydrate 7 Heavy MetalsACS Potassium Oxalate Monohydrate 8 IronACS Pyridine 1 AppearanceACS Pyridine 2 Boiling PointACS Pyridine 4 Residue after evaporation

If you cannot find what you need please email us and we may be able to help

Test Number

Arsenate, Phosphate and silicate (as SiO2)

Page 2: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 2 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberACS Pyridine 5 Water

ACS Pyridine 6 ChlorideACS Pyridine 7 SulfateACS Pyridine 8 AmmoniaACS Pyridine (Assay) 3 AssayACS Tetrahydrofuran 1 AppearanceACS Tetrahydrofuran 2 AssayACS Tetrahydrofuran 3 ColorACS Tetrahydrofuran 4 Peroxide (as H2O2)ACS Tetrahydrofuran 5 Residue after evaporationACS Tetrahydrofuran 6 WaterBP (-)-a- Bisabolol AppearanceBP (S)-Lactic Acid 1 AppearanceBP (S)-Lactic Acid 2 SolubilityBP (S)-Lactic Acid 3 Identification ABP (S)-Lactic Acid 4 Identification BBP (S)-Lactic Acid 5 Identification CBP (S)-Lactic Acid 6 Identification DBP (S)-Lactic Acid 7 Appearance (Test)BP (S)-Lactic Acid 8 Ether - Insoluble substancesBP (S)-Lactic Acid 9 Sugars and other reducing substancesBP (S)-Lactic Acid 10 Methanol (Residual Solvents)BP (S)-Lactic Acid 11 Citic, oxalic and phosphoric acidsBP (S)-Lactic Acid 12 SulfatesBP (S)-Lactic Acid 13 CalciumBP (S)-Lactic Acid 14 Heavy MetalsBP (S)-Lactic Acid 15 Sulfated AshBP (S)-Lactic Acid 16 AssayBP (S)-Lactic Acid 17 (S)-enantiomerBP Acepromazine Injection 1 Identification ABP Acepromazine Injection 2 Identification BBP Acepromazine Injection 3 Identification CBP Acepromazine Injection 4 Identification DBP Acepromazine Injection 5 Acidity (pH)BP Acepromazine Injection 6 AssayBP Acepromazine Maleate 1 CharacteristicsBP Acepromazine Maleate 2 Identification ABP Acepromazine Maleate 3 Identification BBP Acepromazine Maleate 4 Identification CBP Acepromazine Maleate 5 AcidityBP Acepromazine Maleate 6 Melting pointBP Acepromazine Maleate 7 Related SubstancesBP Acepromazine Maleate 8 Loss on DryingBP Acepromazine Maleate 9 Sulfated AshBP Acepromazine Maleate 10 Assay (dried substance)BP Acesulfame Potassium 1 AppearanceBP Acesulfame Potassium 2 SolubilityBP Acesulfame Potassium 3 Identification ABP Acesulfame Potassium 4 Identification BBP Acesulfame Potassium 6 Appearance of solutionBP Acesulfame Potassium 7 Acidity or alkalinityBP Acesulfame Potassium 8 Impurity A

Page 3: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 3 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Acesulfame Potassium 10 Fluorides

BP Acesulfame Potassium 11 Heavy MetalsBP Acesulfame Potassium 12 Loss on dryingBP Acesulfame Potassium 13 Assay

9 Impurity B

9 Related Substances

9 Total

9 unspecified impuritiesBP Acetone 1 AppearanceBP Acetone 2 SolubilityBP Acetone 3 Identification ABP Acetone 4 Identification BBP Acetone 5 Identification CBP Acetone 6 Appearance of solutionBP Acetone 7 Acidity or alkalinityBP Acetone 8 Relative densityBP Acetone 9 Reducing SubstancesBP Acetone 11 Matter Insoluble in WaterBP Acetone 12 Residue on evaporationBP Acetone 13 WaterBP Acetone (Related substances) 10 Related SubstancesBP Acetone (Related substances) 10 Impurities A, BBP Acetone (Related substances) 10 Any other impurityBP Acetone (Related substances) 10 Impurity CBP Acid Value Acid ValueBP Acid Value Free fatty acidsBP Activated Charcoal 1 AppearanceBP Activated Charcoal 2 SolubilityBP Activated Charcoal 3 Identification ABP Activated Charcoal 4 Identification BBP Activated Charcoal 5 Acidity or alkalinityBP Activated Charcoal 6 Acid-soluble substancesBP Activated Charcoal 7 Alkali-soluble coloured substancesBP Activated Charcoal 8 Ethanol (96%) soluble substancesBP Activated Charcoal 9 Fluorescent substancesBP Activated Charcoal 10 SulfidesBP Activated Charcoal 11 Loss on dryingBP Activated Charcoal 12 Sulfated AshBP Activated Charcoal 13 Adsorption powerBP Adrenaline Acid Tartrate 1 AppearanceBP Adrenaline Acid Tartrate 2 SolubilityBP Adrenaline Acid Tartrate 3 Identification ABP Adrenaline Acid Tartrate 4 Identification BBP Adrenaline Acid Tartrate 5 Identification CBP Adrenaline Acid Tartrate 6 Appearance of SolutionBP Adrenaline Acid Tartrate 7 Related SubstancesBP Adrenaline Acid Tartrate 7 Impurities B, CBP Adrenaline Acid Tartrate 7 Impurities D, EBP Adrenaline Acid Tartrate 7 Total impurities

BP Acesulfame Potassium (Related substances)BP Acesulfame Potassium (Related substances)BP Acesulfame Potassium (Related substances)BP Acesulfame Potassium (Related substances)

Page 4: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 4 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Adrenaline Acid Tartrate 7 Disregard limit

BP Adrenaline Acid Tartrate 8 Loss on DryingBP Adrenaline Acid Tartrate 9 Sulfated AshBP Adrenaline Acid Tartrate 10 AssayBP Alanine 1 CharactersBP Alanine 2 Identification ABP Alanine 3 Identification BBP Alanine 4 Identification CBP Alanine 5 Identification DBP Alanine 6 Appearance of SolutionBP Alanine 7 Specific Optical RotationBP Alanine 8 Ninhydrin Positive SubstancesBP Alanine 9 ChloridesBP Alanine 10 SulfatesBP Alanine 11 AmmoniaBP Alanine 12 IronBP Alanine 13 Heavy MetalsBP Alanine 14 Loss on DryingBP Alanine 15 Sulfated AshBP Alanine 16 AssayBP Albendazole 1 AppearanceBP Albendazole 2 SolubilityBP Albendazole 3 Identification by Infrared AbsorptionBP Albendazole 4 Appearance of solutionBP Albendazole 5 Related SubstancesBP Albendazole 5 Impurity ABP Albendazole 5 Impurity BBP Albendazole 5 Impurity CBP Albendazole 5 Impurity DBP Albendazole 5 Impurity EBP Albendazole 5 Impurity FBP Albendazole 5 TotalBP Albendazole 6 Loss on DryingBP Albendazole 7 Sulfated AshBP Albendazole 8 AssayBP Alfaxalone 1 CharacteristicsBP Alfaxalone 2 Identification ABP Alfaxalone 3 Identification BBP Alfaxalone 4 Identification CBP Alfaxalone 5 Light AbsorptionBP Alfaxalone 6 Related SubstancesBP Alfaxalone 7 Loss on DryingBP Alfaxalone 8 Sulfated AshBP Alfaxalone 9 AssayBP Allantoin 1 Appearance BP Allantoin 2 SolubilityBP Allantoin 3 Melting PointBP Allantoin 4 Identification ABP Allantoin 5 Identification BBP Allantoin 6 Identification CBP Allantoin 7 Identification DBP Allantoin 8 Acidity or Alkalinity

Page 5: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 5 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Allantoin 9 Optical rotation

BP Allantoin 10 Reducing SubstancesBP Allantoin 11 Related SubstancesBP Allantoin 12 Loss on DryingBP Allantoin 13 Sulfated AshBP Allantoin 14 AssayBP all-rac-Alpha-Tocopherol 1 AppearanceBP all-rac-Alpha-Tocopherol 2 SolubilityBP all-rac-Alpha-Tocopherol 3 Identification ABP all-rac-Alpha-Tocopherol 4 Identification BBP all-rac-Alpha-Tocopherol 5 Identification C

6 Related Substances

6 Disregard limit

6 sum of impurities C and D

6 Impurity A

6 Impurity B

6 Any other impurity

6 Total

7 AssayBP all-rac-Alpha-Tocopheryl Acetate 1 AppearanceBP all-rac-Alpha-Tocopheryl Acetate 2 SolubilityBP all-rac-Alpha-Tocopheryl Acetate 3 Identification ABP all-rac-Alpha-Tocopheryl Acetate 4 Identification BBP all-rac-Alpha-Tocopheryl Acetate 5 Identification C

6 Related Substances

6 Impurity A, C

6 Impurity B

6 Disregard limit

6 Any other impurity

6 Sum of impurities D and E

6 Total

7 Assay

1 Appearance

2 Solubility

3 Identification A

BP all-rac-Alpha-Tocopherol (Assay and/or Related substances)BP all-rac-Alpha-Tocopherol (Assay and/or Related substances)BP all-rac-Alpha-Tocopherol (Assay and/or Related substances)BP all-rac-Alpha-Tocopherol (Assay and/or Related substances)BP all-rac-Alpha-Tocopherol (Assay and/or Related substances)BP all-rac-Alpha-Tocopherol (Assay and/or Related substances)BP all-rac-Alpha-Tocopherol (Assay and/or Related substances)BP all-rac-Alpha-Tocopherol (Assay and/or Related substances)

BP all-rac-Alpha-Tocopheryl Acetate (Assay and/or Related substances)BP all-rac-Alpha-Tocopheryl Acetate (Assay and/or Related substances)BP all-rac-Alpha-Tocopheryl Acetate (Assay and/or Related substances)BP all-rac-Alpha-Tocopheryl Acetate (Assay and/or Related substances)BP all-rac-Alpha-Tocopheryl Acetate (Assay and/or Related substances)BP all-rac-Alpha-Tocopheryl Acetate (Assay and/or Related substances)BP all-rac-Alpha-Tocopheryl Acetate (Assay and/or Related substances)BP all-rac-Alpha-Tocopheryl Acetate (Assay and/or Related substances)BP Alpha Tocopheryl Acetate Concentrate (Powder Form)BP Alpha Tocopheryl Acetate Concentrate (Powder Form)BP Alpha Tocopheryl Acetate Concentrate (Powder Form)

Page 6: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 6 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

4 Identification B

5 AssayBP Alpha Tocopheryl Hydrogen succinate 1 AppearanceBP Alpha Tocopheryl Hydrogen succinate 2 SolubilityBP Alpha Tocopheryl Hydrogen succinate 3 Identification ABP Alpha Tocopheryl Hydrogen succinate 4 Identification BBP Alpha Tocopheryl Hydrogen succinate 5 Identification CBP Alpha Tocopheryl Hydrogen succinate 6 Identification DBP Alpha Tocopheryl Hydrogen succinate 7 Optical rotationBP Alpha Tocopheryl Hydrogen succinate 8 AbsorbanceBP Alpha Tocopheryl Hydrogen succinate 9 Acid ValueBP Alpha Tocopheryl Hydrogen succinate 10 Free TocopherolBP Alpha Tocopheryl Hydrogen succinate 11 Heavy MetalsBP Alpha Tocopheryl Hydrogen succinate 12 Sulfated AshBP Alpha Tocopheryl Hydrogen succinate 13 AssayBP Aluminium Hydroxide Oral Suspension 1 CharacteristicsBP Aluminium Hydroxide Oral Suspension 2 IdentificationBP Aluminium Hydroxide Oral Suspension 3 AlkalinityBP Aluminium Hydroxide Oral Suspension 4 Neutralising capacityBP Aluminium Hydroxide Oral Suspension 5 Ammonium saltsBP Aluminium Hydroxide Oral Suspension 6 Heavy MetalsBP Aluminium Hydroxide Oral Suspension 7 ChlorideBP Aluminium Hydroxide Oral Suspension 8 SulfateBP Aluminium Hydroxide Oral Suspension 9 AssayBP Aluminium Magnesium Silicate 1 AppearanceBP Aluminium Magnesium Silicate 2 SolubilityBP Aluminium Magnesium Silicate 3 Identification ABP Aluminium Magnesium Silicate 4 Identification BBP Aluminium Magnesium Silicate 5 Identification CBP Aluminium Magnesium Silicate 6 pHBP Aluminium Magnesium Silicate 7 Loss on dryingBP Ammonium Bicarbonate 1 AppearanceBP Ammonium Bicarbonate 2 SolubilityBP Ammonium Bicarbonate 3 Identification ABP Ammonium Bicarbonate 4 Identification BBP Ammonium Bicarbonate 5 ChloridesBP Ammonium Bicarbonate 6 SulfatesBP Ammonium Bicarbonate 7 IronBP Ammonium Bicarbonate 8 Heavy MetalsBP Ammonium Bicarbonate 9 AssayBP Ammonium Chloride 1 AppearanceBP Ammonium Chloride 2 SolubilityBP Ammonium Chloride 3 Identification ABP Ammonium Chloride 4 Identification BBP Ammonium Chloride 5 Appearance of solutionBP Ammonium Chloride 6 Acidity or alkalinityBP Ammonium Chloride 7 Bromides and iodidesBP Ammonium Chloride 8 SulfatesBP Ammonium Chloride 9 CalciumBP Ammonium Chloride 10 IronBP Ammonium Chloride 11 Heavy Metals

BP Alpha Tocopheryl Acetate Concentrate (Powder Form) (ID B and/or Assay)BP Alpha Tocopheryl Acetate Concentrate (Powder Form) (ID B and/or Assay)

Page 7: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 7 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Ammonium Chloride 12 Loss on drying

BP Ammonium Chloride 13 Sulfated AshBP Ammonium Chloride 14 AssayBP Amoxicillin Trihydrate 1 AppearanceBP Amoxicillin Trihydrate 2 SolubilityBP Amoxicillin Trihydrate 3 Identification ABP Amoxicillin Trihydrate 4 Identification BBP Amoxicillin Trihydrate 5 Identification CBP Amoxicillin Trihydrate 6 pHBP Amoxicillin Trihydrate 7 Specific Optical RotationBP Amoxicillin Trihydrate 10 WaterBP Amoxicillin Trihydrate 11 Sulfated Ash

8 Related Substances

8 Any impurity

12 Assay

9 N,N-DimethylanilineBP Anhydrous Citric Acid 1 AppearanceBP Anhydrous Citric Acid 2 SolubilityBP Anhydrous Citric Acid 3 Melting pointBP Anhydrous Citric Acid 4 Identification ABP Anhydrous Citric Acid 5 Identification BBP Anhydrous Citric Acid 6 Identification CBP Anhydrous Citric Acid 7 Identification DBP Anhydrous Citric Acid 8 Identification EBP Anhydrous Citric Acid 9 Appearance of solutionBP Anhydrous Citric Acid 10 Readily carbonisable substancesBP Anhydrous Citric Acid 11 Oxalic acidBP Anhydrous Citric Acid 12 SulfatesBP Anhydrous Citric Acid 13 WaterBP Anhydrous Citric Acid 14 Heavy MetalsBP Anhydrous Citric Acid 15 AluminiumBP Anhydrous Citric Acid 16 Sulfated AshBP Anhydrous Citric Acid 17 Assay

1 Appearance

2 Solubility

3 Identification A

4 Identification B

5 Identification C

6 Identification D

7 Appearance of solution

8 Reducing Substances

BP Amoxicillin Trihydrate (Assay and/or Related substances)BP Amoxicillin Trihydrate (Assay and/or Related substances)BP Amoxicillin Trihydrate (Assay and/or Related substances)BP Amoxicillin Trihydrate (N,N-Dimethylaniline)

BP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen Phosphate

Page 8: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 8 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

9 Monosodium phosphate

10 Chlorides

11 Sulfates

12 Arsenic

13 Iron

14 Heavy Metals

15 Loss on drying

16 AssayBP Anhydrous Magnesium Citrate 1 AppearanceBP Anhydrous Magnesium Citrate 2 SolubilityBP Anhydrous Magnesium Citrate 3 Identification ABP Anhydrous Magnesium Citrate 4 Identification BBP Anhydrous Magnesium Citrate 5 Identification CBP Anhydrous Magnesium Citrate 6 Identification DBP Anhydrous Magnesium Citrate 7 Appearance of solutionBP Anhydrous Magnesium Citrate 8 pHBP Anhydrous Magnesium Citrate 9 OxalatesBP Anhydrous Magnesium Citrate 10 SulfatesBP Anhydrous Magnesium Citrate 11 CalciumBP Anhydrous Magnesium Citrate 12 IronBP Anhydrous Magnesium Citrate 13 Heavy MetalsBP Anhydrous Magnesium Citrate 14 Loss on dryingBP Anhydrous Magnesium Citrate 15 AssayBP Anhydrous Sodium Sulfate 1 AppearanceBP Anhydrous Sodium Sulfate 2 SolubilityBP Anhydrous Sodium Sulfate 3 Identification ABP Anhydrous Sodium Sulfate 4 Identification BBP Anhydrous Sodium Sulfate 5 Identification CBP Anhydrous Sodium Sulfate 6 Appearance of solutionBP Anhydrous Sodium Sulfate 7 Acidity or alkalinityBP Anhydrous Sodium Sulfate 8 ChloridesBP Anhydrous Sodium Sulfate 9 CalciumBP Anhydrous Sodium Sulfate 10 IronBP Anhydrous Sodium Sulfate 11 MagnesiumBP Anhydrous Sodium Sulfate 12 Heavy MetalsBP Anhydrous Sodium Sulfate 13 Loss on dryingBP Anhydrous Sodium Sulfate 14 AssayBP Anhydrous Sodium Sulfite 1 AppearanceBP Anhydrous Sodium Sulfite 2 SolubilityBP Anhydrous Sodium Sulfite 3 Identification ABP Anhydrous Sodium Sulfite 3 Identification BBP Anhydrous Sodium Sulfite 4 Identification CBP Anhydrous Sodium Sulfite 5 Identification DBP Anhydrous Sodium Sulfite 6 Appearance of solutionBP Anhydrous Sodium Sulfite 7 Thiosulfates

BP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen PhosphateBP Anhydrous Disodium Hydrogen Phosphate

Page 9: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 9 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Anhydrous Sodium Sulfite 8 Iron

BP Anhydrous Sodium Sulfite 9 SeleniumBP Anhydrous Sodium Sulfite 10 Heavy MetalsBP Anhydrous Sodium Sulfite 11 AssayBP Anise Oil 1 AppearanceBP Anise Oil 2 Identification ABP Anise Oil 4 Relative densityBP Anise Oil 5 Refractive indexBP Anise Oil 6 Freezing PointBP Anise Oil 9 Fatty oils and resinified essential oils

3 Identification B

7 Fenchone

8 Foeniculin

10 Chromatographic Profile

10 Anisaldehyde

10 Pseudoisoeugenyl 2-methylbutyrate

10 trans-Anethole

10 cis-Anethole

10 alpha-Terpineol

10 Linalol

10 EstragoleBP Anisidine value 1 Anisidine ValueBP Aqueous Iodine Oral Solution 1 Content of iodine, IBP Aqueous Iodine Oral Solution 2 Content of potassium iodide, KIBP Arachis Oil 1 AppearanceBP Arachis Oil 2 SolubilityBP Arachis Oil 3 Relative DensityBP Arachis Oil 4 Identification (TLC)BP Arachis Oil 5 Acid Value BP Arachis Oil 6 Peroxide ValueBP Arachis Oil 7 Unsaponifiable MatterBP Arachis Oil 8 Alkaline ImpuritiesBP Arachis Oil 9 Composition of Fatty AcidsBP Arachis Oil 9BP Arachis Oil 9 Palmitic AcidBP Arachis Oil 9 Stearic Acid BP Arachis Oil 9 Oleic AcidBP Arachis Oil 9 Linoleic AcidBP Arachis Oil 9 Linolenic AcidBP Arachis Oil 9 Arachidic AcidBP Arachis Oil 9 Eicosenoic Acid

BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)BP Anise Oil (ID B and/or Chromatographic profile)

Saturated Fatty Acids of chain length less than C:16

Page 10: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 10 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Arachis Oil 9 Behenic Acid

BP Arachis Oil 9 Erucic AcidBP Arachis Oil 9 Lignoceric AcidBP Arachis Oil 10 WaterBP Arachis Oil AppearanceBP Arginine 1 CharactersBP Arginine 2 Identification ABP Arginine 3 Identification BBP Arginine 4 Identification CBP Arginine 5 Identification DBP Arginine 6 Identification EBP Arginine 7 Appearance of solutionBP Arginine 8 Specific Optical RotationBP Arginine 9 Ninhydrin-positive substancesBP Arginine 10 ChloridesBP Arginine 11 SulfatesBP Arginine 12 AmmoniumBP Arginine 13 IronBP Arginine 14 Heavy MetalsBP Arginine 15 Loss on DryingBP Arginine 16 Sulfated AshBP Arginine 17 AssayBP Arginine Hydrochloride 1 CharactersBP Arginine Hydrochloride 2 Identification ABP Arginine Hydrochloride 3 Identification BBP Arginine Hydrochloride 4 Identification CBP Arginine Hydrochloride 5 Identification DBP Arginine Hydrochloride 6 Identification EBP Arginine Hydrochloride 7 Appearance of solutionBP Arginine Hydrochloride 8 Specific Optical RotationBP Arginine Hydrochloride 9 Ninhydrin-positive substancesBP Arginine Hydrochloride 10 SulfatesBP Arginine Hydrochloride 10 AmmoniumBP Arginine Hydrochloride 11 IronBP Arginine Hydrochloride 12 Heavy MetalsBP Arginine Hydrochloride 13 Loss on DryingBP Arginine Hydrochloride 14 Sulfated AshBP Arginine Hydrochloride 15 Assay (Dried substance)

1 Identification A

2 Identification B

3 Identification C

4 Acidity

5 Ninhydrin Positive Substances

6 AssayBP Arnica Tincture 1 AppearanceBP Arnica Tincture 2 IdentificationBP Arnica Tincture 5 Dry residue

BP Arginine Hydrochloride Intravenous InfusionBP Arginine Hydrochloride Intravenous InfusionBP Arginine Hydrochloride Intravenous InfusionBP Arginine Hydrochloride Intravenous InfusionBP Arginine Hydrochloride Intravenous InfusionBP Arginine Hydrochloride Intravenous Infusion

Page 11: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 11 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

3 Ethanol

4 Methanol and 2-propanolBP Ascorbic Acid 1 AppearanceBP Ascorbic Acid 2 SolubilityBP Ascorbic Acid 3 Melting pointBP Ascorbic Acid 4 Identification ABP Ascorbic Acid 5 Identification BBP Ascorbic Acid 6 Identification CBP Ascorbic Acid 7 Identification DBP Ascorbic Acid 8 Appearance of solutionBP Ascorbic Acid 9 Specific Optical RotationBP Ascorbic Acid 10 Impurity EBP Ascorbic Acid 12 Copper (by ICP)BP Ascorbic Acid 13 IronBP Ascorbic Acid 14 Heavy MetalsBP Ascorbic Acid 15 Sulfated AshBP Ascorbic Acid 16 AssayBP Ascorbic Acid (Related substances) 11 Related SubstancesBP Ascorbyl Palmitate 1 AppearanceBP Ascorbyl Palmitate 2 SolubilityBP Ascorbyl Palmitate 3 Identification ABP Ascorbyl Palmitate 4 Identification BBP Ascorbyl Palmitate 5 Identification CBP Ascorbyl Palmitate 6 Appearance of solutionBP Ascorbyl Palmitate 7 Specific Optical RotationBP Ascorbyl Palmitate 8 Heavy MetalsBP Ascorbyl Palmitate 9 Loss on dryingBP Ascorbyl Palmitate 10 Sulfated AshBP Ascorbyl Palmitate 11 Assay (dried substance)BP Asparagine Monohydrate 1 AppearanceBP Asparagine Monohydrate 2 SolubilityBP Asparagine Monohydrate 3 Identification ABP Asparagine Monohydrate 4 Identification BBP Asparagine Monohydrate 5 Identification CBP Asparagine Monohydrate 6 Appearance of SolutionBP Asparagine Monohydrate 7 pHBP Asparagine Monohydrate 8 Specific Optical RotationBP Asparagine Monohydrate 9 Ninhydrin Positive SubstancesBP Asparagine Monohydrate 10 ChloridesBP Asparagine Monohydrate 11 SulfatesBP Asparagine Monohydrate 12 AmmoniaBP Asparagine Monohydrate 13 IronBP Asparagine Monohydrate 14 Heavy MetalsBP Asparagine Monohydrate 15 Loss on DryingBP Asparagine Monohydrate 16 Sulfated AshBP Asparagine Monohydrate 17 AssayBP Aspartame 1 AppearanceBP Aspartame 2 SolubilityBP Aspartame 3 Identification ABP Aspartame 4 Identification BBP Aspartame 5 Identification C

BP Arnica Tincture (Ethanol and/or Methanol & 2-propanol)BP Arnica Tincture (Ethanol and/or Methanol & 2-propanol)

Page 12: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 12 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Aspartame 6 Appearance of solution

BP Aspartame 7 ConductivityBP Aspartame 8 Specific Optical RotationBP Aspartame 9 Related SubstancesBP Aspartame 9 Impurity ABP Aspartame 9 Impurity BBP Aspartame 9 Sum of Impurities other than A and CBP Aspartame 10 Heavy MetalsBP Aspartame 11 Loss on dryingBP Aspartame 12 Sulfated AshBP Aspartame 13 AssayBP Aspartic Acid 1 CharactersBP Aspartic Acid 2 Identification ABP Aspartic Acid 3 Identification BBP Aspartic Acid 4 Identification CBP Aspartic Acid 5 Appearance of solutionBP Aspartic Acid 5 Identification DBP Aspartic Acid 6 Specific Optical RotationBP Aspartic Acid 7 Ninhydrin-positive substancesBP Aspartic Acid 8 ChloridesBP Aspartic Acid 9 SulfatesBP Aspartic Acid 10 AmmoniumBP Aspartic Acid 11 IronBP Aspartic Acid 12 Heavy MetalsBP Aspartic Acid 13 Loss on dryingBP Aspartic Acid 14 Sulfated AshBP Aspartic Acid 15 AssayBP Aspirin 1 AppearanceBP Aspirin 2 SolubilityBP Aspirin 3 Melting pointBP Aspirin 4 Identification ABP Aspirin 5BP Aspirin 6 Identification CBP Aspirin 7 Identification DBP Aspirin 8 Appearance of solutionBP Aspirin 9 Heavy MetalsBP Aspirin 10 Loss on DryingBP Aspirin 11 Sulfated AshBP Aspirin 12 Assay (dried substance)BP Aspirin Tablets 1 IdentificationBP Aspirin Tablets 2 Salicylic acidBP Aspirin Tablets 3 Content of AspirinBP Barbados Aloes 1 AppearanceBP Barbados Aloes 2 SolubilityBP Barbados Aloes 3 Identification ABP Barbados Aloes 4 Identification BBP Barbados Aloes 5 Identification CBP Barbados Aloes 6 Loss on dryingBP Barbados Aloes 7 Total AshBP Barbados Aloes 8 AssayBP Barium Sulfate for Suspension 1 Characteristics

Identification B (Melting point of derivative)

Page 13: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 13 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Barium Sulfate for Suspension 2 Identification A (i)

BP Barium Sulfate for Suspension 2 Identification A (ii)BP Barium Sulfate for Suspension 3 Identification BBP Barium Sulfate for Suspension 4 Acidity or alkalinityBP Barium Sulfate for Suspension 5 Loss on DryingBP Barium Sulfate for Suspension 6 AssayBP Bentonite 1 AppearanceBP Bentonite 2 SolubilityBP Bentonite 3 Identification ABP Bentonite 4 Identification BBP Bentonite 5 Identification CBP Bentonite 6 AlkalinityBP Bentonite 7 Coarse particlesBP Bentonite 8 Heavy MetalsBP Bentonite 9 Loss on dryingBP Bentonite 10 Sedimentation volumeBP Benzaldehyde 1 CharacteristicsBP Benzaldehyde 2 Refractive indexBP Benzaldehyde 3 Weight per millilitreBP Benzaldehyde 4 Free acidBP Benzaldehyde 5 Chlorinated CompoundsBP Benzaldehyde 6 AssayBP Benzalkonium Chloride Solution 1 AppearanceBP Benzalkonium Chloride Solution 2 SolubilityBP Benzalkonium Chloride Solution 3 Identification ABP Benzalkonium Chloride Solution 4 Identification BBP Benzalkonium Chloride Solution 5 Identification CBP Benzalkonium Chloride Solution 6 Identification DBP Benzalkonium Chloride Solution 7 Identification EBP Benzalkonium Chloride Solution 8 Appearance of solutionBP Benzalkonium Chloride Solution 9 Acidity or alkalinityBP Benzalkonium Chloride Solution 10BP Benzalkonium Chloride Solution 10 C12 HomologueBP Benzalkonium Chloride Solution 10 C14 HomologueBP Benzalkonium Chloride Solution 10 Sum of C12 and C14 HomologuesBP Benzalkonium Chloride Solution 11 Impurities A, B & CBP Benzalkonium Chloride Solution 11 Impurity ABP Benzalkonium Chloride Solution 11 Impurity BBP Benzalkonium Chloride Solution 11 Impurity CBP Benzalkonium Chloride Solution 12 Amines and amine saltsBP Benzalkonium Chloride Solution 13 Sulfated AshBP Benzalkonium Chloride Solution 14 AssayBP Benzocaine 1 AppearanceBP Benzocaine 2 SolubilityBP Benzocaine 3 Identification ABP Benzocaine 4 Identification BBP Benzocaine 5 Identification CBP Benzocaine 6 Identification DBP Benzocaine 7 Appearance of solutionBP Benzocaine 8 Acidity or alkalinityBP Benzocaine 9 Loss on drying

Average relative molecular mass & ratio of alkyl components

Page 14: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 14 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Benzocaine 10 Sulfated Ash

BP Benzocaine 11 assayBP Benzoic Acid 1 AppearanceBP Benzoic Acid 2 SolubilityBP Benzoic Acid 3 Identification ABP Benzoic Acid 4 Identification BBP Benzoic Acid 5 Appearance of solutionBP Benzoic Acid 6 Carbonisable substancesBP Benzoic Acid 7 Oxidisable substancesBP Benzoic Acid 8 Halogenated compounds and halidesBP Benzoic Acid 9 Heavy MetalsBP Benzoic Acid 10 Sulfated AshBP Benzoic Acid 11 AssayBP Benzyl Alcohol 1 AppearanceBP Benzyl Alcohol 2 SolubilityBP Benzyl Alcohol 3 Relative densityBP Benzyl Alcohol 4 IdentificationBP Benzyl Alcohol 5 Appearance of solutionBP Benzyl Alcohol 6 AcidityBP Benzyl Alcohol 7 Refractive indexBP Benzyl Alcohol 8 Peroxide ValueBP Benzyl Alcohol 10 Residue on evaporationBP Benzyl Alcohol 11 AssayBP Benzyl Alcohol (Related substances) 9 Related SubstancesBP Benzyl Alcohol (Related substances) 9 Impurity ABP Benzyl Alcohol (Related substances) 9

BP Benzyl Alcohol (Related substances) 9BP Benzyl Alcohol (Related substances) 9 Impurity BBP Benzyl Benzoate 1 AppearanceBP Benzyl Benzoate 2 SolubilityBP Benzyl Benzoate 3 Identification ABP Benzyl Benzoate 4 Identification BBP Benzyl Benzoate 5 Identification CBP Benzyl Benzoate 6 AcidityBP Benzyl Benzoate 7 Relative densityBP Benzyl Benzoate 8 Refractive indexBP Benzyl Benzoate 9 Freezing PointBP Benzyl Benzoate 10 Sulfated AshBP Benzyl Benzoate 11 AssayBP Betacarotene 1 AppearanceBP Betacarotene 2 SolubilityBP Betacarotene 3 IdentificationBP Betacarotene 4 Related SubstancesBP Betacarotene 5 Heavy MetalsBP Betacarotene 6 Loss on DryingBP Betacarotene 7 Sulfated AshBP Betacarotene 8 AssayBP Betamethasone Valerate 1 AppearanceBP Betamethasone Valerate 2 SolubilityBP Betamethasone Valerate 3 Melting pointBP Betamethasone Valerate 4 Identification A

Sum of peaks with a RRT less than that of principal peakSum of peaks with a RRT greater than that of principal peak

Page 15: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 15 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Betamethasone Valerate 6 Specific Optical Rotation

BP Betamethasone Valerate 8 Loss on DryingBP Betamethasone Valerate 9 Assay (dried substance)BP Bethamethasone Valerate 5 Identification BBP Bethamethasone Valerate 7 Related SubstancesBP Biotin 1 CharactersBP Biotin 2 Identification ABP Biotin 3 Identification BBP Biotin 4 Identification CBP Biotin 5 Appearance of solutionBP Biotin 6 Specific Optical RotationBP Biotin 7 Related SubstancesBP Biotin 8 Heavy MetalsBP Biotin 36 Loss on dryingBP Biotin 85 Sulfated AshBP Biotin 130 AssayBP Borax 1 AppearanceBP Borax 2 SolubilityBP Borax 3 Identification ABP Borax 4 Identification BBP Borax 5 Identification CBP Borax 6 Appearance of solutionBP Borax 7 pHBP Borax 8 SulfatesBP Borax 9 AmmoniumBP Borax 10 CalciumBP Borax 10 Heavy MetalsBP Borax 11 AssayBP Boric Acid 1 AppearanceBP Boric Acid 2 SolubilityBP Boric Acid 3 Identification ABP Boric Acid 4 Identification BBP Boric Acid 5 Appearance of solutionBP Boric Acid 6 pHBP Boric Acid 7 Solubility in ethanol (96%)BP Boric Acid 8 Organic MatterBP Boric Acid 9 SulfatesBP Boric Acid 10 Heavy MetalsBP Boric Acid 11 AssayBP Bromelains 1 ActivityBP Bulk Density Bulk DensityBP Buprenorphine Hydrochloride 1 AppearanceBP Buprenorphine Hydrochloride 2 SolubilityBP Buprenorphine Hydrochloride 3 Identification ABP Buprenorphine Hydrochloride 4 Identification BBP Buprenorphine Hydrochloride 5 Appearance of solutionBP Buprenorphine Hydrochloride 6 Acidity or alkalinityBP Buprenorphine Hydrochloride 7 Specific Optical RotationBP Buprenorphine Hydrochloride 8 Related SubstancesBP Buprenorphine Hydrochloride 8 Related SubstancesBP Buprenorphine Hydrochloride 8 BP Buprenorphine HydrochlorideBP Buprenorphine Hydrochloride 8 Impurity A,B,F and J

Page 16: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 16 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Buprenorphine Hydrochloride 8 Total

BP Buprenorphine Hydrochloride 8 Impurity NBP Buprenorphine Hydrochloride 8 Impurity HBP Buprenorphine Hydrochloride 8 Impurities A, J and KBP Buprenorphine Hydrochloride 8 Sum of Impurities I and OBP Buprenorphine Hydrochloride 8 Impurity GBP Buprenorphine Hydrochloride 8 Impurities B, F, L, QBP Buprenorphine Hydrochloride 8 Uspecified ImpuritiesBP Buprenorphine Hydrochloride 9 Loss on DryingBP Buprenorphine Hydrochloride 10 AssayBP Butyl Hydroxybenzoate 1 AppearanceBP Butyl Hydroxybenzoate 2 SolubilityBP Butyl Hydroxybenzoate 3 Identification ABP Butyl Hydroxybenzoate 4 Identification BBP Butyl Hydroxybenzoate 5 Identification CBP Butyl Hydroxybenzoate 6 Appearance of solutionBP Butyl Hydroxybenzoate 7 AcidityBP Butyl Hydroxybenzoate 8 Related SubstancesBP Butyl Hydroxybenzoate 8 unspecified impuritiesBP Butyl Hydroxybenzoate 8 Impurity ABP Butyl Hydroxybenzoate 8 TotalBP Butyl Hydroxybenzoate 9 Sulfated AshBP Butyl Hydroxybenzoate 10 AssayBP Butylated Hydroxyanisole 1 CharactersBP Butylated Hydroxyanisole 2 Identification ABP Butylated Hydroxyanisole 3 Identification BBP Butylated Hydroxyanisole 4 Identification CBP Butylated Hydroxyanisole 5 Appearance of solutionBP Butylated Hydroxyanisole 6 Related SubstancesBP Butylated Hydroxyanisole 7 Heavy metalsBP Butylated Hydroxyanisole 8 Sulfated AshBP Butylated Hydroxytoluene 1 Characters (appearance + solubility)BP Butylated Hydroxytoluene 2 Identification ABP Butylated Hydroxytoluene 3 Identification BBP Butylated Hydroxytoluene 4 Identification CBP Butylated Hydroxytoluene 5 Identification DBP Butylated Hydroxytoluene 6 Appearance of solutionBP Butylated Hydroxytoluene 7 Freezing PointBP Butylated Hydroxytoluene 8 Related SubstancesBP Butylated Hydroxytoluene 9 Sulfated AshBP Caffeine 1 AppearanceBP Caffeine 2 SolubilityBP Caffeine 3 Identification ABP Caffeine 4 Identification BBP Caffeine 5 Identification CBP Caffeine 6 Identification DBP Caffeine 7 Identification EBP Caffeine 8 Identification FBP Caffeine 9 Appearance of solutionBP Caffeine 10 AcidityBP Caffeine 12 SulfatesBP Caffeine 13 Heavy Metals

Page 17: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 17 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Caffeine 14 Loss on drying

BP Caffeine 15 Sulfated AshBP Caffeine 16 AssayBP Caffeine (Related substances) 11 Related SubstancesBP Caffeine (Related substances) 11 TotalBP Caffeine (Related substances) 11 unspecified impuritiesBP Calcium Ascorbate 1 AppearanceBP Calcium Ascorbate 2 SolubilityBP Calcium Ascorbate 3 Identification ABP Calcium Ascorbate 4 Identification BBP Calcium Ascorbate 5 Identification CBP Calcium Ascorbate 6 Identification DBP Calcium Ascorbate 6 Identification EBP Calcium Ascorbate 7 Appearance of solutionBP Calcium Ascorbate 8 pHBP Calcium Ascorbate 9 Specific Optical RotationBP Calcium Ascorbate 10 FluoridesBP Calcium Ascorbate 11 Heavy MetalsBP Calcium Ascorbate 12 Loss on DryingBP Calcium Ascorbate 13 AssayBP Calcium Carbonate 1 AppearanceBP Calcium Carbonate 2 SolubilityBP Calcium Carbonate 3 Identification ABP Calcium Carbonate 4 Identification BBP Calcium Carbonate 5 Substances insoluble in acetic acidBP Calcium Carbonate 6 ChloridesBP Calcium Carbonate 7 SulfatesBP Calcium Carbonate 8 BariumBP Calcium Carbonate 9 IronBP Calcium Carbonate 10 Magnesium and alkali metalsBP Calcium Carbonate 11 Heavy MetalsBP Calcium Carbonate 12 Loss on dryingBP Calcium Chloride Dihydrate 1 AppearanceBP Calcium Chloride Dihydrate 2 SolubilityBP Calcium Chloride Dihydrate 3 Identification ABP Calcium Chloride Dihydrate 4 Identification BBP Calcium Chloride Dihydrate 5 Identification CBP Calcium Chloride Dihydrate 6 Appearance of solutionBP Calcium Chloride Dihydrate 7 Acidity or alkalinityBP Calcium Chloride Dihydrate 8 SulfatesBP Calcium Chloride Dihydrate 9 AluminiumBP Calcium Chloride Dihydrate 10 BariumBP Calcium Chloride Dihydrate 11 IronBP Calcium Chloride Dihydrate 12 Magnesium and alkali metalsBP Calcium Chloride Dihydrate 13 Heavy MetalsBP Calcium Chloride Dihydrate 14 AssayBP Calcium Folinate 1 AppearanceBP Calcium Folinate 2 SolubilityBP Calcium Folinate 3 Identification ABP Calcium Folinate 4 Identification BBP Calcium Folinate 5 Identification CBP Calcium Folinate 6 Identification D

Page 18: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 18 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Calcium Folinate 7 Appearance of solution

BP Calcium Folinate 8 pHBP Calcium Folinate 9 Specific Optical RotationBP Calcium Folinate 10 AcetoneBP Calcium Folinate 10 EthanolBP Calcium Folinate 10 MethanolBP Calcium Folinate 11 Related SubstancesBP Calcium Folinate 11 Impurity ABP Calcium Folinate 11 Impurity BBP Calcium Folinate 11 Impurity CBP Calcium Folinate 11 Impurity DBP Calcium Folinate 11 Impurity EBP Calcium Folinate 11 Impurity FBP Calcium Folinate 11 Impurity GBP Calcium Folinate 11 Sum of impurites other than DBP Calcium Folinate 12 ChloridesBP Calcium Folinate 13 Heavy MetalsBP Calcium Folinate 15 WaterBP Calcium Folinate 16 Assay (anhydrous substance)BP Calcium Folinate 17 Calcium FolinateBP Calcium Gluconate 1 AppearanceBP Calcium Gluconate 2 SolubilityBP Calcium Gluconate 3 Identification ABP Calcium Gluconate 4 Identification BBP Calcium Gluconate 5 Appearance of solutionBP Calcium Gluconate 6 Organic Impurities and Boric AcidBP Calcium Gluconate 7 Sucrose and reducing sugarsBP Calcium Gluconate 8 ChloridesBP Calcium Gluconate 9 SulfatesBP Calcium Gluconate 10 Magnesium and alkali metalsBP Calcium Gluconate 11 Heavy MetalsBP Calcium Gluconate 12 AssayBP Calcium Glycerophosphate 1 AppearanceBP Calcium Glycerophosphate 2 SolubilityBP Calcium Glycerophosphate 3 Identification ABP Calcium Glycerophosphate 4 Identification BBP Calcium Glycerophosphate 5 Identification CBP Calcium Glycerophosphate 6 Appearance of solutionBP Calcium Glycerophosphate 7 Acidity or alkalinityBP Calcium Glycerophosphate 8 Citric acidBP Calcium Glycerophosphate 9 Glycerol and ethanol soluble substancesBP Calcium Glycerophosphate 10 ChloridesBP Calcium Glycerophosphate 11 PhosphatesBP Calcium Glycerophosphate 12 SulfatesBP Calcium Glycerophosphate 13 IronBP Calcium Glycerophosphate 14 Heavy MetalsBP Calcium Glycerophosphate 15 Loss on dryingBP Calcium Glycerophosphate 16 AssayBP Calcium Hydrogen Phosphate 1 AppearanceBP Calcium Hydrogen Phosphate 2 SolubilityBP Calcium Hydrogen Phosphate 3 Identification ABP Calcium Hydrogen Phosphate 4 Identification B

Page 19: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 19 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Calcium Hydrogen Phosphate 5 Identification C

BP Calcium Hydrogen Phosphate 6 acid insoluble substancesBP Calcium Hydrogen Phosphate 7 CarbonatesBP Calcium Hydrogen Phosphate 8 ChloridesBP Calcium Hydrogen Phosphate 9 FluoridesBP Calcium Hydrogen Phosphate 10 SulfatesBP Calcium Hydrogen Phosphate 11 BariumBP Calcium Hydrogen Phosphate 12 IronBP Calcium Hydrogen Phosphate 13 Heavy MetalsBP Calcium Hydrogen Phosphate 14 Loss on ignitionBP Calcium Hydrogen Phosphate 15 AssayBP Calcium Hydroxide 1 Appearance BP Calcium Hydroxide 2 SolubilityBP Calcium Hydroxide 3 Identification ABP Calcium Hydroxide 4 Identification BBP Calcium Hydroxide 5 Matter Insoluble in Hydrochloric AcidBP Calcium Hydroxide 6 CarbonatesBP Calcium Hydroxide 7 ChloridesBP Calcium Hydroxide 8 Magnesium and Alkali MetalsBP Calcium Hydroxide 9 Heavy MetalsBP Calcium Hydroxide 10 AssayBP Calcium Lactate Pentahydrate 1 AppearanceBP Calcium Lactate Pentahydrate 2 SolubilityBP Calcium Lactate Pentahydrate 3 Identification ABP Calcium Lactate Pentahydrate 4 Identification BBP Calcium Lactate Pentahydrate 5 Identification CBP Calcium Lactate Pentahydrate 6 Appearance of solutionBP Calcium Lactate Pentahydrate 7 Acidity or alkalinityBP Calcium Lactate Pentahydrate 8 ChloridesBP Calcium Lactate Pentahydrate 9 SulfatesBP Calcium Lactate Pentahydrate 10 BariumBP Calcium Lactate Pentahydrate 11 IronBP Calcium Lactate Pentahydrate 12 Magnesium and alkali saltsBP Calcium Lactate Pentahydrate 13 Heavy MetalsBP Calcium Lactate Pentahydrate 14 Loss on DryingBP Calcium Lactate Pentahydrate 15 Assay (dried substance)BP Calcium Pantothenate 1 CharactersBP Calcium Pantothenate 2 Identification ABP Calcium Pantothenate 3 Identification BBP Calcium Pantothenate 4 Identification CBP Calcium Pantothenate 5 Identification DBP Calcium Pantothenate 6 Appearance of solutionBP Calcium Pantothenate 7 pHBP Calcium Pantothenate 8 pHBP Calcium Pantothenate 9 Specific Optical RotationBP Calcium Pantothenate 10 3-Aminopropionic acidBP Calcium Pantothenate 11 ChloridesBP Calcium Pantothenate 12 Heavy MetalsBP Calcium Pantothenate 13 Loss on dryingBP Calcium Pantothenate 14 AssayBP Capsules 1 Uniformity of dosage unitsBP Capsules 2 Uniformity of Content

Page 20: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 20 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Capsules 3 Uniformity of mass

BP Capsules 4 Disintegration (soft capsules)BP Capsules 5 Disintegration (gastro-resistant capsules)BP Capsules Disintegration (hard capsules)BP Carbomers 1 AppearanceBP Carbomers 2 SolubilityBP Carbomers 3 Identification ABP Carbomers 4 Identification BBP Carbomers 5 Identification CBP Carbomers 6 Identification DBP Carbomers 8 Heavy MetalsBP Carbomers 9 Loss on dryingBP Carbomers 10 Sulfated AshBP Carbomers 11 AssayBP Carbomers 12 Apparent viscosityBP Carbomers (Benzene) 7 BenzeneBP Carbomers (Free acrylic acid) 6 Free acrylic acidBP Carmellose Sodium 1 CharactersBP Carmellose Sodium 2 Identification ABP Carmellose Sodium 3 Identification BBP Carmellose Sodium 4 Identification CBP Carmellose Sodium 5 Appearance of solutionBP Carmellose Sodium 6 pHBP Carmellose Sodium 7 Apparent viscosityBP Carmellose Sodium 8 Sodium glycolateBP Carmellose Sodium 9 ChloridesBP Carmellose Sodium 10 Heavy MetalsBP Carmellose Sodium 11 Loss on dryingBP Carmellose Sodium 12 Sulfated AshBP Carnauba Wax 1 AppearanceBP Carnauba Wax 2 SolubilityBP Carnauba Wax 3 Relative densityBP Carnauba Wax 4 IdentificationBP Carnauba Wax 5 Appearance of solutionBP Carnauba Wax 6 Melting pointBP Carnauba Wax 7 Acid ValueBP Carnauba Wax 8 Saponification ValueBP Carnauba Wax 9 Total AshBP Cetomacrogol Emulsifying Wax 1 AppearanceBP Cetomacrogol Emulsifying Wax 2 SolubilityBP Cetomacrogol Emulsifying Wax 3 Identification ABP Cetomacrogol Emulsifying Wax 4 Identification BBP Cetomacrogol Emulsifying Wax 5 Acid ValueBP Cetomacrogol Emulsifying Wax 6 Refractive indexBP Cetomacrogol Emulsifying Wax 7 Solidifying pointBP Cetomacrogol Emulsifying Wax 8 AlkalinityBP Cetomacrogol Emulsifying Wax 9 Hydroxyl ValueBP Cetomacrogol Emulsifying Wax 10 Saponification ValueBP Cetomacrogol Emulsifying Wax 11 Sulfated AshBP Cetostearyl Alcohol 1 AppearanceBP Cetostearyl Alcohol 2 SolubilityBP Cetostearyl Alcohol 4 Appearance of solution

Page 21: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 21 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Cetostearyl Alcohol 5 Melting point

BP Cetostearyl Alcohol 6 Acid ValueBP Cetostearyl Alcohol 7 Hydroxyl ValueBP Cetostearyl Alcohol 8 Iodine ValueBP Cetostearyl Alcohol 9 Saponification ValueBP Cetostearyl Alcohol (ID and/or Assay) 3 IdentificationBP Cetostearyl Alcohol (ID and/or Assay) 10 AssayBP Cetostearyl Alcohol (ID and/or Assay) 10 Stearyl AlcoholBP Cetostearyl Alcohol (ID and/or Assay) 10BP Cetrimide 1 AppearanceBP Cetrimide 2 SolubilityBP Cetrimide 3 Identification ABP Cetrimide 4 Identification BBP Cetrimide 5 Identification CBP Cetrimide 6 Identification DBP Cetrimide 7 Identification EBP Cetrimide 8 Appearance of solutionBP Cetrimide 9 Acidity or alkalinityBP Cetrimide 10 Amine and amine saltsBP Cetrimide 11 Loss on DryingBP Cetrimide 12 Sulfated AshBP Cetrimide 13 Assay (dried substance)BP Cetrimide Solution 1 Identification ABP Cetrimide Solution 2 Identification BBP Cetrimide Solution 3 Identification CBP Cetrimide Solution 4 AssayBP Cetyl Alcohol 1 AppearanceBP Cetyl Alcohol 2 SolubilityBP Cetyl Alcohol 4 Appearance of solutionBP Cetyl Alcohol 5 Melting pointBP Cetyl Alcohol 6 Acid ValueBP Cetyl Alcohol 7 Hydroxyl ValueBP Cetyl Alcohol 8 Iodine ValueBP Cetyl Alcohol 9 Saponification ValueBP Cetyl Alcohol (ID and/or Assay) 3 IdentificationBP Cetyl Alcohol (ID and/or Assay) 10 AssayBP Cetyl Palmitate 1 AppearanceBP Cetyl Palmitate 2 SolubilityBP Cetyl Palmitate 3 Melting pointBP Cetyl Palmitate 5 Identification BBP Cetyl Palmitate 6 Appearance of solutionBP Cetyl Palmitate 7 Acid ValueBP Cetyl Palmitate 8 Hydroxyl ValueBP Cetyl Palmitate 9 Iodine ValueBP Cetyl Palmitate 10 Saponification ValueBP Cetyl Palmitate 11 Alkaline ImpuritiesBP Cetyl Palmitate 12 waterBP Cetyl Palmitate 13 Total AshBP Cetyl Palmitate (ID A and/or Assay) 4 Identification ABP Cetyl Palmitate (ID A and/or Assay) 14 AssayBP Chloramphenicol Sodium Succinate 1 Appearance

Sum of the contents of stearyl alcohol and cetyl alcohol

Page 22: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 22 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Chloramphenicol Sodium Succinate 2 Solubility

BP Chloramphenicol Sodium Succinate 3 Identification ABP Chloramphenicol Sodium Succinate 4 Identification BBP Chloramphenicol Sodium Succinate 5 Identification CBP Chloramphenicol Sodium Succinate 6 Identification DBP Chloramphenicol Sodium Succinate 7 pHBP Chloramphenicol Sodium Succinate 8 Specific Optical RotationBP Chloramphenicol Sodium Succinate 9BP Chloramphenicol Sodium Succinate 9 Chloramphenicol disodium disuccinateBP Chloramphenicol Sodium Succinate 9 ChloramphenicolBP Chloramphenicol Sodium Succinate 10 WaterBP Chloramphenicol Sodium Succinate 11 AssayBP Chlorhexadine Acetate 1 AppearanceBP Chlorhexadine Acetate 3 Identification ABP Chlorhexadine Acetate 4 Identification BBP Chlorhexadine Acetate 5 Identification CBP Chlorhexadine Acetate 6 Identification DBP Chlorhexadine Acetate 7 ChloroanilineBP Chlorhexadine Acetate 8 Related SubstancesBP Chlorhexadine Acetate 8 TotalBP Chlorhexadine Acetate 9 Loss on DryingBP Chlorhexadine Acetate 10 Sulfated AshBP Chlorhexadine Acetate 11 Assay (dried substance)BP Chlorhexadine Acetate 23 SolubilityBP Chlorhexidine Gluconate Solution 1 AppearanceBP Chlorhexidine Gluconate Solution 2 SolubilityBP Chlorhexidine Gluconate Solution 3 Identification ABP Chlorhexidine Gluconate Solution 4 Identification BBP Chlorhexidine Gluconate Solution 5 Identification CBP Chlorhexidine Gluconate Solution 6 Identification DBP Chlorhexidine Gluconate Solution 7 Relative densityBP Chlorhexidine Gluconate Solution 8 pHBP Chlorhexidine Gluconate Solution 9 Impurity P (Chloroaniline)BP Chlorhexidine Gluconate Solution 11 Assay

10 Related Substances

10 Total limitBP Chlorhexidine hydrochloride 1 Appearance BP Chlorhexidine hydrochloride 2 SolubilityBP Chlorhexidine hydrochloride 3 Identification ABP Chlorhexidine hydrochloride 4 Identification BBP Chlorhexidine hydrochloride 5 Identification CBP Chlorhexidine hydrochloride 6 Identification DBP Chlorhexidine hydrochloride 7 ChloroanilineBP Chlorhexidine hydrochloride 8 Related SubstancesBP Chlorhexidine hydrochloride 8 TotalBP Chlorhexidine hydrochloride 9 Loss on DryingBP Chlorhexidine hydrochloride 10 Sulfated AshBP Chlorhexidine hydrochloride 11 AssayBP Chlorobutanol 1 AppearanceBP Chlorobutanol 2 Solubility

Chloramphenicol and Chloramphenicol disodium disuccinate

BP Chlorhexidine Gluconate Solution (Related substances)BP Chlorhexidine Gluconate Solution (Related substances)

Page 23: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 23 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Chlorobutanol 3 Melting point

BP Chlorobutanol 4 Identification ABP Chlorobutanol 5 Identification BBP Chlorobutanol 6 Identification cBP Chlorobutanol 7 Identification DBP Chlorobutanol 8 Appearance of solutionBP Chlorobutanol 9 AcidityBP Chlorobutanol 10 ChloridesBP Chlorobutanol 11 WaterBP Chlorobutanol 12 Sulfated AshBP Chlorobutanol 13 AssayBP Chlorocresol 1 AppearanceBP Chlorocresol 2 SolubilityBP Chlorocresol 3 Identification ABP Chlorocresol 4 Identification BBP Chlorocresol 5 Appearance of solutionBP Chlorocresol 6 AcidityBP Chlorocresol 8 Non-volatile matterBP Chlorocresol 9 AssayBP Chlorocresol (Related Substances) 7 Related SubstancesBP Chlorocresol (Related Substances) 7 TotalBP Chlorocresol (Related Substances) 7 unspecified impuritiesBP Chloroxylenol 1 CharactersBP Chloroxylenol 2 Identification ABP Chloroxylenol 3 Identification BBP Chloroxylenol 4 Identification CBP Chloroxylenol 5 Identification DBP Chloroxylenol 6 Melting pointBP Chloroxylenol 8 AssayBP Chloroxylenol (Related substances) 7 Related SubstancesBP Chlorphenamine Maleate 1 AppearanceBP Chlorphenamine Maleate 2 SolubilityBP Chlorphenamine Maleate 3 Identification ABP Chlorphenamine Maleate 4 Identification BBP Chlorphenamine Maleate 5 Identification CBP Chlorphenamine Maleate 6 Appearance of solutionBP Chlorphenamine Maleate 7 Optical rotationBP Chlorphenamine Maleate 8 Heavy MetalsBP Chlorphenamine Maleate 9 Loss on DryingBP Chlorphenamine Maleate 10 Sulfated AshBP Chlorphenamine Maleate 11 Assay (dried substance)BP Cholesterol 1 AppearanceBP Cholesterol 2 SolubilityBP Cholesterol 3 Identification ABP Cholesterol 4 Identification BBP Cholesterol 5 Identification CBP Cholesterol 6 Solubility in ethanol (96%)BP Cholesterol 7 AcidityBP Cholesterol 8 Loss on DryingBP Cholesterol 9 Sulfated AshBP Cholesterol 10 AssayBP Cholesterol 10 Total sterols

Page 24: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 24 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Cholesterol 10 Cholesterol

BP Chondroitin Sulfate Sodium 1 AppearanceBP Chondroitin Sulfate Sodium 2 SolubilityBP Chondroitin Sulfate Sodium 3 Identification ABP Chondroitin Sulfate Sodium 4 Identification BBP Chondroitin Sulfate Sodium 5 pHBP Chondroitin Sulfate Sodium 6 Specific Optical RotationBP Chondroitin Sulfate Sodium 7 Intrinsic viscosityBP Chondroitin Sulfate Sodium 8 ProteinBP Chondroitin Sulfate Sodium 9 ChloridesBP Chondroitin Sulfate Sodium 10 Heavy MetalsBP Chondroitin Sulfate Sodium 11 Loss on DryingBP Chondroitin Sulfate Sodium 12 AssayBP Cineole 1 AppearanceBP Cineole 2 SolubilityBP Cineole 3 Identification ABP Cineole 4 Identification BBP Cineole 5 Identification CBP Cineole 6 Appearance of solutionBP Cineole 7 Chiral impurities (Optical rotation)BP Cineole 8 Refractive indexBP Cineole 10 Residue on evaporationBP Cineole (Related substances) 9 Related SubstancesBP Cineole (Related substances) 9 TotalBP Citric Acid Monohydrate 1 AppearanceBP Citric Acid Monohydrate 2 SolubilityBP Citric Acid Monohydrate 3 Identification ABP Citric Acid Monohydrate 4 Identification BBP Citric Acid Monohydrate 5 Identification CBP Citric Acid Monohydrate 6 Identification DBP Citric Acid Monohydrate 7 Identification EBP Citric Acid Monohydrate 8 Appearance of solutionBP Citric Acid Monohydrate 9 Readily carbonisable substancesBP Citric Acid Monohydrate 10 Oxalic acidBP Citric Acid Monohydrate 11 SulfatesBP Citric Acid Monohydrate 12 AluminiumBP Citric Acid Monohydrate 13 Heavy MetalsBP Citric Acid Monohydrate 14 WaterBP Citric Acid Monohydrate 15 Sulfated AshBP Citric Acid Monohydrate 16 AssayBP Clofazimine 1 Appearance BP Clofazimine 1 Appearance BP Clofazimine 2 solubilityBP Clofazimine 2 SolubilityBP Clofazimine 3 Identification ABP Clofazimine 3 Identification ABP Clofazimine 4 Identification BBP Clofazimine 4 Identification BBP Clofazimine 5 Identification CBP Clofazimine 5 Identification CBP Clofazimine 6 Related SubstancesBP Clofazimine 6 Related Substances

Page 25: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 25 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Clofazimine 6 Impurity A

BP Clofazimine 6 Impurity BBP Clofazimine 6 Any other ImpurityBP Clofazimine 6 TotalBP Clofazimine 6 Impurity ABP Clofazimine 6 Impurity BBP Clofazimine 6 any other impurityBP Clofazimine 6 TotalBP Clofazimine 7 Heavy Metals (Method C)BP Clofazimine 7 Heavy MetalsBP Clofazimine 8 Loss on DryingBP Clofazimine 8 Loss on DryingBP Clofazimine 9 Sulfated AshBP Clofazimine 9 Sulfated AshBP Clofazimine 10 AssayBP Clofazimine 10 AssayBP Clotrimazole 1 AppearanceBP Clotrimazole 2 SolubilityBP Clotrimazole 3 Identification ABP Clotrimazole 4 Identification BBP Clotrimazole 5 Identification CBP Clotrimazole 7 Loss on dryingBP Clotrimazole 8 Sulfated AshBP Clotrimazole 9 AssayBP Clotrimazole (Related substances) 6 Related SubstancesBP Clotrimazole (Related substances) 6 Impurities D, EBP Clotrimazole (Related substances) 6 Impurity FBP Clotrimazole (Related substances) 6 unspecified impuritiesBP Clotrimazole (Related substances) 6 Impurities A, BBP Clotrimazole (Related substances) 6 TotalBP Clotrimazole Cream 1 Identification BBP Cloud Point 1 Cloud PointBP Cloxacillin Benzathine 1 CharactersBP Cloxacillin Benzathine 2 Identification ABP Cloxacillin Benzathine 3 Identification BBP Cloxacillin Benzathine 4 Identification CBP Cloxacillin Benzathine 5 WaterBP Cloxacillin Benzathine 6 Cloxacillin benzathine (assay)BP Cloxacillin Benzathine 7 Benzathine (assay)BP Coconut Oil 1 AppearanceBP Coconut Oil 2 SolubilityBP Coconut Oil 3 Refractive indexBP Coconut Oil 4 Identification ABP Coconut Oil 6 Melting pointBP Coconut Oil 7 Acid ValueBP Coconut Oil 8 Peroxide ValueBP Coconut Oil 9 Unsaponifiable matterBP Coconut Oil 10 Alkaline ImpuritiesBP Coconut Oil 12 Water

5 Identification B

11 Composition of fatty acids

BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)

Page 26: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 26 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

11 Caproic Acid

11 Caprylic acid

11 Capric acid

11 Lauric acid

11 Myristic acid

11 Palmitic acid

11 Eicosenoic acid

11 Arachidic acid

11 Linolenic acid

11 Linoleic acid

11 Stearic acid

11 Oleic acid and isomersBP Codeine Phosphate 1 AppearanceBP Codeine Phosphate 2 SolubilityBP Codeine Phosphate 3 Identification ABP Codeine Phosphate 4 Identification BBP Codeine Phosphate 5 Identification CBP Codeine Phosphate 6 Identification DBP Codeine Phosphate 7 Identification EBP Codeine Phosphate 8 Identification FBP Codeine Phosphate 9 Identification GBP Codeine Phosphate 10 pHBP Codeine Phosphate 11 Specific Optical RotationBP Codeine Phosphate 13 SulfatesBP Codeine Phosphate 14 Loss on DryingBP Codeine Phosphate 15 Assay

12 Related Substances12 Sum of impurities B and E12 Impurities C, D12 Sum of impurities other than A12 Impurity A12 unspecified impurities

BP Cod-liver Oil (Type A) 1 AppearanceBP Cod-liver Oil (Type A) 2 SolubilityBP Cod-liver Oil (Type A) 6 Identification DBP Cod-liver Oil (Type A) 7 Appearance (Tests)BP Cod-liver Oil (Type A) 8 Relative densityBP Cod-liver Oil (Type A) 9 Refractive indexBP Cod-liver Oil (Type A) 10 Acid ValueBP Cod-liver Oil (Type A) 11 Anisidine ValueBP Cod-liver Oil (Type A) 12 Iodine Value

BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)BP Coconut Oil (ID B and/or Composition of fatty acids)

BP Codeine Phosphate (Related substances)BP Codeine Phosphate (Related substances)BP Codeine Phosphate (Related substances)BP Codeine Phosphate (Related substances)BP Codeine Phosphate (Related substances)BP Codeine Phosphate (Related substances)

Page 27: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 27 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Cod-liver Oil (Type A) 13 Peroxide Value

BP Cod-liver Oil (Type A) 14 Unsaponifiable matterBP Cod-liver Oil (Type A) 15 StearinBP Cod-liver Oil (Type A) 17 Vitamin A (Method A)

3 Identification A

4 Identification B

18 Vitamin A (Method B)

19 Vitamin D3

5 Identification C

16 Composition of fatty acids

16 Gondoic Acid

16 Moroctic Acid

16 Erucic acid

16 Oleic acid

16 Palmitoleic acid

16 Stearic acid

16

16 Cetoleic acid

16 Cervonic (docosahexaenioc) acid (DHA)

16 Linoleic acid

16 Gadoleic acid

16 cis-Vaccenic acid

16 Palmitic acid

16 a-Linolenic Acid

16 Myristic acidBP Colecalciferol 1 AppearanceBP Colecalciferol 2 SolubilityBP Colecalciferol 3 IdentificationBP Colecalciferol 4 Specific Optical Rotation

5 Related Substances

5 Impurity A

BP Cod-liver Oil (Type A) (ID A and/or ID B and/or Assay)BP Cod-liver Oil (Type A) (ID A and/or ID B and/or Assay)BP Cod-liver Oil (Type A) (ID A and/or ID B and/or Assay)BP Cod-liver Oil (Type A) (ID A and/or ID B and/or Assay)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)

Timnodonic (eicosapentaenoic) acid (EPA)

BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)BP Cod-liver Oil (Type A) (ID C and/or Composition of fatty acids)

BP Colecalciferol (Assay and/or Related substances)BP Colecalciferol (Assay and/or Related substances)

Page 28: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 28 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

5 Total

5 unspecified impurities

6 AssayBP Colecalciferol Concentrate (Oily Form) 1 AppearanceBP Colecalciferol Concentrate (Oily Form) 2 SolubilityBP Colecalciferol Concentrate (Oily Form) 3 Identification ABP Colecalciferol Concentrate (Oily Form) 4 Identification BBP Colecalciferol Concentrate (Oily Form) 6 Acid ValueBP Colecalciferol Concentrate (Oily Form) 7 Peroxide Value

5 Identification C

9 Assay

10 Related Substances

1 Appearance

2 Solubility

3 Identification A

4 Identification B

5 Identification C

6 Test Solution

7 AssayBP Colloidal Anhydrous Silica 1 DescriptionBP Colloidal Anhydrous Silica 2 SolubilityBP Colloidal Anhydrous Silica 3 IdentificationBP Colloidal Anhydrous Silica 4 pHBP Colloidal Anhydrous Silica 5 ChloridesBP Colloidal Anhydrous Silica 6 Heavy MetalsBP Colloidal Anhydrous Silica 7 Loss on ignitionBP Colloidal Anhydrous Silica 8 Assay (ignited substance)BP Colloidal Hydrated Silica 1 CharactersBP Colloidal Hydrated Silica 2 Identification ABP Colloidal Hydrated Silica 3 Identification BBP Colloidal Hydrated Silica 4 Preparation of Solution SBP Colloidal Hydrated Silica 5 pHBP Colloidal Hydrated Silica 6 Water-sbsorption capacityBP Colloidal Hydrated Silica 7 Substances soluble in hydrochloric acidBP Colloidal Hydrated Silica 8 ChloridesBP Colloidal Hydrated Silica 9 SulfatesBP Colloidal Hydrated Silica 10 Iron

BP Colecalciferol (Assay and/or Related substances)BP Colecalciferol (Assay and/or Related substances)BP Colecalciferol (Assay and/or Related substances)

BP Colecalciferol Concentrate (Oily Form) (ID C and/or Assay and/or Related substances)BP Colecalciferol Concentrate (Oily Form) (ID C and/or Assay and/or Related substances)BP Colecalciferol Concentrate (Oily Form) (ID C and/or Assay and/or Related substances)BP Colecalciferol Concentrate (Powder Form)BP Colecalciferol Concentrate (Powder Form)BP Colecalciferol Concentrate (Powder Form)BP Colecalciferol Concentrate (Powder Form)BP Colecalciferol Concentrate (Powder Form)BP Colecalciferol Concentrate (Powder Form)BP Colecalciferol Concentrate (Powder Form)

Page 29: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 29 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Colloidal Hydrated Silica 11 Heavy Metals

BP Colloidal Hydrated Silica 12 Loss on ignitionBP Colloidal Hydrated Silica 13 AssayBP Colophony 1 Identification ABP Colophony 2 Identification BBP Colophony 3 Acid ValueBP Colophony 4 Total AshBP Complexometric Titration 1 AluminiumBP Complexometric Titration 2 BismuthBP Complexometric Titration 3 CalciumBP Complexometric Titration 4 LeadBP Complexometric Titration 5 MagnesiumBP Complexometric Titration 6 Zinc

2 Identification B

3 Identification C

4 Identification D

9 Magnesium Oxide

10 Citric acid anhydrous

1 Identification A

5 Impurity A

6 Uniformity of Content - 10

6 Uniformity of Content - 9

6 Uniformity of Content - 8

6 Uniformity of Content - 7

6 Uniformity of Content - 6

6 Uniformity of Content - 5

6 Uniformity of Content - 4

6 Uniformity of Content - 3

6 Uniformity of Content - 2

6 Uniformity of Content - 1

7 Sachet Fill Weight - 5

7 Sachet Fill Weight - 7

7 Sachet Fill Weight - 6

BP Compound Sodium Picosulfate Powder for oral SolutionBP Compound Sodium Picosulfate Powder for oral SolutionBP Compound Sodium Picosulfate Powder for oral SolutionBP Compound Sodium Picosulfate Powder for oral SolutionBP Compound Sodium Picosulfate Powder for oral SolutionBP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)

Page 30: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 30 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

7 Sachet Fill Weight - 4

7 Sachet Fill Weight - 3

7 Sachet Fill Weight - 2

7 Sachet Fill Weight - 1

7 Sachet Fill Weight - 10

7 Sachet Fill Weight - 9

7 Sachet Fill Weight - 8

8 AssayBP Copper Sulfate Pentahydrate 1 AppearanceBP Copper Sulfate Pentahydrate 2 SolubilityBP Copper Sulfate Pentahydrate 3 Identification ABP Copper Sulfate Pentahydrate 4 Identification BBP Copper Sulfate Pentahydrate 5 Identification CBP Copper Sulfate Pentahydrate 6 Appearance of solutionBP Copper Sulfate Pentahydrate 7 ChloridesBP Copper Sulfate Pentahydrate 8 Loss on dryingBP Copper Sulfate Pentahydrate 9 AssayBP Coriander Oil 1 AppearanceBP Coriander Oil 2 Identification ABP Coriander Oil 3 Identification BBP Coriander Oil 4 Relative densityBP Coriander Oil 5 Refractive indexBP Coriander Oil 6 Optical rotationBP Coriander Oil 7 Acid ValueBP Coriander Oil 8 Chromatographic ProfileBP Coriander Oil 8 GeraniolBP Coriander Oil 8 Geranyl acetateBP Coriander Oil 8 LinalolBP Coriander Oil 8 p-CymeneBP Coriander Oil 8 LimoneneBP Coriander Oil 8 alpha-PineneBP Coriander Oil 8 CamphorBP Coriander Oil 8 gamma-TerpineneBP Coriander Oil 8 alpha-TerpineolBP Cresol 1 CharacteristicsBP Cresol 2 Identification ABP Cresol 3 Identification BBP Cresol 4 AcidityBP Cresol 5 Distillation rangeBP Cresol 6 Weight per millilitreBP Cresol 7 HydrocarbonsBP Cresol 8 Volatile basesBP Cresol 9 Hydrocarbons and Volatile basesBP Cresol 10 Sulfur CompoundsBP Cresol 11 Non-volatile matter

BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)BP Compound Sodium Picosulfate Powder for Oral Solution (Uniformity of Content)

Page 31: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 31 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Croscarmellose Sodium 1 Appearance

BP Croscarmellose Sodium 2 SolubilityBP Croscarmellose Sodium 3 Identification ABP Croscarmellose Sodium 4 Identification BBP Croscarmellose Sodium 5 Identification CBP Croscarmellose Sodium 6 pHBP Croscarmellose Sodium 7 Sodium chloride and sodium glycollateBP Croscarmellose Sodium 8 Water soluble substancesBP Croscarmellose Sodium 9 Heavy MetalsBP Croscarmellose Sodium 10 Loss on dryingBP Croscarmellose Sodium 11 Sulfated AshBP Crospovidone 1 AppearanceBP Crospovidone 2 SolubilityBP Crospovidone 3 Identification ABP Crospovidone 4 Identification BBP Crospovidone 5 Identification CBP Crospovidone 6 Identification DBP Crospovidone 7 PeroxidesBP Crospovidone 8 Water soluble substancesBP Crospovidone 10 Heavy MetalsBP Crospovidone 11 Loss on dryingBP Crospovidone 12 Sulphated AshBP Crospovidone 13 AssayBP Crospovidone (Impurity A) 9 Impurity ABP Cyanocobalamin 1 AppearanceBP Cyanocobalamin 2 SolubilityBP Cyanocobalamin 3 Identification ABP Cyanocobalamin 4 Identification BBP Cyanocobalamin 6 Loss on dryingBP Cyanocobalamin 7 AssayBP Cyanocobalamin (Related substances) 5 Related SubstancesBP Cyanocobalamin (Related substances) 5 TotalBP Decyl Oleate 1 AppearanceBP Decyl Oleate 2 SolubilityBP Decyl Oleate 3 Identification ABP Decyl Oleate 4 Identification BBP Decyl Oleate 6 Relative densityBP Decyl Oleate 7 Acid ValueBP Decyl Oleate 8 Iodine ValueBP Decyl Oleate 9 Peroxide ValueBP Decyl Oleate 10 Saponification ValueBP Decyl Oleate 12 WaterBP Decyl Oleate 13 Total AshBP Decyl Oleate (ID C and/or Oleic acid) 5 Identification CBP Decyl Oleate (ID C and/or Oleic acid) 11 Oleic acidBP Dementholised Mint Oil 1 AppearanceBP Dementholised Mint Oil 2 Identification ABP Dementholised Mint Oil 4 Relative densityBP Dementholised Mint Oil 5 Refractive indexBP Dementholised Mint Oil 6 Optical RotationBP Dementholised Mint Oil 7 Acid Value

Page 32: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 32 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

3 Identification B

8 Chromatographic Profile

8 Menthone

8 Isopulegol

8 Menthol

8 Carvone

8 Limonene

8 Cineole

8 Isomenthone

8 Menthyl acetate

8 PulegoneBP Dental-type Silica 1 AppearanceBP Dental-type Silica 2 SolubilityBP Dental-type Silica 3 IdentificationBP Dental-type Silica 4 Solution SBP Dental-type Silica 5 pHBP Dental-type Silica 6 ChloridesBP Dental-type Silica 7 SulfatesBP Dental-type Silica 8 IronBP Dental-type Silica 9 Heavy MetalsBP Dental-type Silica 10 Loss on ignitionBP Dental-type Silica 11 AssayBP Determination of Distillation Range 1 Dry pointBP Determination of Distillation Range 1 Distillation rangeBP Determination of Ethanol 1 Ethanol (Method I)BP Determination of Ethanol 2 Ethanol (Method II)BP Determination of Ethanol 3 Ethanol (Method III)BP Determination of Freezing Point 1 Freezing Point

1 Method A

2 Method B

3 Methanol

4 2-Propanol

1 Optical rotation

1 Specific Optical RotationBP Determination of pH Values 1 pHBP Determination of Refractive Index 1 Refractive indexBP Determination of Sulfated Ash 1 Sulfated Ash

BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)BP Dementholised Mint Oil (Chrom Profile and/or ID B)

BP Determination of Methanol and Propan-2-olBP Determination of Methanol and Propan-2-olBP Determination of Methanol and Propan-2-olBP Determination of Methanol and Propan-2-olBP Determination of Optical & Specific Optical RotationBP Determination of Optical & Specific Optical Rotation

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 33 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Determination of Sulfur Dioxide 1 Sulfur Dioxide

BP Determination of Water 1 Water1 Weight per millilitre

1 Density at 25°C

1 Density at 15°C

1 Density at 20°C

1 Apparent density

1 Relative density

1 DensityBP Dexamethasone 1 AppearanceBP Dexamethasone 2 SolubilityBP Dexamethasone 3 Identification ABP Dexamethasone 4 Identification BBP Dexamethasone 5 Identification CBP Dexamethasone 6 Identification DBP Dexamethasone 7 Identification EBP Dexamethasone 8 Specific Optical RotationBP Dexamethasone 9 Related SubstancesBP Dexamethasone 9 Impurity GBP Dexamethasone 9 Impurities B, FBP Dexamethasone 9 Unspecified ImpuritiesBP Dexamethasone 9 TotalBP Dexamethasone 10 Loss on DryingBP Dexamethasone 11 AssayBP Dexamethasone Eye Drops, Suspension 1 IdentificationBP Dexamethasone Eye Drops, Suspension 2 Acidity

3 AssayBP Dexamethasone Sodium Phosphate 1 AppearanceBP Dexamethasone Sodium Phosphate 2 SolubilityBP Dexamethasone Sodium Phosphate 3 Identification ABP Dexamethasone Sodium Phosphate 4 Identification BBP Dexamethasone Sodium Phosphate 5 Identification CBP Dexamethasone Sodium Phosphate 6 Identification DBP Dexamethasone Sodium Phosphate 7 Identification EBP Dexamethasone Sodium Phosphate 8 Identification FBP Dexamethasone Sodium Phosphate 9 Identification GBP Dexamethasone Sodium Phosphate 10 Appearance of SolutionBP Dexamethasone Sodium Phosphate 11 pHBP Dexamethasone Sodium Phosphate 12 Specific Optical RotationBP Dexamethasone Sodium Phosphate 13 Related SubstancesBP Dexamethasone Sodium Phosphate 13 unspecified impuritiesBP Dexamethasone Sodium Phosphate 13 Impurity GBP Dexamethasone Sodium Phosphate 13 TotalBP Dexamethasone Sodium Phosphate 13 Impurity ABP Dexamethasone Sodium Phosphate 14 Inorganic Phosphates

BP Determination of Weight per mL, Density, Relative Density & ApparentBP Determination of Weight per mL, Density, Relative Density & ApparentBP Determination of Weight per mL, Density, Relative Density & ApparentBP Determination of Weight per mL, Density, Relative Density & ApparentBP Determination of Weight per mL, Density, Relative Density & ApparentBP Determination of Weight per mL, Density, Relative Density & ApparentBP Determination of Weight per mL, Density, Relative Density & Apparent

BP Dexamethasone Eye Drops, Suspension (Assay)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 34 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Dexamethasone Sodium Phosphate 15 Ethanol

BP Dexamethasone Sodium Phosphate 16 Ethanol and WaterBP Dexamethasone Sodium Phosphate 17 Assay (dried basis)BP Dexamethasone Sodium Phosphate 17 Assay (as is basis)BP Dexpanthenol 1 CharactersBP Dexpanthenol 2 Identification ABP Dexpanthenol 3 Identification BBP Dexpanthenol 4 Identification CBP Dexpanthenol 5 Identification DBP Dexpanthenol 6 Appearance of solutionBP Dexpanthenol 7 pHBP Dexpanthenol 8 Specific Optical RotationBP Dexpanthenol 9 3 - AminopropanolBP Dexpanthenol 10 Heavy MetalsBP Dexpanthenol 11 WaterBP Dexpanthenol 12 Sulfated AshBP Dexpanthenol 200 AssayBP Dextromethorphan Hydrobromide 1 AppearanceBP Dextromethorphan Hydrobromide 2 SolubilityBP Dextromethorphan Hydrobromide 3 Melting pointBP Dextromethorphan Hydrobromide 4 Identification ABP Dextromethorphan Hydrobromide 5 Identification BBP Dextromethorphan Hydrobromide 6 Identification CBP Dextromethorphan Hydrobromide 7 Identification DBP Dextromethorphan Hydrobromide 8 Appearance of solutionBP Dextromethorphan Hydrobromide 9 Acidity or alkalinityBP Dextromethorphan Hydrobromide 10 Specific Optical RotationBP Dextromethorphan Hydrobromide 12 N,N-DimethylanilineBP Dextromethorphan Hydrobromide 13 WaterBP Dextromethorphan Hydrobromide 14 Sulfated AshBP Dextromethorphan Hydrobromide 15 Assay

11 Related Substances

11 Impurities A, B, C, D

11 unspecified impurities

11 TotalBP Dichloromethane 1 AppearanceBP Dichloromethane 2 SolubilityBP Dichloromethane 3 Identification ABP Dichloromethane 4 Identification BBP Dichloromethane 5 Identification CBP Dichloromethane 6 Identification DBP Dichloromethane 7 Identification EBP Dichloromethane 8 Appearance (Tests)BP Dichloromethane 9 AcidityBP Dichloromethane 10 Relative DensityBP Dichloromethane 11 Refractive IndexBP Dichloromethane 12BP Dichloromethane 12 Ethanol

BP Dextromethorphan Hydrobromide (Related substances)BP Dextromethorphan Hydrobromide (Related substances)BP Dextromethorphan Hydrobromide (Related substances)BP Dextromethorphan Hydrobromide (Related substances)

Ethanol, 2-methylbut-2-ene and volatile Impurities

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 35 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Dichloromethane 12 2-methylbut-2-ene

BP Dichloromethane 12 Impurity ABP Dichloromethane 12 Impurity BBP Dichloromethane 12BP Dichloromethane 13 Free ChlorineBP Dichloromethane 14 Heavy MetalsBP Dichloromethane 15 Residue on EvaporationBP Dichloromethane 16 WaterBP Diethylene Glycol Monoethyl Ether 1 Appearance BP Diethylene Glycol Monoethyl Ether 2 SolubilityBP Diethylene Glycol Monoethyl Ether 3 Relative DensityBP Diethylene Glycol Monoethyl Ether 4 Identification ABP Diethylene Glycol Monoethyl Ether 5 Identification BBP Diethylene Glycol Monoethyl Ether 6 Acid ValueBP Diethylene Glycol Monoethyl Ether 7 Peroxide ValueBP Diethylene Glycol Monoethyl Ether 8 Related SubstancesBP Diethylene Glycol Monoethyl Ether 8 Ethylene Glycol Monomethyl EtherBP Diethylene Glycol Monoethyl Ether 8 Ethylene Glycol Monoethyl EtherBP Diethylene Glycol Monoethyl Ether 8 Ethylene GlycolBP Diethylene Glycol Monoethyl Ether 8 Diethylene GlycolBP Diethylene Glycol Monoethyl Ether 8 TotalBP Diethylene Glycol Monoethyl Ether 9 Ethylene OxideBP Diethylene Glycol Monoethyl Ether 10 WaterBP Dilute Sulfuric Acid 1 Weight per millilitreBP Dilute Sulfuric Acid 2 AssayBP Dimethyl Sulfoxide 1 Appearance BP Dimethyl Sulfoxide 2 SolubilityBP Dimethyl Sulfoxide 3 Identification ABP Dimethyl Sulfoxide 4 Identification BBP Dimethyl Sulfoxide 5 Identification CBP Dimethyl Sulfoxide 6 Identification DBP Dimethyl Sulfoxide 7 AcidityBP Dimethyl Sulfoxide 8 Relative DensityBP Dimethyl Sulfoxide 9 Refractive IndexBP Dimethyl Sulfoxide 10 Freezing PointBP Dimethyl Sulfoxide 11 AbsorbanceBP Dimethyl Sulfoxide 12 Related SubstancesBP Dimethyl Sulfoxide 12 TotalBP Dimethyl Sulfoxide WaterBP Dimeticone 1 AppearanceBP Dimeticone 2 SolubilityBP Dimeticone 3 Identification ABP Dimeticone 4 Identification BBP Dimeticone 5 Identification CBP Dimeticone 6 Identification DBP Dimeticone 7 AcidityBP Dimeticone 8 ViscosityBP Dimeticone 9 Mineral oilsBP Dimeticone 10 Phenylated compoundsBP Dimeticone 11 Heavy MetalsBP Dimeticone 12 Volatile matter

Tot6al of impurities other than Ethanol and 2-methylbut-2-ene

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 36 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Dipotassium Hydrogen Phosphate 1 Appearance

BP Dipotassium Hydrogen Phosphate 2 SolubilityBP Dipotassium Hydrogen Phosphate 3 Identification ABP Dipotassium Hydrogen Phosphate 4 Identification BBP Dipotassium Hydrogen Phosphate 5 Identification CBP Dipotassium Hydrogen Phosphate 6 Appearance of solutionBP Dipotassium Hydrogen Phosphate 7 Reducing SubstancesBP Dipotassium Hydrogen Phosphate 8 Monopotassium phosphateBP Dipotassium Hydrogen Phosphate 9 ChloridesBP Dipotassium Hydrogen Phosphate 10 SulfatesBP Dipotassium Hydrogen Phosphate 11 IronBP Dipotassium Hydrogen Phosphate 12 Heavy MetalsBP Dipotassium Hydrogen Phosphate 13 SodiumBP Dipotassium Hydrogen Phosphate 14 Loss on DryingBP Dipotassium Hydrogen Phosphate 15 AssayBP Disintegration DisintegrationBP Disodium Edetate 1 AppearanceBP Disodium Edetate 2 SolubilityBP Disodium Edetate 3 Identification ABP Disodium Edetate 4 Identification BBP Disodium Edetate 5 Identification CBP Disodium Edetate 6 Identification DBP Disodium Edetate 7 Appearance of solutionBP Disodium Edetate 8 pHBP Disodium Edetate 10 IronBP Disodium Edetate 11 Heavy MetalsBP Disodium Edetate 12 AssayBP Disodium Edetate (Impurity A) 9 Impurity ABP Dobutamine Infusion 1 Identification ABP Dobutamine Infusion 2 AssayBP Docusate Sodium 1 AppearanceBP Docusate Sodium 2 SolubilityBP Docusate Sodium 3 Identification ABP Docusate Sodium 4 Identification BBP Docusate Sodium 5 AlkalinityBP Docusate Sodium 6 Related non-ionic substancesBP Docusate Sodium 7 ChlorideBP Docusate Sodium 8 Sodium SulfateBP Docusate Sodium 9 Heavy MetalsBP Docusate Sodium 10 WaterBP Docusate Sodium 11 AssayBP Dog Rose 1 Identification CBP Dog Rose 2 Foreign MatterBP Dog Rose 3 Loss on dryingBP Dog Rose 4 Total AshBP Dog Rose 5 AssayBP Dog Rose 5 Results ABP Dog Rose 5 Results BBP Doxycycline Monohydrate 1 AppearanceBP Doxycycline Monohydrate 2 SolubilityBP Doxycycline Monohydrate 3 Identification BBP Doxycycline Monohydrate 4 Identification C

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 37 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Doxycycline Monohydrate 5 pH

BP Doxycycline Monohydrate 6 Specific Optical RotationBP Doxycycline Monohydrate 7 Specific absorbanceBP Doxycycline Monohydrate 8 Light ImpuritiesBP Doxycycline Monohydrate 9 Heavy MetalsBP Doxycycline Monohydrate 10 WaterBP Doxycycline Monohydrate 11 Sulfated AshBP Dried Magnesium Sulfate 1 CharactersBP Dried Magnesium Sulfate 2 IdentificationBP Dried Magnesium Sulfate 3 Acidity or alkalinityBP Dried Magnesium Sulfate 4 Heavy MetalsBP Dried Magnesium Sulfate 5 IronBP Dried Magnesium Sulfate 6 ChloridesBP Dried Magnesium Sulfate 7 Insoluble MatterBP Dried Magnesium Sulfate 8 AssayBP Dry Residue of Extracts 1 Residue on evaporationBP Dry Residue of Extracts 2 Dry Residue of ExtractsBP Echinacea Angustifolia Root 1 Identification CBP Echinacea Angustifolia Root 3 Foreign MatterBP Echinacea Angustifolia Root 4 Echinacea Purpurea (TLC)BP Echinacea Angustifolia Root 5 Loss on DryingBP Echinacea Angustifolia Root 6 Total AshBP Echinacea Angustifolia Root 7 Ash insoluble in hydrochloric acid

2 Identification D

8 AssayBP Edetic Acid 1 AppearanceBP Edetic Acid 2 SolubilityBP Edetic Acid 3 Identification ABP Edetic Acid 4 Identification BBP Edetic Acid 5 Identification CBP Edetic Acid 6 Appearance of solutionBP Edetic Acid 7 ChloridesBP Edetic Acid 8 IronBP Edetic Acid 9 Heavy MetalsBP Edetic Acid 10 Sulfated AshBP Edetic Acid 11 AssayBP Erythritol 1 AppearanceBP Erythritol 2 SolubilityBP Erythritol 3 Identification ABP Erythritol 4 Identification BBP Erythritol 5 Appearance of SolutionBP Erythritol 6 ConductivityBP Erythritol 8 Water

7 Related Substances

7 Any impurity

7 Total impurities

9 Assay

BP Echinacea Angustifolia Root (ID D and/or Assay)BP Echinacea Angustifolia Root (ID D and/or Assay)

BP Erythritol (Assay and/or Related substances)BP Erythritol (Assay and/or Related substances)BP Erythritol (Assay and/or Related substances)BP Erythritol (Assay and/or Related substances)

Page 38: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 38 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Essential Oils in Herbal Drugs Essential Oil Content

BP Ethanol 1 AppearanceBP Ethanol 2 SolubilityBP Ethanol 3 Boiling PointBP Ethanol 4 Identification ABP Ethanol 5 Identification BBP Ethanol 6 Identification CBP Ethanol 7 Identification DBP Ethanol 8 Appearance (Tests)BP Ethanol 9 Acidity or alkalinityBP Ethanol 10 Relative densityBP Ethanol 11 AbsorbanceBP Ethanol 12 Volatile ImpuritiesBP Ethanol 12 MethanolBP Ethanol 12 Acetaldehyde + AcetalBP Ethanol 12 BenzeneBP Ethanol 12 Total of Other ImpuritiesBP Ethanol 13 Residue on evaporationBP Ethanol 14 Content (From Relative Density)BP Ethanol (96 per cent) 1 AppearanceBP Ethanol (96 per cent) 2 SolubilityBP Ethanol (96 per cent) 3 Boiling PointBP Ethanol (96 per cent) 4 Identification ABP Ethanol (96 per cent) 5 Identification BBP Ethanol (96 per cent) 6 Identification CBP Ethanol (96 per cent) 7 Identification DBP Ethanol (96 per cent) 8 Appearance (Tests)BP Ethanol (96 per cent) 9 Acidity or alkalinityBP Ethanol (96 per cent) 10 Relative densityBP Ethanol (96 per cent) 11 AbsorbanceBP Ethanol (96 per cent) 13 Residue on evaporationBP Ethanol (96 per cent) 14 Content

12 Volatile impurities

12 Disregard limit

12 Acetaldehyde and acetal

12 Methanol

12 Total of other impurities

12 BenzeneBP Ethanol-soluble Extractive 1 Ethanol-soluble Extractive

8 Related Substances

8 Total

8 unspecified impurities

8 Impurity A

BP Ethanol (96 per cent) (Volatile impurities )BP Ethanol (96 per cent) (Volatile impurities )BP Ethanol (96 per cent) (Volatile impurities )BP Ethanol (96 per cent) (Volatile impurities )BP Ethanol (96 per cent) (Volatile impurities )BP Ethanol (96 per cent) (Volatile impurities )

BP Ethyl Hydroxybenzoate (Assay and/or Related substances)BP Ethyl Hydroxybenzoate (Assay and/or Related substances)BP Ethyl Hydroxybenzoate (Assay and/or Related substances)BP Ethyl Hydroxybenzoate (Assay and/or Related substances)

Page 39: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 39 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

10 AssayBP Ethyl Hydrozybenzoate 1 AppearanceBP Ethyl Hydrozybenzoate 2 SolubilityBP Ethyl Hydrozybenzoate 3 Identification ABP Ethyl Hydrozybenzoate 4 Identification BBP Ethyl Hydrozybenzoate 5 Identification CBP Ethyl Hydrozybenzoate 6 Appearance of solutionBP Ethyl Hydrozybenzoate 7 AcidityBP Ethyl Hydrozybenzoate 9 Sulphated AshBP Ethyl Oleate 1 AppearanceBP Ethyl Oleate 2 SolubilityBP Ethyl Oleate 3 Identification ABP Ethyl Oleate 4 Identification BBP Ethyl Oleate 5 Identification CBP Ethyl Oleate 6 Relative densityBP Ethyl Oleate 7 Acid ValueBP Ethyl Oleate 8 Iodine ValueBP Ethyl Oleate 9 Peroxide ValueBP Ethyl Oleate 10 Saponification ValueBP Ethyl Oleate 11 Oleic acidBP Ethyl Oleate 12 WaterBP Ethyl Oleate 13 Total AshBP Ethylene Glycol Monopalmitostearate 1 AppearanceBP Ethylene Glycol Monopalmitostearate 2 SolubilityBP Ethylene Glycol Monopalmitostearate 3 Identification ABP Ethylene Glycol Monopalmitostearate 5 Melting pointBP Ethylene Glycol Monopalmitostearate 6 Acid ValueBP Ethylene Glycol Monopalmitostearate 7 Iodine ValueBP Ethylene Glycol Monopalmitostearate 8 Saponification ValueBP Ethylene Glycol Monopalmitostearate 10 Total ash

4 Identification B

9 Composition of fatty acids

9

9 Stearic acidBP Ethylenediamine 1 AppearanceBP Ethylenediamine 2 SolubilityBP Ethylenediamine 3 Identification ABP Ethylenediamine 4 Identification BBP Ethylenediamine 5 Identification CBP Ethylenediamine 6 Appearance of solutionBP Ethylenediamine 7 CarbonatesBP Ethylenediamine 8 ChloridesBP Ethylenediamine 9 Ammonia and Other BasesBP Ethylenediamine 10 IronBP Ethylenediamine 11 Heavy MetalsBP Ethylenediamine 12 Residue on evaporationBP Ethylenediamine 13 AssayBP Eucalyptus Oil 1 Appearance

BP Ethyl Hydroxybenzoate (Assay and/or Related substances)

BP Ethylene Glycol Monopalmitostearate (ID B and/or composition of fatty acids)BP Ethylene Glycol Monopalmitostearate (ID B and/or composition of fatty acids)BP Ethylene Glycol Monopalmitostearate (ID B and/or composition of fatty acids)

Sum of contents of palmitic acid and stearic acid

BP Ethylene Glycol Monopalmitostearate (ID B and/or composition of fatty acids)

Page 40: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 40 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Eucalyptus Oil 2 Odour

BP Eucalyptus Oil 3 Identification ABP Eucalyptus Oil 5 Relative densityBP Eucalyptus Oil 6 Refractive indexBP Eucalyptus Oil 7 Optical rotationBP Eucalyptus Oil 8 Solubility in alcoholBP Eucalyptus Oil 9 Aldehydes

4 Identification B

10 Chromatographic Profile

10 Limonene

10 Sabinene

10 a-Pinene

10 a-Phellandrene

10 1.8-Cineole

10 Camphor

10 b-Pinene

Extractable VolumeBP Ferrous Fumarate 1 AppearanceBP Ferrous Fumarate 2 SolubilityBP Ferrous Fumarate 3 Identification ABP Ferrous Fumarate 4 Identification BBP Ferrous Fumarate 5 Identification CBP Ferrous Fumarate 6 SulfatesBP Ferrous Fumarate 7 Loss on dryingBP Ferrous Fumarate 8 AssayBP Ferulic Acid 1 AssayBP Fish Oil, Rich in Omega-3-Acids 1 AppearanceBP Fish Oil, Rich in Omega-3-Acids 2 SolubilityBP Fish Oil, Rich in Omega-3-Acids 5 Appearance (Tests)BP Fish Oil, Rich in Omega-3-Acids 6 AbsorbanceBP Fish Oil, Rich in Omega-3-Acids 7 Acid ValueBP Fish Oil, Rich in Omega-3-Acids 8 Anisidine ValueBP Fish Oil, Rich in Omega-3-Acids 9 Peroxide ValueBP Fish Oil, Rich in Omega-3-Acids 10 Unsaponifiable matterBP Fish Oil, Rich in Omega-3-Acids 11 Stearin

3 Identification A

4 Identification B

12 EPA and DHA(as Triglycerides)

12 DHA (as Triglycerides)

BP Eucalyptus Oil (Chromatographic profile and/or ID B )BP Eucalyptus Oil (Chromatographic profile and/or ID B )BP Eucalyptus Oil (Chromatographic profile and/or ID B )BP Eucalyptus Oil (Chromatographic profile and/or ID B )BP Eucalyptus Oil (Chromatographic profile and/or ID B )BP Eucalyptus Oil (Chromatographic profile and/or ID B )BP Eucalyptus Oil (Chromatographic profile and/or ID B )BP Eucalyptus Oil (Chromatographic profile and/or ID B )BP Eucalyptus Oil (Chromatographic profile and/or ID B )BP Extractable Volume of Parenteral Preparations

BP Fish Oil, Rich in Omega-3-Acids (EPA and/or DHA and/or Total omega-3)BP Fish Oil, Rich in Omega-3-Acids (EPA and/or DHA and/or Total omega-3)BP Fish Oil, Rich in Omega-3-Acids (EPA and/or DHA and/or Total omega-3)BP Fish Oil, Rich in Omega-3-Acids (EPA and/or DHA and/or Total omega-3)

Page 41: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 41 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

12 EPA (as Triglycerides)

13 Total omega-3 acids (as Triglycerides)BP Folic Acid 1 AppearanceBP Folic Acid 2 SolubilityBP Folic Acid 3 Identification ABP Folic Acid 5 Identification CBP Folic Acid 7 WaterBP Folic Acid 8 Sulfated Ash

4 Identification B

6 Related Substances

6 Impurity A

6 Impurity D

6 Any other impurity

6 Total of other impurities

9 Assay (anhydrous substance)BP Folic Acid Tablets 1 IdentificationBP Folic Acid Tablets (Hydrolysis products) 2 Hydrolysis productsBP Folic Acid Tablets (Hydrolysis products) 2 LimitsBP Formaldehyde Solution 1 AppearanceBP Formaldehyde Solution 2 SolubilityBP Formaldehyde Solution 3 Identification ABP Formaldehyde Solution 4 Identification BBP Formaldehyde Solution 5 Identification CBP Formaldehyde Solution 6 Identification DBP Formaldehyde Solution 7 Appearance of solutionBP Formaldehyde Solution 8 AcidityBP Formaldehyde Solution 9 MethanolBP Formaldehyde Solution 10 Sulfated AshBP Formaldehyde Solution 11 AssayBP Formic Acid 1 AppearanceBP Formic Acid 2 AssayBP Fructose 1 AppearanceBP Fructose 2 SolubilityBP Fructose 3 Identification ABP Fructose 4 Identification BBP Fructose 5 Identification CBP Fructose 6 Identification DBP Fructose 7 Appearance of solutionBP Fructose 8 Acidity or alkalinityBP Fructose 9 Specific Optical RotationBP Fructose 10 Foreign sugarsBP Fructose 11BP Fructose 12 Barium

BP Fish Oil, Rich in Omega-3-Acids (EPA and/or DHA and/or Total omega-3)BP Fish Oil, Rich in Omega-3-Acids (EPA and/or DHA and/or Total omega-3)

BP Folic Acid (ID B and/or Assay and/or Related substances)BP Folic Acid (ID B and/or Assay and/or Related substances)BP Folic Acid (ID B and/or Assay and/or Related substances)BP Folic Acid (ID B and/or Assay and/or Related substances)BP Folic Acid (ID B and/or Assay and/or Related substances)BP Folic Acid (ID B and/or Assay and/or Related substances)BP Folic Acid (ID B and/or Assay and/or Related substances)

5-Hydroxymethylfurfural and related compounds

Page 42: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 42 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Fructose 13 Water

BP Fructose 14 Sulfated AshBP Gelatin 1 AppearanceBP Gelatin 2 SolubilityBP Gelatin 3 Identification ABP Gelatin 4 Identification BBP Gelatin 5 pHBP Gelatin 6 ConductivityBP Gelatin 7 Sulfur DioxideBP Gelatin 8 PeroxidesBP Gelatin 9 Loss on DryingBP Ginger 1 CharactersBP Ginger 2 Identification CBP Ginger 3 WaterBP Ginger 4 Total AshBP Ginger 5 AssayBP Ginseng 1 Identification CBP Ginseng 2 Loss on DryingBP Ginseng 3 Total AshBP Ginseng 4 Ash insoluble in hydrochloric acidBP Glass Containers for Pharmaceutical Use 1 Weight LossBP Glass Containers for Pharmaceutical Use 2BP Glass Containers for Pharmaceutical Use 3 Hydrolytic ResistanceBP Glucose 1 AppearanceBP Glucose 2 SolubilityBP Glucose 3 Identification A (optical rotation)BP Glucose 4 Identification BBP Glucose 5 Identification CBP Glucose 6 Appearance of solutionBP Glucose 7 Acidity or alkalinityBP Glucose 8 Specific Optical RotationBP Glucose 9 Foreign sugars, soluble starch, dextrinsBP Glucose 10 SulfitesBP Glucose 11 ChloridesBP Glucose 12 SulfatesBP Glucose 14 BariumBP Glucose 15 CalciumBP Glucose 17 WaterBP Glucose 18 Sulfated AshBP Glutamic Acid 1 CharactersBP Glutamic Acid 2 Identification ABP Glutamic Acid 3 Identification BBP Glutamic Acid 4 Identification CBP Glutamic Acid 5 Identification DBP Glutamic Acid 6 Appearance of SolutionBP Glutamic Acid 7 Specific Optical RotationBP Glutamic Acid 8 Ninhydrin Positive SubstancesBP Glutamic Acid 9 ChloridesBP Glutamic Acid 10 SulfatesBP Glutamic Acid 11 AmmoniaBP Glutamic Acid 12 Iron

Spectral transmission for coloured glass containers

Page 43: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 43 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Glutamic Acid 13 Heavy Metals

BP Glutamic Acid 14 Loss on DryingBP Glutamic Acid 15 Sulfated AshBP Glutamic Acid 16 AssayBP Glutathione 1 AppearanceBP Glutathione 2 SolubilityBP Glutathione 3 Identification ABP Glutathione 4 Identification BBP Glutathione 5 Appearance of solutionBP Glutathione 6 Specific Optical RotationBP Glutathione 7 ChloridesBP Glutathione 8 SulfatesBP Glutathione 9 AmmoniumBP Glutathione 10 IronBP Glutathione 11 Heavy MetalsBP Glutathione 12 Loss on DryingBP Glutathione 13 Sulfated AshBP Glutathione 14 Assay (dried substance)BP Glycerol 1 AspectBP Glycerol 2 SolubilityBP Glycerol 3 Identification ABP Glycerol 4 Identification BBP Glycerol 5 Identification CBP Glycerol 6 Identification DBP Glycerol 7 Appearance of solutionBP Glycerol 8 Acidity or alkalinityBP Glycerol 9 Refractive indexBP Glycerol 10 AldehydesBP Glycerol 11 EstersBP Glycerol 13 Halogenated compoundsBP Glycerol 14 SugarBP Glycerol 15 ChloridesBP Glycerol 16 Heavy MetalsBP Glycerol 17 WaterBP Glycerol 18 Sulfated AshBP Glycerol 19 Assay

12 Impurity A & Related Substances

12 Disregard limit

12 Impurity A

12 Total

12 Any other impurityBP Glycerol Dibehenate 1 AppearanceBP Glycerol Dibehenate 2 SolubilityBP Glycerol Dibehenate 3 Identification ABP Glycerol Dibehenate 4 Identification BBP Glycerol Dibehenate 5 Acid ValueBP Glycerol Dibehenate 6 Iodine ValueBP Glycerol Dibehenate 7 Saponification Value

BP Glycerol (Impurity A & Related substances)BP Glycerol (Impurity A & Related substances)BP Glycerol (Impurity A & Related substances)BP Glycerol (Impurity A & Related substances)BP Glycerol (Impurity A & Related substances)

Page 44: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 44 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Glycerol Dibehenate 8 Composition of fatty acids

BP Glycerol Dibehenate 8 Erucic acidBP Glycerol Dibehenate 8 Palmitic acidBP Glycerol Dibehenate 8 Stearic acidBP Glycerol Dibehenate 8 Arachidic acidBP Glycerol Dibehenate 8 Behenic acidBP Glycerol Dibehenate 8 Lignoceric acidBP Glycerol Dibehenate 9 WaterBP Glycerol Dibehenate 10 Total AshBP Glycerol Mono-oleate 1 AppearanceBP Glycerol Mono-oleate 2 SolubilityBP Glycerol Mono-oleate 3 Identification ABP Glycerol Mono-oleate 4 Identification BBP Glycerol Mono-oleate 5 Acid ValueBP Glycerol Mono-oleate 6 Iodine ValueBP Glycerol Mono-oleate 7 Peroxide ValueBP Glycerol Mono-oleate 8 Saponification ValueBP Glycerol Mono-oleate 9 Composition of fatty acidsBP Glycerol Mono-oleate 9 Palmitic acidBP Glycerol Mono-oleate 9 Stearic AcidBP Glycerol Mono-oleate 9 Oleic AcidBP Glycerol Mono-oleate 9 Linoleic AcidBP Glycerol Mono-oleate 9 Linolenic acidBP Glycerol Mono-oleate 9 Arichidic AcidBP Glycerol Mono-oleate 9 EicosenoicBP Glycerol Mono-oleate 10 WaterBP Glycerol Mono-oleate 11 Total AshBP Glycerol Monostearate 40-55 1 AppearanceBP Glycerol Monostearate 40-55 2 SolubilityBP Glycerol Monostearate 40-55 3 Identification ABP Glycerol Monostearate 40-55 4 Identification BBP Glycerol Monostearate 40-55 6 Acid ValueBP Glycerol Monostearate 40-55 7 Iodine ValueBP Glycerol Monostearate 40-55 8 Saponification ValueBP Glycerol Monostearate 40-55 10 WaterBP Glycerol Monostearate 40-55 11 Total Ash

5 Identification C

9 Composition of fatty acids

9 Stearic acid

9BP Guaiacol 1 AppearanceBP Guaiacol 2 SolubilityBP Guaiacol 3 Melting pointBP Guaiacol 4 Identification ABP Guaiacol 5 Identification BBP Guaiacol 6 Appearance of solutionBP Guaiacol 7 Acidity or alkalinityBP Guaiacol 9 WaterBP Guaiacol (Impurity A and/or Assay) 8 Impurity A

BP Glycerol Monostearate 40-55 (ID C and/or Composition of fatty acids)BP Glycerol Monostearate 40-55 (ID C and/or Composition of fatty acids)BP Glycerol Monostearate 40-55 (ID C and/or Composition of fatty acids)BP Glycerol Monostearate 40-55 (ID C and/or Composition of fatty acids)

Sum of the contents of palmitic and stearic acids

Page 45: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 45 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Guaiacol (Impurity A and/or Assay) 10 Assay (anhydrous substance)

BP Hard Paraffin 1 AppearanceBP Hard Paraffin 2 SolubilityBP Hard Paraffin 3 Identification ABP Hard Paraffin 4 Identification BBP Hard Paraffin 5 Identification CBP Hard Paraffin 6 Acidity or alkalinityBP Hard Paraffin 7 Polycyclic aromatic hydrocarbonsBP Hard Paraffin 8 SulfatesBP Hawthorn Leaf and Flower Dry Extract Total FlavonoidsBP Heavy Magnesium Carbonate 1 AppearanceBP Heavy Magnesium Carbonate 2 SolubilityBP Heavy Magnesium Carbonate 3 Identification ABP Heavy Magnesium Carbonate 4 Identification BBP Heavy Magnesium Carbonate 5 Identification CBP Heavy Magnesium Carbonate 6 Appearance of solutionBP Heavy Magnesium Carbonate 7 Soluble SubstancesBP Heavy Magnesium Carbonate 8 Substances insoluble in acetic acidBP Heavy Magnesium Carbonate 9 ChloridesBP Heavy Magnesium Carbonate 10 SulfatesBP Heavy Magnesium Carbonate 11 CalciumBP Heavy Magnesium Carbonate 12 IronBP Heavy Magnesium Carbonate 13 Heavy MetalsBP Heavy Magnesium Carbonate 14 AssayBP Heavy Magnesium Oxide 1 AppearanceBP Heavy Magnesium Oxide 2 SolubilityBP Heavy Magnesium Oxide 3 Identification ABP Heavy Magnesium Oxide 4 Identification BBP Heavy Magnesium Oxide 5 Identification CBP Heavy Magnesium Oxide 6 Appearance of solutionBP Heavy Magnesium Oxide 7 Soluble SubstancesBP Heavy Magnesium Oxide 8 Substances insoluble in acetic acidBP Heavy Magnesium Oxide 9 ChloridesBP Heavy Magnesium Oxide 10 SulfatesBP Heavy Magnesium Oxide 12 CalciumBP Heavy Magnesium Oxide 13 IronBP Heavy Magnesium Oxide 14 Heavy MetalsBP Heavy Magnesium Oxide 15 Loss on ignitionBP Heavy Magnesium Oxide 16 AssayBP Heavy Magnesium Oxide 17 Particle-size distributionBP Heavy Magnesium Oxide 18 Bulk and tapped densityBP Hexamidine Isetionate 1 AppearanceBP Hexamidine Isetionate 2 SolubilityBP Hexamidine Isetionate 3 Identification ABP Hexamidine Isetionate 4 Identification BBP Hexamidine Isetionate 5 Appearance of solutionBP Hexamidine Isetionate 6 Acidity or alkalinityBP Hexamidine Isetionate 7 Loss on dryingBP Hexamidine Isetionate 8 Sulfated AshBP Hexamidine Isetionate 9 AssayBP Hexane 1 AppearanceBP Hexane 2 Relative density

Page 46: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 46 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Highly Purified Water 1 Total Organic Carbon

BP Highly Purified Water 2 ConductivityBP Highly Purified Water 3 AppearanceBP Highly Purified Water 4 NitratesBP Highly Purified Water 5 AluminiumBP Histidine 1 AppearanceBP Histidine 2 SolubilityBP Histidine 3 Identification ABP Histidine 4 Identification BBP Histidine 5 Identification CBP Histidine 6 Identification DBP Histidine 7 Appearance of SolutionBP Histidine 8 Specific Optical RotationBP Histidine 9 Ninhydrin Positive SubstancesBP Histidine 10 ChloridesBP Histidine 11 SulfatesBP Histidine 12 AmmoniaBP Histidine 13 IronBP Histidine 14 Heavy MetalsBP Histidine 15 Loss on DryingBP Histidine 16 Sulfated AshBP Histidine 17 AssayBP Honey 1 AppearanceBP Honey 2 IdentificationBP Honey 3 Refractive indexBP Honey 4 ConductivityBP Honey 5 Optical rotationBP Honey 6 5-HydroxymethylfurfuralBP Honey 7 ChloridesBP Honey 8 SulfatesBP Hydrated Sodium Glycerophosphate 1 AppearanceBP Hydrated Sodium Glycerophosphate 2 solubilityBP Hydrated Sodium Glycerophosphate 3 Identification ABP Hydrated Sodium Glycerophosphate 4 Identification BBP Hydrated Sodium Glycerophosphate 5 Identification CBP Hydrated Sodium Glycerophosphate 6 Appearance of SolutionBP Hydrated Sodium Glycerophosphate 7 AlkalinityBP Hydrated Sodium Glycerophosphate 8 Glycerol and ethanol soluble substancesBP Hydrated Sodium Glycerophosphate 9 ChloridesBP Hydrated Sodium Glycerophosphate 10 PhosphatesBP Hydrated Sodium Glycerophosphate 11 SulfatesBP Hydrated Sodium Glycerophosphate 12 IronBP Hydrated Sodium Glycerophosphate 13 heavy MetalsBP Hydrated Sodium Glycerophosphate 14 WaterBP Hydrated Sodium Glycerophosphate 15 AssayBP Hydrocortisone 1 Appearance BP Hydrocortisone 2 SolubilityBP Hydrocortisone 3 Identification ABP Hydrocortisone 4 Identification BBP Hydrocortisone 5 Identification CBP Hydrocortisone 6 Identification DBP Hydrocortisone 7 Specific Optical Rotation

Page 47: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 47 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Hydrocortisone 8 Related Substances

BP Hydrocortisone 8 Impurities C, D, E, IBP Hydrocortisone 8 Impurity GBP Hydrocortisone 8 Impurity FBP Hydrocortisone 8 Impurities A, BBP Hydrocortisone 8 Impurities H, NBP Hydrocortisone 8 Unspecified ImpuritiesBP Hydrocortisone 8 TotalBP Hydrocortisone 9 Loss on DryinngBP Hydrocortisone 10 AssayBP Hydrocortisone Cream 1 Identification ABP Hydrogen Peroxide Solution (30%) 1 AppearanceBP Hydrogen Peroxide Solution (30%) 2 Identification ABP Hydrogen Peroxide Solution (30%) 3 Identification BBP Hydrogen Peroxide Solution (30%) 4 Identification CBP Hydrogen Peroxide Solution (30%) 5 AcidityBP Hydrogen Peroxide Solution (30%) 6 Organic stabilisersBP Hydrogen Peroxide Solution (30%) 7 Non-Volatile ResidueBP Hydrogen Peroxide Solution (30%) 8 AssayBP Hydrogenated Castor Oil 1 AppearanceBP Hydrogenated Castor Oil 2 SolubilityBP Hydrogenated Castor Oil 3 Identification ABP Hydrogenated Castor Oil 4 Identification BBP Hydrogenated Castor Oil 5 Identification CBP Hydrogenated Castor Oil 6 Acid ValueBP Hydrogenated Castor Oil 7 Hydroxyl ValueBP Hydrogenated Castor Oil 8 Iodine ValueBP Hydrogenated Castor Oil 9 Alkaline ImpuritiesBP Hydrogenated Castor Oil 10 Composition of fatty acidsBP Hydrogenated Castor Oil 10 Any other fatty acidBP Hydrogenated Castor Oil 10 12-hydroxystearic acidBP Hydrogenated Castor Oil 10 12-oxostearic acidBP Hydrogenated Castor Oil 10 Stearic acidBP Hydrogenated Castor Oil 10 Palmitic acidBP Hydrogenated Castor Oil 10 Arachidic acidBP Hydrogenated Polyoxyl Castor Oil 1 AppearanceBP Hydrogenated Polyoxyl Castor Oil 2 SolubilityBP Hydrogenated Polyoxyl Castor Oil 3 Identification ABP Hydrogenated Polyoxyl Castor Oil 4 Identification BBP Hydrogenated Polyoxyl Castor Oil 5 Identification CBP Hydrogenated Polyoxyl Castor Oil 6 Identification DBP Hydrogenated Polyoxyl Castor Oil 7 Appearance of solutionBP Hydrogenated Polyoxyl Castor Oil 8 AlkalinityBP Hydrogenated Polyoxyl Castor Oil 9 Acid ValueBP Hydrogenated Polyoxyl Castor Oil 10 Hydroxyl ValueBP Hydrogenated Polyoxyl Castor Oil 11 Iodine ValueBP Hydrogenated Polyoxyl Castor Oil 12 Saponification ValueBP Hydrogenated Polyoxyl Castor Oil 14 Heavy MetalsBP Hydrogenated Polyoxyl Castor Oil 15 WaterBP Hydrogenated Polyoxyl Castor Oil 16 Total Ash

13 Residual ethylene oxide and dioxanBP Hydrogenated Polyoxyl Castor Oil (Residual impurities)

Page 48: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 48 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Hydrogenated Vegetable Oil 1 Characteristics

BP Hydrogenated Vegetable Oil 2 IdentificationBP Hydrogenated Vegetable Oil 3 Melting pointBP Hydrogenated Vegetable Oil 4 Acid ValueBP Hydrogenated Vegetable Oil 5 Iodine ValueBP Hydrogenated Vegetable Oil 6 Saponification ValueBP Hydrogenated Vegetable Oil 7 Unsaponifiable matterBP Hydrogenated Vegetable Oil 8 Heavy MetalsBP Hydrogenated Vegetable Oil 9 Loss on DryingBP Hydroxyethylcellulose 1 AppearanceBP Hydroxyethylcellulose 2 SolubilityBP Hydroxyethylcellulose 3 Identification ABP Hydroxyethylcellulose 4 Identification BBP Hydroxyethylcellulose 5 Identification CBP Hydroxyethylcellulose 6 Identification DBP Hydroxyethylcellulose 7 pHBP Hydroxyethylcellulose 8 Apparent viscosityBP Hydroxyethylcellulose 9 ChloridesBP Hydroxyethylcellulose 10 NitratesBP Hydroxyethylcellulose 11 GlyoxalBP Hydroxyethylcellulose 14 Heavy MetalsBP Hydroxyethylcellulose 15 Loss on DryingBP Hydroxyethylcellulose 16 Sulfated Ash

12 Ethylene oxide

13 2-ChloroethanolBP Hydroxyl Value 1 Hydroxyl ValueBP Hydroxypropylcellulose 1 Appearance BP Hydroxypropylcellulose 2 solubilityBP Hydroxypropylcellulose 3 Identification ABP Hydroxypropylcellulose 4 Identification BBP Hydroxypropylcellulose 5 Identification CBP Hydroxypropylcellulose 6 Identification DBP Hydroxypropylcellulose 7 Identification EBP Hydroxypropylcellulose 8 Identification FBP Hydroxypropylcellulose 9 Appearance of SolutionBP Hydroxypropylcellulose 10 pHBP Hydroxypropylcellulose 11 Apparent ViscosityBP Hydroxypropylcellulose 12 SilicaBP Hydroxypropylcellulose 13 ChloridesBP Hydroxypropylcellulose 14 Heavy MetalsBP Hydroxypropylcellulose 15 Loss on DryingBP Hydroxypropylcellulose 16 Sulfated AshBP Hypromellose 1 AppearanceBP Hypromellose 2 SolubilityBP Hypromellose 3 Identification ABP Hypromellose 4 Identification BBP Hypromellose 5 Identification CBP Hypromellose 6 Identification DBP Hypromellose 7 Identification EBP Hypromellose 8 Appearance of solutionBP Hypromellose 9 pH

BP Hydroxyethylcellulose (Ethylene oxide and/or 2-chloroethanol)BP Hydroxyethylcellulose (Ethylene oxide and/or 2-chloroethanol)

Page 49: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 49 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Hypromellose 10 Heavy Metals

BP Hypromellose 11 Loss on dryingBP Hypromellose 12 Sulfated AshBP Hypromellose 13 Apparent viscosityBP Hypromellose 14 Degree of SubstitutionBP Ibuprofen 1 AppearanceBP Ibuprofen 2 SolubilityBP Ibuprofen 3 Identification ABP Ibuprofen 4 Identification BBP Ibuprofen 5 Identification CBP Ibuprofen 6 Identification DBP Ibuprofen 7 Appearance of solutionBP Ibuprofen 8 Optical rotationBP Ibuprofen 9 Related SubstancesBP Ibuprofen 9 unspecified impuritiesBP Ibuprofen 9 TotalBP Ibuprofen 9 Impurity BBP Ibuprofen 9 Impurity ABP Ibuprofen 9 Impurities A, J, NBP Ibuprofen 11 Heavy MetalsBP Ibuprofen 12 Loss on DryingBP Ibuprofen 13 Sulfated AshBP Ibuprofen 14 AssayBP Ibuprofen (Impurity F) 10 Impurity FBP Ibuprofen Oral Suspension 1 Identification ABP Ibuprofen Oral Suspension 2 Identification BBP Ibuprofen Oral Suspension 3 AssayBP Infrared Spectrophotometry FTIR (liquid as is)BP Infrared Spectrophotometry FTIR (solid)BP Inulin 1 CharactersBP Inulin 2 Identification ABP Inulin 3 Identification BBP Inulin 4 Identification CBP Inulin 5 AcidityBP Inulin 6 Clarity and color of solutionBP Inulin 7 Specific Optical RotationBP Inulin 8 CalciumBP Inulin 9 ChlorideBP Inulin 10 SulphateBP Inulin 11 OxalateBP Inulin 12 Reducing SugarsBP Inulin 13 Loss on dryingBP Inulin 14 Sulphated AshBP Iodinated Povidone 1 AppearanceBP Iodinated Povidone 2 SolubilityBP Iodinated Povidone 3 Identification ABP Iodinated Povidone 4 Identification BBP Iodinated Povidone 5 Identification CBP Iodinated Povidone 6 pHBP Iodinated Povidone 7 IodideBP Iodinated Povidone 8 Loss on dryingBP Iodinated Povidone 9 Sulfated Ash

Page 50: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 50 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Iodinated Povidone 10 Assay

BP Iodine 1 AppearanceBP Iodine 2 SolubilityBP Iodine 3 Identification ABP Iodine 4 Identification BBP Iodine 5 Bromides and chloridesBP Iodine 6 Non-Volatile substancesBP Iodine 7 AssayBP Iodine Value 1 Iodine ValueBP Isomalt 1 AppearanceBP Isomalt 2 SolubilityBP Isomalt 4 Identification BBP Isomalt 5 Identification CBP Isomalt 6 ConductivityBP Isomalt 7 Reducing SugarsBP Isomalt 9 Water

3 Identification A

8 Related Substances

8 Impurities B, C

8 Any other impurity

8 Total

10 AssayBP Isopropyl Alcohol 1 AppearanceBP Isopropyl Alcohol 2 SolubilityBP Isopropyl Alcohol 3 Identification ABP Isopropyl Alcohol 4 Identification BBP Isopropyl Alcohol 5 Identification CBP Isopropyl Alcohol 5 Identification CBP Isopropyl Alcohol 6 Appearance (Tests)BP Isopropyl Alcohol 7 Acidity or alkalinityBP Isopropyl Alcohol 8 AbsorbanceBP Isopropyl Alcohol 10 PeroxidesBP Isopropyl Alcohol 11 Non-Volatile substancesBP Isopropyl Alcohol 12 Water

9 Benzene and related substances

9 Benzene

9 Total impuritiesBP Isopropyl Myristate 1 AppearanceBP Isopropyl Myristate 2 SolubilityBP Isopropyl Myristate 3 Relative densityBP Isopropyl Myristate 4 Identification ABP Isopropyl Myristate 6 Identification CBP Isopropyl Myristate 7 Appearance of solutionBP Isopropyl Myristate 8 Refractive index

BP Isomalt (ID A and/or Assay and/or Related substances)BP Isomalt (ID A and/or Assay and/or Related substances)BP Isomalt (ID A and/or Assay and/or Related substances)BP Isomalt (ID A and/or Assay and/or Related substances)BP Isomalt (ID A and/or Assay and/or Related substances)BP Isomalt (ID A and/or Assay and/or Related substances)

BP Isopropyl Alcohol (Benzene & related substances)BP Isopropyl Alcohol (Benzene & related substances)BP Isopropyl Alcohol (Benzene & related substances)

Page 51: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 51 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Isopropyl Myristate 8 Viscosity

BP Isopropyl Myristate 10 Acid ValueBP Isopropyl Myristate 11 Iodine ValueBP Isopropyl Myristate 12 Saponification ValueBP Isopropyl Myristate 13 WaterBP Isopropyl Myristate 14 Total ash (2.4.16)BP Isopropyl Myristate (ID and/or Assay) 5 Identification BBP Isopropyl Myristate (ID and/or Assay) 15 AssayBP Isopropyl Palmitate 1 AppearanceBP Isopropyl Palmitate 2 SolubilityBP Isopropyl Palmitate 3 Relative densityBP Isopropyl Palmitate 4 Identification ABP Isopropyl Palmitate 6 Identification CBP Isopropyl Palmitate 7 Appearance of solutionBP Isopropyl Palmitate 8 Refractive indexBP Isopropyl Palmitate 9 ViscosityBP Isopropyl Palmitate 10 Acid ValueBP Isopropyl Palmitate 11 Iodine ValueBP Isopropyl Palmitate 12 Saponification ValueBP Isopropyl Palmitate 13 WaterBP Isopropyl Palmitate 14 Total AshBP Isopropyl Palmitate (ID B and/or Assay) 5 Identification BBP Isopropyl Palmitate (ID B and/or Assay) 15 AssayBP Juniper Oil 1 AppearanceBP Juniper Oil 2 Identification ABP Juniper Oil 4 Relative densityBP Juniper Oil 5 Refractive indexBP Juniper Oil 6 Optical rotationBP Juniper Oil 7 Peroxide ValueBP Juniper Oil 8 Fatty oils and resinified essential oils

3 Identification B

9 Chromatographic Profile

9 alpha-Pinene

9 beta-Pinene

9 alpha-Phellandrene

9 Terpinen-4-ol

9 beta-Caryophyllene

9 Sabinene

9 beta-Myrcene

9 Limonene

9 Bomyl acetateBP Kelp 1 Characters

BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)BP Juniper Oil (ID B and/or Chromatographic profile)

Page 52: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 52 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Kelp 2 Identification C

BP Kelp 3 Swelling indexBP Kelp 4 Loss on dryingBP Kelp 5 Total AshBP Kelp 6 Ash insoluble in hydrochloric acidBP Kelp 7 AssayBP Lactic Acid 1 Characters (Solubility and Solubility)BP Lactic Acid 2 Identification ABP Lactic Acid 3 Identification BBP Lactic Acid 4 Identification CBP Lactic Acid 5 Appearance (Tests)BP Lactic Acid 6 Ether - Insoluble substancesBP Lactic Acid 7 Sugar & Other Reducing SubstancesBP Lactic Acid 9 Citric, Oxalic & Phosphoric AcidBP Lactic Acid 10 SulfatesBP Lactic Acid 11 CalciumBP Lactic Acid 12 Heavy MetalsBP Lactic Acid 13 Sulfated AshBP Lactic Acid 14 AssayBP Lactose 1 AppearanceBP Lactose 2 SolubilityBP Lactose 3 Identification ABP Lactose 4 Identification BBP Lactose 5 Identification CBP Lactose 6 Identification DBP Lactose 7 Appearance of solutionBP Lactose 8 Acidity or alkalinityBP Lactose 9 Specific Optical RotationBP Lactose 10 AbsorbanceBP Lactose 11 Heavy MetalsBP Lactose 12 WaterBP Lactose 13 Sulfated AshBP Lavender Oil 1 AppearanceBP Lavender Oil 2 OdourBP Lavender Oil 3 Identification ABP Lavender Oil 5 Relative densityBP Lavender Oil 6 Refractive indexBP Lavender Oil 7 Optical rotationBP Lavender Oil 8 Acid Value

4 Identification B

9 Chromatographic Profile

9 lavandulol

9 Terpinen-4-ol

9 alpha - terpineol

9 Linalol

9 Limonene

BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)

Page 53: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 53 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

9 linalyl acetate

9 1,8- cineole

9 lavandulyl acetate

9 Camphor

9 3-octanoneBP Lemon Oil 1 AppearanceBP Lemon Oil 2 Identification ABP Lemon Oil 4 Relative densityBP Lemon Oil 5 Refractive indexBP Lemon Oil 6 Optical rotationBP Lemon Oil 7 AbsorbanceBP Lemon Oil 8 Fatty oils and resinified essential oilsBP Lemon Oil 10 Residue on Evaporation

3 Identification B

9 Chromatographic Profile

9 Geranyl acetate

9 Geranial

9 Neryl acetate

9 alpha-Terpineol

9 beta-Pinene

9 Sabinene

9 Limonene

9 gamma-Terpinene

9 beta-Caryophyllene

9 NeralBP Leucine 1 CharactersBP Leucine 2 Identification ABP Leucine 3 Identification BBP Leucine 4 Identification CBP Leucine 5 Appearance of solutionBP Leucine 6 Specific Optical RotationBP Leucine 7 Ninhydrin-positive substancesBP Leucine 8 ChloridesBP Leucine 9 SulfatesBP Leucine 10 IronBP Leucine 11 Heavy MetalsBP Leucine 12 Loss on drying

BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)BP Lavender Oil (ID B and/or chromatographic profile)

BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)BP Lemon Oil (ID B and/or Chromatographic profile)

Page 54: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 54 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Leucine 13 Sulfated Ash

BP Leucine 14 AssayBP Levamisole 1 AppearanceBP Levamisole 2 SolubilityBP Levamisole 3 Identification ABP Levamisole 4 Identification BBP Levamisole 5 Appearance of solutionBP Levamisole 6 Specific Optical RotationBP Levamisole 7 Related SubstancesBP Levamisole 7 Impurities A, B, C, D, E BP Levamisole 7 Any other ImpurityBP Levamisole 7 TotalBP Levamisole 8 WaterBP Levamisole 9 Sulfated AshBP Levamisole 10 Assay (anhydrous substance)BP Levamisole Hydrochloride 1 AppearanceBP Levamisole Hydrochloride 2 SolubilityBP Levamisole Hydrochloride 3 Identification ABP Levamisole Hydrochloride 4 Identification BBP Levamisole Hydrochloride 5 Identification CBP Levamisole Hydrochloride 6 Appearance of solutionBP Levamisole Hydrochloride 7 pHBP Levamisole Hydrochloride 8 Specific Optical RotationBP Levamisole Hydrochloride 9 Related SubstancesBP Levamisole Hydrochloride 9 Impurities A, B, C, D, E BP Levamisole Hydrochloride 9 Unspecified ImpuritiesBP Levamisole Hydrochloride 9 TotalBP Levamisole Hydrochloride 10 Heavy MetalsBP Levamisole Hydrochloride 11 Loss on DryingBP Levamisole Hydrochloride 12 Sulfated AshBP Levamisole Hydrochloride 13 Assay (dried basis)BP Levocarnitine 1 Appearance BP Levocarnitine 2 SolubilityBP Levocarnitine 3BP Levocarnitine 4 Identification B (FTIR)BP Levocarnitine 5 Identification CBP Levocarnitine 6 Appearance of SolutionBP Levocarnitine 7 pHBP Levocarnitine 8 Specific Optical RotationBP Levocarnitine 9 Related SubstancesBP Levocarnitine 9 Impurity ABP Levocarnitine 9 Unspecified ImpuritiesBP Levocarnitine 10 ChloridesBP Levocarnitine 11 SulfatesBP Levocarnitine 12 Heavy MetalsBP Levocarnitine 13 WaterBP Levocarnitine 14 Sulfated AshBP Levocarnitine 15 AssayBP Levomenthol 1 AppearanceBP Levomenthol 2 SolubilityBP Levomenthol 3 Melting pointBP Levomenthol 4 Identification A

Identification A (Specific Optical Rotation)

Page 55: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 55 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Levomenthol 5 Identification B

BP Levomenthol 7 Identification DBP Levomenthol 8 Appearance of solutionBP Levomenthol 9 Acidity or alkalinityBP Levomenthol 10 Specific Optical RotationBP Levomenthol 12 Residue on evaporation

6 Identification C

11 Related Substances

11 Disregard limit

11 TotalBP Lidocaine Hydrochloride 1 AppearanceBP Lidocaine Hydrochloride 2 SolubilityBP Lidocaine Hydrochloride 3 Identification ABP Lidocaine Hydrochloride 4 Identification BBP Lidocaine Hydrochloride 5 Identification CBP Lidocaine Hydrochloride 6 Identification DBP Lidocaine Hydrochloride 7 Appearance of solutionBP Lidocaine Hydrochloride 8 pHBP Lidocaine Hydrochloride 10 Heavy MetalsBP Lidocaine Hydrochloride 11 WaterBP Lidocaine Hydrochloride 12 Sulfated AshBP Lidocaine Hydrochloride 13 Assay

9 Related Substances

9 Total

9 unspecified impurities

9 Impurity ABP Light Liquid Paraffin 1 AppearanceBP Light Liquid Paraffin 2 SolubilityBP Light Liquid Paraffin 3 Identification ABP Light Liquid Paraffin 4 Identification BBP Light Liquid Paraffin 5 Identification CBP Light Liquid Paraffin 6 Acidity or alkalinityBP Light Liquid Paraffin 7 Relative densityBP Light Liquid Paraffin 8 ViscosityBP Light Liquid Paraffin 9 Polycyclic aromatic hydrocarbonsBP Light Liquid Paraffin 10 Readily carbonisable substancesBP Light Liquid Paraffin 11 Solid paraffinsBP Limit Tests (Appendix VII) Limit Test - PhosphatesBP Limit Tests (Appendix VII) Limit Test - AmmoniumBP Limit Tests (Appendix VII) Limit Test - CalciumBP Limit Tests (Appendix VII) Limit Test - ChloridesBP Limit Tests (Appendix VII) Limit Test - IronBP Limit Tests (Appendix VII) Limit Test - SulfatesBP Limit Tests (Appendix VII) Limit Test - PotassiumBP Limit Tests (Appendix VII) Limit Test - Heavy Metals (Method A)

BP Levomenthol (ID C and/or Related substances)BP Levomenthol (ID C and/or Related substances)BP Levomenthol (ID C and/or Related substances)BP Levomenthol (ID C and/or Related substances)

BP Lidocaine Hydrochloride (Related substances)BP Lidocaine Hydrochloride (Related substances)BP Lidocaine Hydrochloride (Related substances)BP Lidocaine Hydrochloride (Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 56 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Limit Tests (Appendix VII) Limit Test - Heavy Metals (Method A)

BP Limit Tests (Appendix VII) Limit Test - Heavy Metals (Method E)BP Limit Tests (Appendix VII) Limit Test - Heavy Metals (Method H)BP Limit Tests (Appendix VII) Limit Test - Heavy Metals (Method B)BP Limit Tests (Appendix VII) Limit Test - AluminiumBP Limit Tests (Appendix VII) Limit Test - MagnesiumBP Limit Tests (Appendix VII)BP Limit Tests (Appendix VII) Limit Test - FluoridesBP Limit Tests (Appendix VII) Limit Test - Heavy Metals (Method C)BP Limit Tests (Appendix VII) Limit Test - Heavy Metals (Method D)BP Limit Tests (Appendix VII) Limit Test - Heavy Metals (Method F)BP Limit Tests (Appendix VII) Limit Test - Heavy Metals (Method G)BP Lincomycin Hydrochloride 1 CharactersBP Lincomycin Hydrochloride 2 Identification ABP Lincomycin Hydrochloride 3 Identification BBP Lincomycin Hydrochloride 6 Appearance of solutionBP Lincomycin Hydrochloride 7 pHBP Lincomycin Hydrochloride 8 Specific Optical RotationBP Lincomycin Hydrochloride 10 Heavy MetalsBP Lincomycin Hydrochloride 11 WaterBP Lincomycin Hydrochloride 12 Sulfated Ash

9 Related Substances

9 Impurity A

9

9 Impurity C

9 Unspecified Impurities

9 Total

13 Assay (anhydrous substance)

13 Lincomycin BBP Liquid Glucose 1 AppearanceBP Liquid Glucose 2 SolubilityBP Liquid Glucose 3 Identification ABP Liquid Glucose 4 Identification BBP Liquid Glucose 5 Identification CBP Liquid Glucose 6 Identification DBP Liquid Glucose 7 pHBP Liquid Glucose 8 Sulfur DioxideBP Liquid Glucose 9 Heavy MetalsBP Liquid Glucose 10 Loss on DryingBP Liquid Glucose 11 Sulfated AshBP Liquid Glucose 12 Dextrose equivalent (DE)BP Liquid Maltitol 1 AppearanceBP Liquid Maltitol 2 SolubilityBP Liquid Maltitol 4 Identification B

Limit Test - Magnesium and Alkaline-earth Metals

BP Lincomycin Hydrochloride (Lincomycin B and/or Assay)BP Lincomycin Hydrochloride (Lincomycin B and/or Assay)BP Lincomycin Hydrochloride (Lincomycin B and/or Assay)

Sum of the areas of the peaks due to Impurity B

BP Lincomycin Hydrochloride (Lincomycin B and/or Assay)BP Lincomycin Hydrochloride (Lincomycin B and/or Assay)BP Lincomycin Hydrochloride (Lincomycin B and/or Assay)BP Lincomycin Hydrochloride (Lincomycin B and/or Assay)BP Lincomycin Hydrochloride (Lincomycin B and/or Assay)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 57 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Liquid Maltitol 5 Identification C

BP Liquid Maltitol 6 Appearance of solutionBP Liquid Maltitol 7 ConductivityBP Liquid Maltitol 8 Reducing SugarsBP Liquid Maltitol 9 WaterBP Liquid Maltitol (ID A and/or Assay) 3 Identification ABP Liquid Maltitol (ID A and/or Assay) 10 AssayBP Liquid Maltitol (ID A and/or Assay) 10 D-MaltitolBP Liquid Maltitol (ID A and/or Assay) 10 D-SorbitolBP Liquid Paraffin 1 AppearanceBP Liquid Paraffin 2 SolubilityBP Liquid Paraffin 3 Identification ABP Liquid Paraffin 4 Identification BBP Liquid Paraffin 5 Identification CBP Liquid Paraffin 6 Acidity or alkalinityBP Liquid Paraffin 7 Relative densityBP Liquid Paraffin 8 ViscosityBP Liquid Paraffin 9 Polycyclic aromatic hydrocarbonsBP Liquid Paraffin 10 Readily carbonisable substancesBP Liquid Paraffin 11 Solid paraffinsBP Liquid Paraffin Oral Emulsion 1 AssayBP Liquid Sorbitol (Crystallising) 1 AppearanceBP Liquid Sorbitol (Crystallising) 2 Identification ABP Liquid Sorbitol (Crystallising) 3 Identification BBP Liquid Sorbitol (Crystallising) 4 Identification CBP Liquid Sorbitol (Crystallising) 5 Appearance of solutionBP Liquid Sorbitol (Crystallising) 6 ConductivityBP Liquid Sorbitol (Crystallising) 7 Reducing SugarsBP Liquid Sorbitol (Crystallising) 8 WaterBP Liquid Sorbitol (Crystallising) 9 AssayBP Liquid Sorbitol (Non-crystallising) 1 AppearanceBP Liquid Sorbitol (Non-crystallising) 3 Identification BBP Liquid Sorbitol (Non-crystallising) 4 Identification CBP Liquid Sorbitol (Non-crystallising) 5 Appearance of solutionBP Liquid Sorbitol (Non-crystallising) 6 ConductivityBP Liquid Sorbitol (Non-crystallising) 7 Reducing SugarsBP Liquid Sorbitol (Non-crystallising) 8 Reducing sugars after hydrolysisBP Liquid Sorbitol (Non-crystallising) 11 Water

2 Identification A

12 D-Sorbitol

12 D-Sorbitol (anhydrous substance)

12 D-Glucitol (anhydrous substance)

1 Appearance

2 Identification

3 Loss on dryingBP Liquorice Liquid Extract 1 Identification

BP Liquid Sorbitol (Non-crystallising) (ID A and/or Assay)BP Liquid Sorbitol (Non-crystallising) (ID A and/or Assay)BP Liquid Sorbitol (Non-crystallising) (ID A and/or Assay)BP Liquid Sorbitol (Non-crystallising) (ID A and/or Assay)BP Liquorice Dry Extract for Flavouring PurposesBP Liquorice Dry Extract for Flavouring PurposesBP Liquorice Dry Extract for Flavouring Purposes

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 58 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Liquorice Liquid Extract 2 Ethanol content

BP Liquorice Liquid Extract 3 AmmoniaBP Liquorice Liquid Extract 4 Dry residueBP Liquorice Liquid Extract 5 Relative densityBP Liquorice Liquid Extract 6 Ochratoxin ABP Loss on drying 1 Loss on dryingBP Loss on Ignition 1 Loss on ignitionBP Lysine Hydrochloride 1 AppearanceBP Lysine Hydrochloride 2 SolubilityBP Lysine Hydrochloride 3 Identification ABP Lysine Hydrochloride 4 Identification BBP Lysine Hydrochloride 5 Identification CBP Lysine Hydrochloride 6 Identification DBP Lysine Hydrochloride 7 Identification EBP Lysine Hydrochloride 8 Appearance of solutionBP Lysine Hydrochloride 9 Specific Optical RotationBP Lysine Hydrochloride 10 Ninhydrin-positive substancesBP Lysine Hydrochloride 11 SulfatesBP Lysine Hydrochloride 12 IronBP Lysine Hydrochloride 13 Heavy MetalsBP Lysine Hydrochloride 14 Loss on DryingBP Lysine Hydrochloride 15 Sulfated AshBP Lysine Hydrochloride 16 Assay (dried substance)BP Macrogol 30 Dipolyhydroxystearate 1 AppearanceBP Macrogol 30 Dipolyhydroxystearate 2 SolubilityBP Macrogol 30 Dipolyhydroxystearate 3 Melting pointBP Macrogol 30 Dipolyhydroxystearate 4 Identification ABP Macrogol 30 Dipolyhydroxystearate 5 Identification BBP Macrogol 30 Dipolyhydroxystearate 6 Identification CBP Macrogol 30 Dipolyhydroxystearate 7 Acid ValueBP Macrogol 30 Dipolyhydroxystearate 8 Hydroxyl ValueBP Macrogol 30 Dipolyhydroxystearate 9 Iodine ValueBP Macrogol 30 Dipolyhydroxystearate 10 Peroxide ValueBP Macrogol 30 Dipolyhydroxystearate 11 Saponification ValueBP Macrogol 30 Dipolyhydroxystearate 12 WaterBP Macrogol 30 Dipolyhydroxystearate 13 Sulfated AshBP Macrogol Cetostearyl Ether 1 AppearanceBP Macrogol Cetostearyl Ether 2 SolubilityBP Macrogol Cetostearyl Ether 3 Identification ABP Macrogol Cetostearyl Ether 4 Identification BBP Macrogol Cetostearyl Ether 5 Identification CBP Macrogol Cetostearyl Ether 6 Identification DBP Macrogol Cetostearyl Ether 7 Identification EBP Macrogol Cetostearyl Ether 8 Appearance of solutionBP Macrogol Cetostearyl Ether 9 AlkalinityBP Macrogol Cetostearyl Ether 10 Acid ValueBP Macrogol Cetostearyl Ether 11 Iodine ValueBP Macrogol Cetostearyl Ether 12 Saponification ValueBP Macrogol Cetostearyl Ether 13 Hydroxyl ValueBP Macrogol Cetostearyl Ether 15 WaterBP Macrogol Cetostearyl Ether 16 Total Ash

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 59 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

14 Ethylene oxide and dioxanBP Macrogol Glycerol Cocoates 1 AppearanceBP Macrogol Glycerol Cocoates 2 SolubilityBP Macrogol Glycerol Cocoates 3 Relative densityBP Macrogol Glycerol Cocoates 4 Identification ABP Macrogol Glycerol Cocoates 5 Identification BBP Macrogol Glycerol Cocoates 6 Identification CBP Macrogol Glycerol Cocoates 7 Appearance (Tests)BP Macrogol Glycerol Cocoates 8 AlkalinityBP Macrogol Glycerol Cocoates 9 Acid ValueBP Macrogol Glycerol Cocoates 10 Hydroxyl ValueBP Macrogol Glycerol Cocoates 11 Saponification ValueBP Macrogol Glycerol Cocoates 12 Iodine ValueBP Macrogol Glycerol Cocoates 14 WaterBP Macrogol Glycerol Cocoates 15 Total Ash

13 Composition of fatty acids

13 Linoleic acid

13 Oleic acid

13 Stearic acid

13 Palmitic acid

13 Myristic acid

13 Caprylic acid

13 Capric acid

13 Caproic Acid

13 Lauric acid

14 Ethylene oxide and dioxan

BP Macrogol Stearate 1 AppearanceBP Macrogol Stearate 2 SolubilityBP Macrogol Stearate 3 Identification ABP Macrogol Stearate 5 AlkalinityBP Macrogol Stearate 6 Melting point

BP Macrogol Cetostearyl Ether (Residual impurities)

BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)BP Macrogol Glycerol Cocoates (Residual impurities and/or Composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 60 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Macrogol Stearate 7 Acid Value

BP Macrogol Stearate 8 Hydroxyl ValueBP Macrogol Stearate 9 Iodine ValueBP Macrogol Stearate 10 Saponification ValueBP Macrogol Stearate 11 Reducing SubstancesBP Macrogol Stearate 14 Heavy MetalsBP Macrogol Stearate 15 WaterBP Macrogol Stearate 16 Total Ash

4 Identification B

12 Composition of fatty acids

12

12 Stearic acid

13 Ethylene oxide and dioxanBP Macrogols 1 Identification ABP Macrogols 2 Identification BBP Macrogols 3 Identification CBP Macrogols 4 Appearance of solutionBP Macrogols 5 Acidity or alkalinityBP Macrogols 6 ViscosityBP Macrogols 7 Freezing PointBP Macrogols 8 Hydroxyl ValueBP Macrogols 9 Reducing SubstancesBP Macrogols 10 FormaldehydeBP Macrogols 11 Ethylene glycol and diethylene glycolBP Macrogols 12 Ethylene oxide and dioxanBP Macrogols 13 Heavy MetalsBP Macrogols 14 WaterBP Macrogols 15 Sulfated AshBP Magnesium Aspartate 1 Characters (Appearance and solubility)BP Magnesium Aspartate 2 Identification ABP Magnesium Aspartate 3 Identification BBP Magnesium Aspartate 4 Identification CBP Magnesium Aspartate 5 Appearance of solutionBP Magnesium Aspartate 6 pHBP Magnesium Aspartate 7 Specific Optical RotationBP Magnesium Aspartate 8 Ninhydrin-positive substancesBP Magnesium Aspartate 9 ChloridesBP Magnesium Aspartate 10 SulfatesBP Magnesium Aspartate 11 AmmoniumBP Magnesium Aspartate 12 IronBP Magnesium Aspartate 13 Heavy MetalsBP Magnesium Aspartate 14 waterBP Magnesium Aspartate 15 AssayBP Magnesium Chloride Hexahydrate 1 AppearanceBP Magnesium Chloride Hexahydrate 2 SolubilityBP Magnesium Chloride Hexahydrate 3 Identification ABP Magnesium Chloride Hexahydrate 4 Identification BBP Magnesium Chloride Hexahydrate 5 Identification C

BP Macrogol Stearate (ID B and/or Composition of fatty acids)BP Macrogol Stearate (ID B and/or Composition of fatty acids)BP Macrogol Stearate (ID B and/or Composition of fatty acids)

Sum of contents of palmitic acid and stearic acid

BP Macrogol Stearate (ID B and/or Composition of fatty acids)BP Macrogol Stearate (ID B and/or Composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 61 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Magnesium Chloride Hexahydrate 6 Appearance of solution

BP Magnesium Chloride Hexahydrate 7 Acidity or alkalinityBP Magnesium Chloride Hexahydrate 8 BromidesBP Magnesium Chloride Hexahydrate 9 SulfatesBP Magnesium Chloride Hexahydrate 10 AluminiumBP Magnesium Chloride Hexahydrate 11 CalciumBP Magnesium Chloride Hexahydrate 12 IronBP Magnesium Chloride Hexahydrate 12 PotassiumBP Magnesium Chloride Hexahydrate 14 Heavy MetalsBP Magnesium Chloride Hexahydrate 15 WaterBP Magnesium Chloride Hexahydrate 16 AssayBP Magnesium Gluconate 1 AppearanceBP Magnesium Gluconate 2 SolubilityBP Magnesium Gluconate 3 Identification ABP Magnesium Gluconate 4 Identification BBP Magnesium Gluconate 5 Appearance of solutionBP Magnesium Gluconate 6 Sucrose and reducing sugarsBP Magnesium Gluconate 7 ChloridesBP Magnesium Gluconate 8 SulfatesBP Magnesium Gluconate 9 Heavy MetalsBP Magnesium Gluconate 10 WaterBP Magnesium Gluconate 11 Assay (anhydrous substance)BP Magnesium Glycerophosphate 1 AppearanceBP Magnesium Glycerophosphate 2 SolubilityBP Magnesium Glycerophosphate 3 Identification ABP Magnesium Glycerophosphate 4 Identification BBP Magnesium Glycerophosphate 5 Identification CBP Magnesium Glycerophosphate 6 Appearance of solutionBP Magnesium Glycerophosphate 7 AcidityBP Magnesium Glycerophosphate 8 Glycerol and ethanol soluble substancesBP Magnesium Glycerophosphate 9 ChloridesBP Magnesium Glycerophosphate 10 PhosphatesBP Magnesium Glycerophosphate 11 SulfatesBP Magnesium Glycerophosphate 12 IronBP Magnesium Glycerophosphate 13 Heavy MetalsBP Magnesium Glycerophosphate 14 Loss on DryingBP Magnesium Glycerophosphate 15 AssayBP Magnesium Hydroxide Mixture 1 CharacteristicsBP Magnesium Hydroxide Mixture 2 Heavy MetalsBP Magnesium Hydroxide Mixture 3 SulfatesBP Magnesium Hydroxide Mixture 4 AssayBP Magnesium Stearate 1 AppearanceBP Magnesium Stearate 2 SolubilityBP Magnesium Stearate 3 Identification ABP Magnesium Stearate 4 Identification BBP Magnesium Stearate 6 Identification DBP Magnesium Stearate 7 Solution SBP Magnesium Stearate 8 Acidity or alkalinityBP Magnesium Stearate 9 ChlorideBP Magnesium Stearate 10 SulfateBP Magnesium Stearate 11 Loss on dryingBP Magnesium Stearate 12 Magnesium

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 62 of 181

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Monograph Name ANALYTETest Number

5 Identification C

13 Stearic acid and palmitic acid

13 Stearic Acid Content

13 Sum of Stearic and Palmitic acidsBP Magnesium Sulfate Heptahydrate 1 AppearanceBP Magnesium Sulfate Heptahydrate 2 SolubilityBP Magnesium Sulfate Heptahydrate 3 Identification ABP Magnesium Sulfate Heptahydrate 4 Identification BBP Magnesium Sulfate Heptahydrate 5 Appearance of solutionBP Magnesium Sulfate Heptahydrate 6 Acidity or alkalinityBP Magnesium Sulfate Heptahydrate 7 ChloridesBP Magnesium Sulfate Heptahydrate 8 IronBP Magnesium Sulfate Heptahydrate 9 Heavy MetalsBP Magnesium Sulfate Heptahydrate 10 Loss on dryingBP Magnesium Sulfate Heptahydrate 11 AssayBP Maize Starch 1 Appearance BP Maize Starch 2 SolubilityBP Maize Starch 4 Identification BBP Maize Starch 5 Identification CBP Maize Starch 6 pHBP Maize Starch 8 Oxidising substancesBP Maize Starch 9 Sulfur DioxideBP Maize Starch 10 IronBP Maize Starch 11 Loss on DryingBP Maize Starch 12 Sulfated ashBP Malathion 1 AppearanceBP Malathion 2 SolubilityBP Malathion 3 IdentificationBP Malathion 4 Relative densityBP Malathion 5 Optical rotationBP Malathion 7 Water

6 Related Substances

6 Impurity B

6 Sum of impurities other than A and B

6 Impurity A

8 AssayBP Malic Acid 1 AppearanceBP Malic Acid 2 SolubilityBP Malic Acid 3 Identification ABP Malic Acid 4 Identification BBP Malic Acid 5 Appearance of solutionBP Malic Acid 6 Optical rotationBP Malic Acid 7 Water Insoluble substancesBP Malic Acid 9 Heavy Metals

BP Magnesium Stearate (ID C and/or Stearic acid & palmitic acid )BP Magnesium Stearate (ID C and/or Stearic acid & palmitic acid )BP Magnesium Stearate (ID C and/or Stearic acid & palmitic acid )BP Magnesium Stearate (ID C and/or Stearic acid & palmitic acid )

BP Malathion (Assay and/or Related substances)BP Malathion (Assay and/or Related substances)BP Malathion (Assay and/or Related substances)BP Malathion (Assay and/or Related substances)BP Malathion (Assay and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 63 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Malic Acid 10 Water

BP Malic Acid 11 Sulfated AshBP Malic Acid 12 AssayBP Malic Acid (Related substances) 8 Related SubstancesBP Malic Acid (Related substances) 8 Total of other impuritiesBP Malic Acid (Related substances) 8 Impurity BBP Malic Acid (Related substances) 8 Any other impurityBP Malic Acid (Related substances) 8 Impurity ABP Maltodextrin 1 AppearanceBP Maltodextrin 2 SolubilityBP Maltodextrin 3 Identification ABP Maltodextrin 4 Identification BBP Maltodextrin 5 Identification CBP Maltodextrin 6 Identification DBP Maltodextrin 7 pHBP Maltodextrin 8 Sulfur DioxideBP Maltodextrin 9 Heavy MetalsBP Maltodextrin 10 Loss on dryingBP Maltodextrin 11 Sulfated AshBP Maltodextrin 12 Dextrose equivalent (DE)BP Manganese Sulfate Monohydrate 1 AppearanceBP Manganese Sulfate Monohydrate 2 SolubilityBP Manganese Sulfate Monohydrate 3 Identification ABP Manganese Sulfate Monohydrate 4 Identification BBP Manganese Sulfate Monohydrate 5 Identification CBP Manganese Sulfate Monohydrate 6 Appearance of solutionBP Manganese Sulfate Monohydrate 7 ChloridesBP Manganese Sulfate Monohydrate 8 IronBP Manganese Sulfate Monohydrate 9 ZincBP Manganese Sulfate Monohydrate 10 Heavy MetalsBP Manganese Sulfate Monohydrate 11 Loss on ignitionBP Manganese Sulfate Monohydrate 12 AssayBP Mannitol 1 AppearanceBP Mannitol 2 SolubilityBP Mannitol 3 Identification ABP Mannitol 4 Identification BBP Mannitol 5 Identification CBP Mannitol 6 Identification DBP Mannitol 7 Appearance of solutionBP Mannitol 8 ConductivityBP Mannitol 9 Reducing SugarsBP Mannitol 11 Water

10 Related Substances

10 Disregard limit

10 unspecified impurities

10 Total

10 Impurity C

BP Mannitol (Assay and/or Related substances)BP Mannitol (Assay and/or Related substances)BP Mannitol (Assay and/or Related substances)BP Mannitol (Assay and/or Related substances)BP Mannitol (Assay and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 64 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

10 Impurities A, B

12 AssayBP Mebendazole 1 AppearanceBP Mebendazole 2 SolubilityBP Mebendazole 3 Identification by Infrared AbsorptionBP Mebendazole 4 Related SubstancesBP Mebendazole 4 TotalBP Mebendazole 4 Impurity GBP Mebendazole 4 Impurities A, B, C, D, E, FBP Mebendazole 4 unspecified impuritiesBP Mebendazole 5 Loss on DryingBP Mebendazole 6 Sulfated AshBP Mebendazole 7 AssayBP Medium-chain Triglycerides 1 CharactersBP Medium-chain Triglycerides 3 Identification ABP Medium-chain Triglycerides 4 Identification BBP Medium-chain Triglycerides 6 Identification DBP Medium-chain Triglycerides 7 AppearanceBP Medium-chain Triglycerides 8 Alkaline ImpuritiesBP Medium-chain Triglycerides 9 Relative densityBP Medium-chain Triglycerides 10 Refractive indexBP Medium-chain Triglycerides 11 ViscosityBP Medium-chain Triglycerides 12 Acid ValueBP Medium-chain Triglycerides 13 Hydroxyl ValueBP Medium-chain Triglycerides 14 Iodine ValueBP Medium-chain Triglycerides 15 Peroxide ValueBP Medium-chain Triglycerides 16 Saponification ValueBP Medium-chain Triglycerides 17 Unsaponifiable matterBP Medium-chain Triglycerides 19 Heavy MetalsBP Medium-chain Triglycerides 20 WaterBP Medium-chain Triglycerides 21 Total Ash

4 Identification C

18 Composition of fatty acids

18 Caproic Acid

18 Caprylic acid

18 Myristic acid

18 Capric acid

18 Lauric acidBP Melting Point Softening pointBP Melting Point Melting pointBP Melting Point Drop Melting Point (Method III)BP Metaraminol Injection 1 Identification ABP Metaraminol Injection 2 Identification BBP Metaraminol Injection 3 Identification C

BP Mannitol (Assay and/or Related substances)BP Mannitol (Assay and/or Related substances)

BP Medium-chain Triglycerides (ID C and/or Composition of fatty acids)BP Medium-chain Triglycerides (ID C and/or Composition of fatty acids)BP Medium-chain Triglycerides (ID C and/or Composition of fatty acids)BP Medium-chain Triglycerides (ID C and/or Composition of fatty acids)BP Medium-chain Triglycerides (ID C and/or Composition of fatty acids)BP Medium-chain Triglycerides (ID C and/or Composition of fatty acids)BP Medium-chain Triglycerides (ID C and/or Composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 65 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Metaraminol Injection 4 Acidity

BP Metaraminol Injection 5 Related SubstancesBP Metaraminol Injection 6 AssayBP Methadone Hydrochloride 1 Appearance BP Methadone Hydrochloride 2 SolubilityBP Methadone Hydrochloride 3 Identification ABP Methadone Hydrochloride 4 Identification BBP Methadone Hydrochloride 5 Identification CBP Methadone Hydrochloride 6 Identification DBP Methadone Hydrochloride 7 Appearance of solutionBP Methadone Hydrochloride 8 Acidity or alkalinityBP Methadone Hydrochloride 9 Optical rotationBP Methadone Hydrochloride 10 Related SubstancesBP Methadone Hydrochloride 10 Impurities A,B,C,D,E BP Methadone Hydrochloride 10 Unspecified ImpuritiesBP Methadone Hydrochloride 10 Total ImpuritiesBP Methadone Hydrochloride 11 Loss on DryingBP Methadone Hydrochloride 12 Sulfated AshBP Methadone Hydrochloride 13 AssayBP Methanol 1 CharactersBP Methanol 2 Boiling PointBP Methanol 3 Identification ABP Methanol 4 Identification BBP Methanol 5 Appearance (Tests)BP Methanol 6 Acidity or alkalinityBP Methanol 7 Relative densityBP Methanol 8 AbsorbanceBP Methanol 11 Reducing SubstancesBP Methanol 12 Residue on evaporationBP Methanol 13 Water

9 Impurity A

10 Related Substances

10 Any impurity

10 TotalBP Methionine 1 CharactersBP Methionine 2 Identification ABP Methionine 3 Identification BBP Methionine 4 Identification CBP Methionine 5 Identification DBP Methionine 6 Appearance of solutionBP Methionine 7 pHBP Methionine 8 Specific Optical RotationBP Methionine 9 Ninhydrin-positive substancesBP Methionine 10 ChloridesBP Methionine 11 SulfatesBP Methionine 12 AmmoniumBP Methionine 13 IronBP Methionine 14 Heavy MetalsBP Methionine 15 Loss on Drying

BP Methanol (Impurity A and/or Related substances)BP Methanol (Impurity A and/or Related substances)BP Methanol (Impurity A and/or Related substances)BP Methanol (Impurity A and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 66 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Methionine 16 Sulfated Ash

BP Methionine 17 Assay (dried substance)BP Methyl Hydroxybenzoate 1 AppearanceBP Methyl Hydroxybenzoate 2 SolubilityBP Methyl Hydroxybenzoate 3 Identification ABP Methyl Hydroxybenzoate 4 Identification BBP Methyl Hydroxybenzoate 5 Identification CBP Methyl Hydroxybenzoate 6 Appearance of solutionBP Methyl Hydroxybenzoate 7 AcidityBP Methyl Hydroxybenzoate 9 Sulfated Ash

8 Related Substances

8 Impurity A

8 unspecified impurities

8 Total

10 AssayBP Methyl Salicylate 1 AppearanceBP Methyl Salicylate 2 SolubilityBP Methyl Salicylate 3 Identification ABP Methyl Salicylate 4 Identification BBP Methyl Salicylate 5 Appearance of solutionBP Methyl Salicylate 6 AcidityBP Methyl Salicylate 7 Relative densityBP Methyl Salicylate 8 Refractive indexBP Methyl Salicylate 9 AssayBP Miconazole Nitrate Appearance BP Miconazole Nitrate SolubilityBP Miconazole Nitrate Appearance of solutionBP Miconazole Nitrate Loss on DryingBP Miconazole Nitrate Identification DBP Miconazole Nitrate Identification ABP Miconazole Nitrate Identification BBP Miconazole Nitrate Sulfated AshBP Miconazole Nitrate AssayBP Miconazole Nitrate Optical RotationBP Miconazole Nitrate Identification CBP Miconazole Nitrate Related SubstancesBP Miconazole Nitrate Impurities A,B,C,D,E,F,GBP Miconazole Nitrate Unspecified ImpuritiesBP Miconazole Nitrate TotalBP Microcrystalline Cellulose 1 CharactersBP Microcrystalline Cellulose 2 Identification ABP Microcrystalline Cellulose 3 Identification BBP Microcrystalline Cellulose 4 Solubility (Tests)BP Microcrystalline Cellulose 5 pHBP Microcrystalline Cellulose 6 ConductivityBP Microcrystalline Cellulose 7 Ether-soluble substancesBP Microcrystalline Cellulose 8 Water-soluble substancesBP Microcrystalline Cellulose 9 Heavy Metals

BP Methyl Hydroxybenzoate (Assay and/or Related substances)BP Methyl Hydroxybenzoate (Assay and/or Related substances)BP Methyl Hydroxybenzoate (Assay and/or Related substances)BP Methyl Hydroxybenzoate (Assay and/or Related substances)BP Methyl Hydroxybenzoate (Assay and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 67 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Microcrystalline Cellulose 10 Loss on drying

BP Microcrystalline Cellulose 11 Sulfated Ash1 Appearance

2 Solubility

3 Identification A

4 Identification B

5 Identification C

6 Identification D

7 Solubility (Tests)

8 pH

9 Loss on drying

10 Sulfated Ash

11 Assay

12 Apparent viscosityBP Midazolam 1 AppearanceBP Midazolam 2 SolubilityBP Midazolam 3 Identification ABP Midazolam 4 Identification BBP Midazolam 5 Identification CBP Midazolam 6 Identification DBP Midazolam 7 Identification EBP Midazolam 8 Appearance of solutionBP Midazolam 9 Related SubstancesBP Midazolam 9 Impurity BBP Midazolam 9 Impurities A, E,G,HBP Midazolam 9 Unspecified ImpuritiesBP Midazolam 9 TotalBP Midazolam 10 Impurity CBP Midazolam 11 Loss on DryingBP Midazolam 12 Sulfated AshBP Midazolam 13 Assay (dried substance)BP myo-Inositol 1 AppearanceBP myo-Inositol 2 SolubilityBP myo-Inositol 3 Identification ABP myo-Inositol 5 Appearance of solutionBP myo-Inositol 6 ConductivityBP myo-Inositol 8 BariumBP myo-Inositol 9 Water

4 Identification B

BP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose SodiumBP Microcrystalline Cellulose and Carmellose Sodium

BP myo-Inositol (ID B and /or Assay and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 68 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

7 Related Substances

7 unspecified impurities

7 Impurities A, B

7 Total

10 AssayBP Naproxen Oral Suspension 1 Identification ABP Naproxen Oral Suspension 2 Identification BBP Naproxen Oral Suspension 3 AcidityBP Naproxen Oral Suspension 4 Related SubstancesBP Naproxen Oral Suspension 5 AssayBP Nicergoline 1 AppearanceBP Nicergoline 2 SolubilityBP Nicergoline 3 Identification ABP Nicergoline 4 Identification BBP Nicergoline 5 Identification CBP Nicergoline 6 Appearance of solutionBP Nicergoline 7 Related SubstancesBP Nicergoline 7 Impurity HBP Nicergoline 7 Impurities C,F, IBP Nicergoline 7 Impurity BBP Nicergoline 7 Impurity DBP Nicergoline 7 Impurity ABP Nicergoline 7 unspecified impuritiesBP Nicergoline 7 TotalBP Nicergoline 8 WaterBP Nicergoline 9 Sulfated AshBP Nicergoline 10 Assay (anhydrous substance)BP Nicotinamide 1 CharactersBP Nicotinamide 2 Identification ABP Nicotinamide 3 Identification BBP Nicotinamide 4 Identification CBP Nicotinamide 5 Identification DBP Nicotinamide 6 Appearance of solutionBP Nicotinamide 7 pHBP Nicotinamide 8 Related SubstancesBP Nicotinamide 9 Heavy MetalsBP Nicotinamide 10 Loss on dryingBP Nicotinamide 11 Sulfated AshBP Nicotinamide 12 AssayBP Nicotinic Acid 1 AppearanceBP Nicotinic Acid 2 SolubilityBP Nicotinic Acid 3 Identification ABP Nicotinic Acid 4 Identification BBP Nicotinic Acid 5 Identification CBP Nicotinic Acid 7 ChloridesBP Nicotinic Acid 8 Heavy MetalsBP Nicotinic Acid 9 Loss on dryingBP Nicotinic Acid 10 Sulfated Ash

BP myo-Inositol (ID B and /or Assay and/or Related substances)BP myo-Inositol (ID B and /or Assay and/or Related substances)BP myo-Inositol (ID B and /or Assay and/or Related substances)BP myo-Inositol (ID B and /or Assay and/or Related substances)BP myo-Inositol (ID B and /or Assay and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 69 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Nicotinic Acid 11 Assay (dried substance)

BP Nicotinic Acid (Related substances) 6 Related SubstancesBP Nicotinic Acid (Related substances) 6 unspecified impuritiesBP Nicotinic Acid (Related substances) 6 TotalBP Nitrazepam 1 AppearanceBP Nitrazepam 2 SolubilityBP Nitrazepam 3 IdentificationBP Nitrazepam 4 Related SubstancesBP Nitrazepam 4 unspecified impuritiesBP Nitrazepam 4 TotalBP Nitrazepam 5 Loss on DryingBP Nitrazepam 6 Sulfated AshBP Nitrazepam 7 Assay (dried substance)BP Nitric Acid 1 AppearanceBP Nitric Acid 2 SolubilityBP Nitric Acid 3 Appearance of solutionBP Nitric Acid 4 ChloridesBP Nitric Acid 5 SulfatesBP Nitric Acid 6 IronBP Nitric Acid 7 Heavy MetalsBP Nitric Acid 8 Sulfated AshBP Nitric Acid 9 AssayBP Nutmeg Oil 1 AppearanceBP Nutmeg Oil 2 Identification ABP Nutmeg Oil 4 Relative densityBP Nutmeg Oil 5 Refractive indexBP Nutmeg Oil 6 Optical rotation

3 Identification B

7 Chromatographic Profile

7 Car-3-ene

7 beta-Pinene

7 Myristicine

7 Terpinen-4-ol

7 Limonene

7 alpha-Pinene

7 Safrole

7 gamma-Terpinene

7 SabineneBP Octyldodecanol 1 AppearanceBP Octyldodecanol 2 SolubilityBP Octyldodecanol 3 Relative densityBP Octyldodecanol 4 Refractive index

BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)BP Nutmeg Oil (ID B and/or Chromatography profile)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 70 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Octyldodecanol 5 Identification A

BP Octyldodecanol 6 Identification BBP Octyldodecanol 7 Acidity or alkalinityBP Octyldodecanol 8 Optical rotationBP Octyldodecanol 9 Hydroxyl ValueBP Octyldodecanol 10 Iodine ValueBP Octyldodecanol 11 Peroxide ValueBP Octyldodecanol 12 Saponification ValueBP Octyldodecanol 13 Heavy MetalsBP Octyldodecanol 14 WaterBP Octyldodecanol 15 Sulfated AshBP Octyldodecanol 16 AssayBP Oleic Acid 1 AppearanceBP Oleic Acid 2 SolubilityBP Oleic Acid 3 Relative densityBP Oleic Acid 4 Identification ABP Oleic Acid 5 Identification BBP Oleic Acid 7 Appearance (Tests)BP Oleic Acid 8 Acid ValueBP Oleic Acid 9 Iodine ValueBP Oleic Acid 10 Peroxide ValueBP Oleic Acid 12 Total Ash

6 Identification C

11 Composition of fatty acids

11 Palmitic acid

11 Stearic acid

11 Linoleic acid

11 Oleic acid

11 Palmitoleic acid

11 Linolenic acid

11

11 Myristic acidBP Oleoyl Macrogolglycerides 1 AppearanceBP Oleoyl Macrogolglycerides 2 SolubilityBP Oleoyl Macrogolglycerides 3 ViscosityBP Oleoyl Macrogolglycerides 4 Relative DensityBP Oleoyl Macrogolglycerides 5 Refractive IndexBP Oleoyl Macrogolglycerides 6 Identification ABP Oleoyl Macrogolglycerides 7 Identification BBP Oleoyl Macrogolglycerides 8 Identification CBP Oleoyl Macrogolglycerides 9 Identification DBP Oleoyl Macrogolglycerides 10 Acid ValueBP Oleoyl Macrogolglycerides 11 Hydroxyl Value

BP Oleic Acid (ID C and/or Composition of fatty acids)BP Oleic Acid (ID C and/or Composition of fatty acids)BP Oleic Acid (ID C and/or Composition of fatty acids)BP Oleic Acid (ID C and/or Composition of fatty acids)BP Oleic Acid (ID C and/or Composition of fatty acids)BP Oleic Acid (ID C and/or Composition of fatty acids)BP Oleic Acid (ID C and/or Composition of fatty acids)BP Oleic Acid (ID C and/or Composition of fatty acids)BP Oleic Acid (ID C and/or Composition of fatty acids)

fatty acids of chain length greater than C18

BP Oleic Acid (ID C and/or Composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 71 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Oleoyl Macrogolglycerides 12 Iodine Value

BP Oleoyl Macrogolglycerides 13 Peroxide ValueBP Oleoyl Macrogolglycerides 14 Saponificaiton ValueBP Oleoyl Macrogolglycerides 15 Alkaline ImpuritiesBP Oleoyl Macrogolglycerides 16 Free GlycolBP Oleoyl Macrogolglycerides 17 Composition of fatty acidsBP Oleoyl Macrogolglycerides 17 Palmitic acidBP Oleoyl Macrogolglycerides 17 Stearic acidBP Oleoyl Macrogolglycerides 17 Oleic acidBP Oleoyl Macrogolglycerides 17 Linoleic acidBP Oleoyl Macrogolglycerides 17 Linolenic acidBP Oleoyl Macrogolglycerides 17 Arachidic acidBP Oleoyl Macrogolglycerides 17 eicosenoic acidBP Oleoyl Macrogolglycerides 18 Ethylene oxide and dioxanBP Oleoyl Macrogolglycerides 19 Heavy MetalsBP Oleoyl Macrogolglycerides 20 WaterBP Oleoyl Macrogolglycerides 21 Total AshBP Oxetacaine 1 CharactersBP Oxetacaine 2 IdentificationBP Oxetacaine 3 Melting pointBP Oxetacaine 4 Related SubstancesBP Oxetacaine 5 Loss on dryingBP Oxetacaine 6 Sulfated AshBP Oxetacaine 7 AssayBP Paracetamol 1 AppearanceBP Paracetamol 2 SolubilityBP Paracetamol 3 Identification ABP Paracetamol 4 Identification BBP Paracetamol 5 Identification CBP Paracetamol 6 Identification DBP Paracetamol 7 Identification EBP Paracetamol 9 Heavy MetalsBP Paracetamol 10 Loss on DryingBP Paracetamol 11 Sulfated AshBP Paracetamol 12 AssayBP Paracetamol (Related substances) 8 Related SubstancesBP Paracetamol (Related substances) 8 Any other impurityBP Paracetamol (Related substances) 8 Impurity FBP Paracetamol (Related substances) 8 Impurity KBP Paracetamol (Related substances) 8 Total of other impuritiesBP Paracetamol (Related substances) 8 Impurity JBP Pentobarbital 1 CharactersBP Pentobarbital 2 Identification ABP Pentobarbital 3 Identification BBP Pentobarbital 4 Identification CBP Pentobarbital 5 Appearance of SolutionBP Pentobarbital 6 AcidityBP Pentobarbital 7 Related SubstancesBP Pentobarbital 8 IsomerBP Pentobarbital 9 Loss on DryingBP Pentobarbital 10 Sulfated AshBP Pentobarbital 11 Assay

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 72 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Pentobarbital Sodium 1 Characters

BP Pentobarbital Sodium 2 Identification ABP Pentobarbital Sodium 3 Identification BBP Pentobarbital Sodium 4 Identification CBP Pentobarbital Sodium 5 Identification DBP Pentobarbital Sodium 6 pHBP Pentobarbital Sodium 7 Related SubstancesBP Pentobarbital Sodium 8 Free PentobarbitalBP Pentobarbital Sodium 9 IsomerBP Pentobarbital Sodium 10 Heavy MetalsBP Pentobarbital Sodium 11 Loss on DryingBP Pentobarbital Sodium 12 AssayBP Peppermint Oil 1 AppearanceBP Peppermint Oil 2 SolubilityBP Peppermint Oil 3 Identification ABP Peppermint Oil 5 Relative densityBP Peppermint Oil 6 Refractive indexBP Peppermint Oil 7 Optical rotationBP Peppermint Oil 8 Acid ValueBP Peppermint Oil 9 Fatty oils and resinified essential oilsBP Peppermint Oil 10 Mint oil

4 Identification B

11 Chromatographic Profile

11 Isomenthone

11 Limonene

11 Menthone

11 Cineole

11 Menthofuran

11 Isopulegol

11 Menthyl acetate

11 Menthol

11 Pulegone

11 CarvoneBP Peroxide value Peroxide ValueBP Phenazone 1 AppearanceBP Phenazone 2 SolubilityBP Phenazone 3 Identification ABP Phenazone 4 Identification BBP Phenazone 5 Identification CBP Phenazone 6 Identification DBP Phenazone 7 Appearance of solution

BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )BP Peppermint Oil (Chromatographic profile )

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 73 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Phenazone 8 Acidity or alkalinity

BP Phenazone 10 ChloridesBP Phenazone 11 SulfatesBP Phenazone 12 Heavy MetalsBP Phenazone 13 Loss on DryingBP Phenazone 14 Sulfated AshBP Phenazone 15 AssayBP Phenazone (Related substances) 9 Related SubstancesBP Phenazone (Related substances) 9 Impurity ABP Phenazone (Related substances) 9 unspecified impuritiesBP Phenazone (Related substances) 9 TotalBP Phenobarbital 1 Appearance BP Phenobarbital 2 solubilityBP Phenobarbital 3 Identification ABP Phenobarbital 4 Identification BBP Phenobarbital 5 Identification CBP Phenobarbital 6 Identification DBP Phenobarbital 7 Appearance of solutionBP Phenobarbital 8 AcidityBP Phenobarbital 9 Related SubstancesBP Phenobarbital 9 Impurity ABP Phenobarbital 9 Impurity BBP Phenobarbital 9 Unspecified ImpuritiesBP Phenobarbital 9 TotalBP Phenobarbital 10 Loss on DryingBP Phenobarbital 11 Sulfated AshBP Phenobarbital 12 AssayBP Phenol 1 AppearanceBP Phenol 2 SolubilityBP Phenol 3 Identification ABP Phenol 4 Identification BBP Phenol 5 Identification CBP Phenol 6 Appearance of solutionBP Phenol 7 AcidityBP Phenol 8 Freezing PointBP Phenol 9 Residue on evaporationBP Phenol 10 AssayBP Phenolphthalein 1 CharactersBP Phenolphthalein 2 Identification ABP Phenolphthalein 3 Identification BBP Phenolphthalein 4 Appearance of solutionBP Phenolphthalein 5 Acidity or alkalinityBP Phenolphthalein 6 Related SubstancesBP Phenolphthalein 7 ChloridesBP Phenolphthalein 8 SulfatesBP Phenolphthalein 9 Heavy MetalsBP Phenolphthalein 10 Loss on DryingBP Phenolphthalein 11 Sulfated AshBP Phenolphthalein 12 AssayBP Phenolsulfonphthalein 1 CharactersBP Phenolsulfonphthalein 1 CharactersBP Phenolsulfonphthalein 2 Identification A

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 74 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Phenolsulfonphthalein 2 Identification A

BP Phenolsulfonphthalein 3 Identification BBP Phenolsulfonphthalein 3 Identification BBP Phenolsulfonphthalein 4 Identification CBP Phenolsulfonphthalein 4 Identification CBP Phenolsulfonphthalein 5 Related Substances (TLC)BP Phenolsulfonphthalein 5 Related SubstancesBP Phenolsulfonphthalein 6 Insoluble MatterBP Phenolsulfonphthalein 6 Insoluble MatterBP Phenolsulfonphthalein 7 Loss on DryingBP Phenolsulfonphthalein 7 Loss on DryingBP Phenolsulfonphthalein 8 Sulfated AshBP Phenolsulfonphthalein 8 Sulfated AshBP Phenolsulfonphthalein 9 AssayBP Phenolsulfonphthalein 9 AssayBP Phenoxyethanol 1 AppearanceBP Phenoxyethanol 2 SolubilityBP Phenoxyethanol 3 Identification ABP Phenoxyethanol 4 Identification BBP Phenoxyethanol 5 Identification CBP Phenoxyethanol 6 Identification DBP Phenoxyethanol 7 Relative densityBP Phenoxyethanol 9 PhenolBP Phenoxyethanol 10 AssayBP Phenoxyethanol 8 Related SubstancesBP Phenoxyethanol 8 Total limitBP Phenylalanine 1 AppearanceBP Phenylalanine 2 SolubilityBP Phenylalanine 3 Identification ABP Phenylalanine 4 Identification BBP Phenylalanine 5 Identification CBP Phenylalanine 6 Identification DBP Phenylalanine 7 Appearance of SolutionBP Phenylalanine 8 Specific Optical RotationBP Phenylalanine 9 Ninhydrin Positive SubstancesBP Phenylalanine 10 ChloridesBP Phenylalanine 11 SulfatesBP Phenylalanine 12 AmmoniaBP Phenylalanine 13 IronBP Phenylalanine 14 Heavy MetalsBP Phenylalanine 15 Loss on DryingBP Phenylalanine 16 Sulfated AshBP Phenylalanine 17 AssayBP Phenylephrine Hydrochloride 1 AppearanceBP Phenylephrine Hydrochloride 2 SolubilityBP Phenylephrine Hydrochloride 3 Melting pointBP Phenylephrine Hydrochloride 4 Identification ABP Phenylephrine Hydrochloride 5 Identification BBP Phenylephrine Hydrochloride 6 Identification CBP Phenylephrine Hydrochloride 7 Identification DBP Phenylephrine Hydrochloride 8 Identification EBP Phenylephrine Hydrochloride 9 Appearance of solution

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 75 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Phenylephrine Hydrochloride 10 Acidity or alkalinity

BP Phenylephrine Hydrochloride 11 Specific Optical RotationBP Phenylephrine Hydrochloride 12 Related SubstancesBP Phenylephrine Hydrochloride 12 unspecified impuritiesBP Phenylephrine Hydrochloride 12 Impurities C, EBP Phenylephrine Hydrochloride 12 Total impuritiesBP Phenylephrine Hydrochloride 13 SulfatesBP Phenylephrine Hydrochloride 14 Loss on DryingBP Phenylephrine Hydrochloride 15 Sulfated AshBP Phenylephrine Hydrochloride 16 Assay (dried basis)BP Phosphoric Acid 1 AppearanceBP Phosphoric Acid 2 SolubilityBP Phosphoric Acid 3 Relative densityBP Phosphoric Acid 4 Identification ABP Phosphoric Acid 5 Identification BBP Phosphoric Acid 6 Appearance of solutionBP Phosphoric Acid 7 Substances precipitated with ammoniaBP Phosphoric Acid 8BP Phosphoric Acid 9 ChloridesBP Phosphoric Acid 10 SulfatesBP Phosphoric Acid 11 IronBP Phosphoric Acid 12 Heavy MetalsBP Phosphoric Acid 13 AssayBP Pilocarpine Nitrate Eye Drops 1 IdentificationBP Pilocarpine Nitrate Eye Drops 2 Acidity

3 Pilocarpic acid

4 AssayBP Pimobendan 1 AppearanceBP Pimobendan 2 SolubilityBP Pimobendan 3 Melting PointBP Pimobendan 4 Identification (FTIR)BP Pimobendan 5 Related SubstancesBP Pimobendan 5 Impurities A,BBP Pimobendan 5 Any other ImpurityBP Pimobendan 5 TotalBP Pimobendan 6 Heavy Metals (Test F)BP Pimobendan 7 WaterBP Pimobendan 8 Sulfated AshBP Pimobendan 9 AssayBP Pinus Pinaster Type Turpentine Oil 1 AppearanceBP Pinus Pinaster Type Turpentine Oil 2 Identification ABP Pinus Pinaster Type Turpentine Oil 4 Relative densityBP Pinus Pinaster Type Turpentine Oil 5 Refractive indexBP Pinus Pinaster Type Turpentine Oil 6 Optical rotationBP Pinus Pinaster Type Turpentine Oil 7 Acid ValueBP Pinus Pinaster Type Turpentine Oil 8 Peroxide ValueBP Pinus Pinaster Type Turpentine Oil 9 Fatty oils and resinified essential oilsBP Pinus Pinaster Type Turpentine Oil 11 Residue on evaporation

3 Identification B

Hypophosphorous acid and Phophorous acid

BP Pilocarpine Nitrate Eye Drops (Pilocarpic acid and/or Assay)BP Pilocarpine Nitrate Eye Drops (Pilocarpic acid and/or Assay)

BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 76 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

10 Chromatographic Profile

10 Camphene

10 Car-3-ene

10 Limonene

10 beta-Caryophyllene

10 alpha-Pinene

10 beta-Pinene

10 beta-Myrcene

10 Longifolene

10 Caryophyllene oxideBP Piperonyl Butoxide 1 CharacteristicsBP Piperonyl Butoxide 2 Identification ABP Piperonyl Butoxide 3 Identification BBP Piperonyl Butoxide 4 Identification CBP Piperonyl Butoxide 5 Refractive IndexBP Piperonyl Butoxide 6 Weight per mLBP Piperonyl Butoxide 7 Sulfated AshBP Plastic Containers and Closures 1 Appearance of solutionBP Plastic Containers and Closures 2 Acidity or alkalinityBP Plastic Containers and Closures 3 AbsorbanceBP Plastic Containers and Closures 4 Reducing SubstancesBP Plastic Containers and Closures 5 TransparencyBP Poloxamers 1 AppearanceBP Poloxamers 2 SolubilityBP Poloxamers 3 Melting pointBP Poloxamers 4 Appearance of solutionBP Poloxamers 5 pHBP Poloxamers 6 Average relative molecular massBP Poloxamers 7 WaterBP Poloxamers 8 Total Ash

6 Dioxane

6 Propylene Oxide

6 Ethylene oxideBP Polyethylene 1 AppearanceBP Polyethylene 2 SolubilityBP Polyethylene 3 Relative densityBP Polyethylene 4 Identification ABP Polyethylene 5 Identification BBP Polyethylene 6 Solution S1BP Polyethylene 7 Solution S2

BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)BP Pinus Pinaster Type Turpentine Oil (ID B and/or Chromatographic profile)

BP Poloxamers (Ethylene oxide, propylene oxide and dioxin)BP Poloxamers (Ethylene oxide, propylene oxide and dioxin)BP Poloxamers (Ethylene oxide, propylene oxide and dioxin)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 77 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Polyethylene 8 Solution S3

BP Polyethylene 9 Appearance of solutionBP Polyethylene 10 Acidity or alkalinityBP Polyethylene 11 AbsorbanceBP Polyethylene 12 Reducing SubstancesBP Polyethylene 13 Substances soluble in hexaneBP Polyethylene 14 AdditivesBP Polyethylene 15 Extractable Heavy MetalsBP Polyethylene 16 Sulfated AshBP Polyoxyl Castor Oil 1 AppearanceBP Polyoxyl Castor Oil 2 SolubilityBP Polyoxyl Castor Oil 3 Relative densityBP Polyoxyl Castor Oil 4 ViscosityBP Polyoxyl Castor Oil 4 Identification ABP Polyoxyl Castor Oil 5 Identification BBP Polyoxyl Castor Oil 6 Identification CBP Polyoxyl Castor Oil 7 Appearance of solutionBP Polyoxyl Castor Oil 8 AlkalinityBP Polyoxyl Castor Oil 9 Acid ValueBP Polyoxyl Castor Oil 10 Hydroxyl ValueBP Polyoxyl Castor Oil 11 Iodine ValueBP Polyoxyl Castor Oil 12 Saponification ValueBP Polyoxyl Castor Oil 14 Heavy MetalsBP Polyoxyl Castor Oil 15 WaterBP Polyoxyl Castor Oil 16 Total Ash

13 Residual ethylene oxide and dioxan

1 Appearance

2 Solubility

3 Identification A

4 Identification B

5 Identification C

6 Solution S1

7 Solution S2

8 Solution S3

9 Appearance of solution

10 Acidity or alkalinity

11 Absorbance

12 Reducing Substances

13 Substances soluble in hexane

BP Polyoxyl Castor Oil (Ethylene oxide & dioxan)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 78 of 181

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Monograph Name ANALYTETest Number

14 Extractable aluminium

15 Extractable chromium

16 Extractable titanium

17 Extractable vanadium

18 Extractable Zinc

19 Sulfated Ash

19 Extractable heavy metalsBP Polysorbate 20 1 AppearanceBP Polysorbate 20 2 SolubilityBP Polysorbate 20 3 Relative densityBP Polysorbate 20 4 ViscosityBP Polysorbate 20 5 Identification ABP Polysorbate 20 6 Identification BBP Polysorbate 20 7 Identification CBP Polysorbate 20 9 Identification EBP Polysorbate 20 10 Acid ValueBP Polysorbate 20 11 Hydroxyl ValueBP Polysorbate 20 12 Peroxide ValueBP Polysorbate 20 13 Saponification ValueBP Polysorbate 20 16 Heavy MetalsBP Polysorbate 20 17 WaterBP Polysorbate 20 18 Total Ash

8 Identification D

14 Composition of fatty acids

14 Caprylic acid

14 Lauric acid

14 Palmitic acid

14 Oleic acid

14 Myristic acid

14 Capric acid

14 Caproic Acid

14 Linoleic Acid

14 Stearic acid

15 Ethylene oxide and dioxanBP Polysorbate 60 1 Appearance

BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)BP Polypropylene for Containers (Appendix XX D)

BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)BP Polysorbate 20 (ID D and/or composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 79 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Polysorbate 60 2 Solubility

BP Polysorbate 60 3 Relative densityBP Polysorbate 60 4 ViscosityBP Polysorbate 60 5 Identification ABP Polysorbate 60 6 Identification BBP Polysorbate 60 7 Identification CBP Polysorbate 60 8 Identification DBP Polysorbate 60 9 Identification EBP Polysorbate 60 10 Acid ValueBP Polysorbate 60 11 Hydroxyl ValueBP Polysorbate 60 12 Peroxide ValueBP Polysorbate 60 13 Saponification ValueBP Polysorbate 60 14 Composition of fatty acidsBP Polysorbate 60 14 Stearic acidBP Polysorbate 60 14 Sum of Stearic and Palmitic acidsBP Polysorbate 60 15 Ethylene oxide and dioxanBP Polysorbate 60 16 Heavy MetalsBP Polysorbate 60 17 WaterBP Polysorbate 60 18 Total AshBP Polysorbate 80 1 AppearanceBP Polysorbate 80 2 SolubilityBP Polysorbate 80 3 Relative densityBP Polysorbate 80 4 Viscosity (capillary)BP Polysorbate 80 5 Identification ABP Polysorbate 80 6 Identification BBP Polysorbate 80 7 Identification CBP Polysorbate 80 9 Identification EBP Polysorbate 80 10 Acid ValueBP Polysorbate 80 11 Hydroxyl ValueBP Polysorbate 80 12 Peroxide ValueBP Polysorbate 80 13 Saponification ValueBP Polysorbate 80 16 Heavy MetalsBP Polysorbate 80 17 WaterBP Polysorbate 80 18 Total Ash

8 Identification D

14 Composition of fatty acids

14 Linolenic acid

14 Linoleic acid

14 Oleic acid

14 Palmitoleic acid

14 Palmitic acid

14 Myristic acid

14 Stearic acid

BP Polysorbate 80 (ID D and/or composition of fatty acids)BP Polysorbate 80 (ID D and/or composition of fatty acids)BP Polysorbate 80 (ID D and/or composition of fatty acids)BP Polysorbate 80 (ID D and/or composition of fatty acids)BP Polysorbate 80 (ID D and/or composition of fatty acids)BP Polysorbate 80 (ID D and/or composition of fatty acids)BP Polysorbate 80 (ID D and/or composition of fatty acids)BP Polysorbate 80 (ID D and/or composition of fatty acids)BP Polysorbate 80 (ID D and/or composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 80 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

15 Ethylene oxide and dioxanBP Potassium Carbonate 1 AppearanceBP Potassium Carbonate 2 SolubilityBP Potassium Carbonate 3 Identification ABP Potassium Carbonate 4 Identification BBP Potassium Carbonate 5 Identification CBP Potassium Carbonate 6 Appearance of solutionBP Potassium Carbonate 7 ChloridesBP Potassium Carbonate 8 SulfatesBP Potassium Carbonate 9 CalciumBP Potassium Carbonate 10 IronBP Potassium Carbonate 11 Heavy MetalsBP Potassium Carbonate 12 Loss on DryingBP Potassium Carbonate 13 Assay (dried substance)BP Potassium Chloride 1 AppearanceBP Potassium Chloride 2 SolubilityBP Potassium Chloride 3 Identification ABP Potassium Chloride 4 Identification BBP Potassium Chloride 5 Appearance of solutionBP Potassium Chloride 6 Acidity or alkalinityBP Potassium Chloride 7 BromidesBP Potassium Chloride 8 IodidesBP Potassium Chloride 9 SulfatesBP Potassium Chloride 10 AluminiumBP Potassium Chloride 11 BariumBP Potassium Chloride 12 IronBP Potassium Chloride 13 Magnesium and alkaline-earth metalsBP Potassium Chloride 14 SodiumBP Potassium Chloride 15 Heavy MetalsBP Potassium Chloride 16 Loss on dryingBP Potassium Chloride 17 AssayBP Potassium Chloride AluminiumBP Potassium Citrate 1 AppearanceBP Potassium Citrate 2 SolubilityBP Potassium Citrate 3 Identification ABP Potassium Citrate 4 Identification BBP Potassium Citrate 5 Appearance of solutionBP Potassium Citrate 6 Acidity or alkalinityBP Potassium Citrate 7 Readily carbonisable substancesBP Potassium Citrate 8 ChloridesBP Potassium Citrate 9 OxalatesBP Potassium Citrate 10 SulfatesBP Potassium Citrate 11 Heavy MetalsBP Potassium Citrate 12 SodiumBP Potassium Citrate 13 WaterBP Potassium Citrate 14 Assay

1 Characters

2 Identification A

3 Identification B

BP Polysorbate 80 (ID D and/or composition of fatty acids)

BP Potassium Dichromate for Homeopathic PreparationsBP Potassium Dichromate for Homeopathic PreparationsBP Potassium Dichromate for Homeopathic Preparations

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 81 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

4 Appearance of Solution

5 Calcium

6 Chlorides

7 Sulfates

8 AssayBP Potassium Dihydrogen Phosphate 1 AppearanceBP Potassium Dihydrogen Phosphate 2 SolubilityBP Potassium Dihydrogen Phosphate 3 Identification ABP Potassium Dihydrogen Phosphate 4 Identification BBP Potassium Dihydrogen Phosphate 5 Identification CBP Potassium Dihydrogen Phosphate 6 Appearance of solutionBP Potassium Dihydrogen Phosphate 7 pHBP Potassium Dihydrogen Phosphate 8 Reducing SubstancesBP Potassium Dihydrogen Phosphate 9 ChloridesBP Potassium Dihydrogen Phosphate 10 SulfatesBP Potassium Dihydrogen Phosphate 11 IronBP Potassium Dihydrogen Phosphate 12 SodiumBP Potassium Dihydrogen Phosphate 13 Heavy MetalsBP Potassium Dihydrogen Phosphate 14 Loss on DryingBP Potassium Dihydrogen Phosphate 15 AssayBP Potassium Hydroxide 1 AppearanceBP Potassium Hydroxide 2 SolubilityBP Potassium Hydroxide 3 Identification ABP Potassium Hydroxide 4 Identification BBP Potassium Hydroxide 5 Appearance of solutionBP Potassium Hydroxide 6 CarbonatesBP Potassium Hydroxide 7 ChloridesBP Potassium Hydroxide 8 PhosphatesBP Potassium Hydroxide 9 SulfatesBP Potassium Hydroxide 10 AluminiumBP Potassium Hydroxide 11 IronBP Potassium Hydroxide 13 Heavy MetalsBP Potassium Hydroxide 14 AssayBP Potassium Iodide 1 AppearanceBP Potassium Iodide 2 SolubilityBP Potassium Iodide 3 Identification ABP Potassium Iodide 4 Identification BBP Potassium Iodide 5 Appearance of solutionBP Potassium Iodide 6 AlkalinityBP Potassium Iodide 7 IodatesBP Potassium Iodide 8 SulfatesBP Potassium Iodide 9 ThiosulfatesBP Potassium Iodide 10 IronBP Potassium Iodide 11 Heavy MetalsBP Potassium Iodide 12 Loss on DryingBP Potassium Iodide 13 AssayBP Potassium Nitrate 1 AppearanceBP Potassium Nitrate 2 Solubility

BP Potassium Dichromate for Homeopathic PreparationsBP Potassium Dichromate for Homeopathic PreparationsBP Potassium Dichromate for Homeopathic PreparationsBP Potassium Dichromate for Homeopathic PreparationsBP Potassium Dichromate for Homeopathic Preparations

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 82 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Potassium Nitrate 3 Identification A

BP Potassium Nitrate 4 Identification BBP Potassium Nitrate 5 Appearance of solutionBP Potassium Nitrate 6 Acidity or alkalinityBP Potassium Nitrate 7 Reducible substancesBP Potassium Nitrate 8 ChloridesBP Potassium Nitrate 9 sulfatesBP Potassium Nitrate 10 AmmoniumBP Potassium Nitrate 11 CalciumBP Potassium Nitrate 12 IronBP Potassium Nitrate 13 sodiumBP Potassium Nitrate 14 heavy metalsBP Potassium Nitrate 15 Loss on DryingBP Potassium Nitrate 16 AssayBP Potassium Sorbate 1 AppearanceBP Potassium Sorbate 2 SolubilityBP Potassium Sorbate 3 Identification ABP Potassium Sorbate 4 Identification BBP Potassium Sorbate 5 Identification CBP Potassium Sorbate 6 Identification DBP Potassium Sorbate 7 Appearance of solutionBP Potassium Sorbate 8 Acidity or alkalinityBP Potassium Sorbate 9 AldehydesBP Potassium Sorbate 10 Heavy MetalsBP Potassium Sorbate 11 Loss on dryingBP Potassium Sorbate 12 AssayBP Potassium Sulfate 1 AppearanceBP Potassium Sulfate 2 SolubilityBP Potassium Sulfate 3 Identification ABP Potassium Sulfate 4 Identification BBP Potassium Sulfate 5 Appearance of solutionBP Potassium Sulfate 6 Acidity or alkalinityBP Potassium Sulfate 7 ChloridesBP Potassium Sulfate 8 CalciumBP Potassium Sulfate 9 IronBP Potassium Sulfate 10 MagnesiumBP Potassium Sulfate 11 sodiumBP Potassium Sulfate 12 Heavy MetalsBP Potassium Sulfate 13 Loss on DryingBP Potassium Sulfate 14 AssayBP Povidone 1 AppearanceBP Povidone 2 SolubilityBP Povidone 3 Identification ABP Povidone 4 Identification BBP Povidone 5 Identification CBP Povidone 6 Identification DBP Povidone 7 Identification EBP Povidone 8 Appearance of solutionBP Povidone 9 pH (25 °C)BP Povidone 10 ViscosityBP Povidone 11 AldehydesBP Povidone 12 Peroxides

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 83 of 181

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Monograph Name ANALYTETest NumberBP Povidone 14 Hydrazine

BP Povidone 15 Heavy MetalsBP Povidone 16 Sulphated AshBP Povidone 17 WaterBP Povidone 18 AssayBP Povidone 13 Formic AcidBP Povidone-Iodine Solution 1 CharacteristicsBP Povidone-Iodine Solution 2 Identification ABP Povidone-Iodine Solution 3 Identification BBP Povidone-Iodine Solution 4 Identification CBP Povidone-Iodine Solution 5 Identification DBP Povidone-Iodine Solution 6 AcidityBP Povidone-Iodine Solution 7 IodideBP Povidone-Iodine Solution 8 AssayBP Prilocaine 1 AppearanceBP Prilocaine 2 SolubilityBP Prilocaine 3 IdentificationBP Prilocaine 4 Appearance of solutionBP Prilocaine 6 Heavy MetalsBP Prilocaine 7 WaterBP Prilocaine 8 Sulfated AshBP Prilocaine 9 AssayBP Prilocaine 5 Related SubstancesBP Prilocaine 5 unspecified impuritiesBP Prilocaine 5 TotalBP Prilocaine 5 Impurity B

Loss on drying

Identification D

Acid-insoluble ash

AshBP Proline 1 CharactersBP Proline 2 Identification ABP Proline 3 Identification BBP Proline 4 Identification CBP Proline 5 Appearance of SolutionBP Proline 6 Specific Optical RotationBP Proline 7 Ninhydrin Positive SubstancesBP Proline 8 ChloridesBP Proline 9 SulfatesBP Proline 10 AmmoniaBP Proline 11 IronBP Proline 12 Heavy MetalsBP Proline 13 Loss on DryingBP Proline 14 Sulfated AshBP Proline 15 AssayBP Propanol 1 CharactersBP Propanol 2 Identification ABP Propanol 3 Identification BBP Propanol 4 Identification C

BP Processed White Peony Root for use in THMPBP Processed White Peony Root for use in THMPBP Processed White Peony Root for use in THMPBP Processed White Peony Root for use in THMP

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 84 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Propanol 5 Identification D

BP Propanol 6 Appearance (Tests)BP Propanol 7 Acidity or alkalinityBP Propanol 8 AbsorbanceBP Propanol 9 Reducing SubstancesBP Propanol 11 Non-volatile matterBP Propanol 12 WaterBP Propanol (Related substances) 10 Related SubstancesBP Propanol (Related substances) 10 Any impurityBP Propanol (Related substances) 10 TotalBP Propyl Hydroxybenzoate 1 AppearanceBP Propyl Hydroxybenzoate 2 SolubilityBP Propyl Hydroxybenzoate 3 Identification ABP Propyl Hydroxybenzoate 4 Identification BBP Propyl Hydroxybenzoate 5 Identification CBP Propyl Hydroxybenzoate 6 Appearance of solutionBP Propyl Hydroxybenzoate 7 AcidityBP Propyl Hydroxybenzoate 9 Sulfated Ash

8 Related Substances

8 Impurity A

8 unspecified impurities

8 Disregard limit

8 Total

10 AssayBP Propylene Glycol 1 CharactersBP Propylene Glycol 2 Identification ABP Propylene Glycol 3 Identification BBP Propylene Glycol 4 Identification CBP Propylene Glycol 5 Identification DBP Propylene Glycol 6 Appearance (Tests)BP Propylene Glycol 7 Relative densityBP Propylene Glycol 8 Refractive indexBP Propylene Glycol 9 AcidityBP Propylene Glycol 10 Oxidising SubstancesBP Propylene Glycol 11 Reducing SubstancesBP Propylene Glycol 12 Heavy MetalsBP Propylene Glycol 13 WaterBP Propylene Glycol 14 Sulfated AshBP Propylene Glycol Monolaurate 1 AppearanceBP Propylene Glycol Monolaurate 2 SolubilityBP Propylene Glycol Monolaurate 3 Identification ABP Propylene Glycol Monolaurate 5 Acid ValueBP Propylene Glycol Monolaurate 6 Iodine ValueBP Propylene Glycol Monolaurate 7 Saponification ValueBP Propylene Glycol Monolaurate 9 WaterBP Propylene Glycol Monolaurate 10 Total Ash

BP Propyl Hydroxybenzoate (Assay and/or Related substances)BP Propyl Hydroxybenzoate (Assay and/or Related substances)BP Propyl Hydroxybenzoate (Assay and/or Related substances)BP Propyl Hydroxybenzoate (Assay and/or Related substances)BP Propyl Hydroxybenzoate (Assay and/or Related substances)BP Propyl Hydroxybenzoate (Assay and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 85 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

4 Identification B

8 Composition of fatty acids

8 Myristic acid

8 Lauric acid

8 Capric acid

8 Caprylic acid

8 Palmitic acidBP Propylene Glycol Monopalmitostearate 1 AppearanceBP Propylene Glycol Monopalmitostearate 2 SolubilityBP Propylene Glycol Monopalmitostearate 3 Identification ABP Propylene Glycol Monopalmitostearate 4 Melting pointBP Propylene Glycol Monopalmitostearate 5 Acid ValueBP Propylene Glycol Monopalmitostearate 6 Iodine ValueBP Propylene Glycol Monopalmitostearate 7 Saponification ValueBP Propylene Glycol Monopalmitostearate 10 Total Ash

9 Free propylene glycol

11 Assay

4 Identification B

8 Composition of fatty acids

8

8 Stearic acidBP Pseudoephedrine Hydrochloride 1 AppearanceBP Pseudoephedrine Hydrochloride 2 SolubilityBP Pseudoephedrine Hydrochloride 3 Melting pointBP Pseudoephedrine Hydrochloride 4 Identification ABP Pseudoephedrine Hydrochloride 5 Identification BBP Pseudoephedrine Hydrochloride 6 Identification CBP Pseudoephedrine Hydrochloride 7 Identification DBP Pseudoephedrine Hydrochloride 8 Appearance of solutionBP Pseudoephedrine Hydrochloride 9 Acidity or alkalinityBP Pseudoephedrine Hydrochloride 10 Specific Optical RotationBP Pseudoephedrine Hydrochloride 12 Loss on DryingBP Pseudoephedrine Hydrochloride 13 Sulfated AshBP Pseudoephedrine Hydrochloride 14 Assay

11 Related Substances

11 Sum of impurities other than A

11 Any other impurity

BP Propylene Glycol Monolaurate (Composition of fatty acids)BP Propylene Glycol Monolaurate (Composition of fatty acids)BP Propylene Glycol Monolaurate (Composition of fatty acids)BP Propylene Glycol Monolaurate (Composition of fatty acids)BP Propylene Glycol Monolaurate (Composition of fatty acids)BP Propylene Glycol Monolaurate (Composition of fatty acids)BP Propylene Glycol Monolaurate (Composition of fatty acids)

BP Propylene Glycol Monopalmitostearate (Assay and/or Free propylene glycol)BP Propylene Glycol Monopalmitostearate (Assay and/or Free propylene glycol)BP Propylene Glycol Monopalmitostearate (ID B and/or Composition of fatty acids)BP Propylene Glycol Monopalmitostearate (ID B and/or Composition of fatty acids)BP Propylene Glycol Monopalmitostearate (ID B and/or Composition of fatty acids)

Sum of contents of palmitic acid and stearic acid

BP Propylene Glycol Monopalmitostearate (ID B and/or Composition of fatty acids)

BP Pseudoephedrine Hydrochloride (Related substances)BP Pseudoephedrine Hydrochloride (Related substances)BP Pseudoephedrine Hydrochloride (Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 86 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

11 Impurity ABP Purified Talc 1 AppearanceBP Purified Talc 2 SolubilityBP Purified Talc 3 Identification ABP Purified Talc 4 Identification BBP Purified Talc 5 Identification CBP Purified Talc 6 Solution S1BP Purified Talc 7 Solution S2BP Purified Talc 8 Acidity or alkalinityBP Purified Talc 9 Water soluble substancesBP Purified Talc 10 Loss on ignitionBP Purified Water 1 Total Organic CarbonBP Purified Water 2 ConductivityBP Purified Water 3 AppearanceBP Purified Water 4 NitratesBP Purified Water 5 AluminiumBP Purified Water 6 Heavy MetalsBP Purified Water 7 Acidity or alkalinityBP Purified Water 8 Oxidisable substancesBP Purified Water 9 ChloridesBP Purified Water 10 SulfatesBP Purified Water 11 AmmoniumBP Purified Water 12 Calcium and magnesiumBP Purified Water 13 Residue on evaporationBP Pygeum Bark 1 Identification CBP Pygeum Bark 2 Foreign MatterBP Pygeum Bark 3 Loss on DryingBP Pygeum Bark 4 Total AshBP Pygeum Bark 5 Extractable MatterBP Pyrantel Embonate 1 AppearanceBP Pyrantel Embonate 2 SolubilityBP Pyrantel Embonate 3 IdentificationBP Pyrantel Embonate 4 Related SubstancesBP Pyrantel Embonate 4 Impurity ABP Pyrantel Embonate 4 Impurity BBP Pyrantel Embonate 4 Unspecified ImpuritiesBP Pyrantel Embonate 4 Sum of Impurities other than A and BBP Pyrantel Embonate 5 chloridesBP Pyrantel Embonate 6 sulfatesBP Pyrantel Embonate 7 IronBP Pyrantel Embonate 8 Heavy metalsBP Pyrantel Embonate 9 Loss on DryingBP Pyrantel Embonate 10 Sulfated AshBP Pyrantel Embonate 11 AssayBP Pyridoxine Hydrochloride 1 AppearanceBP Pyridoxine Hydrochloride 2 SolubilityBP Pyridoxine Hydrochloride 3 Melting pointBP Pyridoxine Hydrochloride 4 Identification ABP Pyridoxine Hydrochloride 5 Identification BBP Pyridoxine Hydrochloride 6 Identification CBP Pyridoxine Hydrochloride 7 Identification D

BP Pseudoephedrine Hydrochloride (Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 87 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Pyridoxine Hydrochloride 8 Appearance of solution

BP Pyridoxine Hydrochloride 9 pHBP Pyridoxine Hydrochloride 11 Heavy MetalsBP Pyridoxine Hydrochloride 12 Loss on dryingBP Pyridoxine Hydrochloride 13 Sulfated AshBP Pyridoxine Hydrochloride 14 Assay

10 Related Substances

10 unspecified impurities

10 Impurity B

10 Total

BP Qualitative Reactions and Tests Acetates - Test A

BP Qualitative Reactions and Tests Acetates - Test B

BP Qualitative Reactions and Tests Acetyl GroupsBP Qualitative Reactions and Tests Alkaloids AlkaloidsBP Qualitative Reactions and Tests Aluminium Salts

BP Qualitative Reactions and Tests Amines Primary Aromatic

BP Qualitative Reactions and Tests Ammonium Salts

BP Qualitative Reactions and Tests

BP Qualitative Reactions and Tests Antimony Compounds

BP Qualitative Reactions and Tests Barbiturates

BP Qualitative Reactions and Tests Benzoates - Test A

BP Qualitative Reactions and Tests Benzoates - Test B

BP Qualitative Reactions and Tests Benzoates - Test C

BP Qualitative Reactions and Tests Bicarbonates - Test A

BP Qualitative Reactions and Tests Bicarbonates - Test B

BP Qualitative Reactions and Tests Bicarbonates - Test C

BP Pyridoxine Hydrochloride (Related substances)BP Pyridoxine Hydrochloride (Related substances)BP Pyridoxine Hydrochloride (Related substances)BP Pyridoxine Hydrochloride (Related substances)

Acetates - Test A

Acetates - Test BAcetyl Groups

Aluminium Salts

Amines Primary Aromatic

Ammonium Salts

Ammonium Salts and Salts of Volatile Bases

Ammonium Salts and Salts of Volatile Bases

Antimony CompoundsBarbiturates

(Non-nitrogen

substituted) Benzoates -

Test ABenzoates -

Test BBenzoates -

Test CBicarbonates

- Test ABicarbonates

- Test BBicarbonates

- Test C

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 88 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

BP Qualitative Reactions and Tests

BP Qualitative Reactions and Tests

BP Qualitative Reactions and Tests Bromides - Test A

BP Qualitative Reactions and Tests Bromides - Test B

BP Qualitative Reactions and Tests Calcium and Calcium Salts - Test A

BP Qualitative Reactions and Tests Calcium and Calcium Salts - Test B

BP Qualitative Reactions and Tests Calcium and Calcium Salts - Test C

BP Qualitative Reactions and Tests Carbonates - Test A

BP Qualitative Reactions and Tests Carbonates - Test B

BP Qualitative Reactions and Tests Carbonates and Bicarbonates

BP Qualitative Reactions and Tests Chlorides - Test A

BP Qualitative Reactions and Tests Chlorides - Test B

BP Qualitative Reactions and Tests Citrates - Test A

BP Qualitative Reactions and Tests Citrates - Test BBP Qualitative Reactions and Tests Esters EstersBP Qualitative Reactions and Tests Iodides - Test A

BP Qualitative Reactions and Tests Iodides - Test B

BP Qualitative Reactions and Tests Iron and Iron Salts - Test A

BP Qualitative Reactions and Tests Iron and Iron Salts - Test B

BP Qualitative Reactions and Tests Iron and Iron Salts - Test CBP Qualitative Reactions and Tests Lactates Lactates

BP Qualitative Reactions and Tests Lead and Lead Compounds - Test A

Bismuth and Bismuth

Compounds - Test A

Bismuth and Bismuth Compounds - Test A

Bismuth and Bismuth

Compounds - Test B

Bismuth and Bismuth Compounds - Test B

Bromides - Test A

Bromides - Test B

Calcium and Calcium Salts

- Test ACalcium and Calcium Salts

- Test BCalcium and Calcium Salts

- Test CCarbonates -

Test ACarbonates -

Test BCarbonates

and BicarbonatesChlorides -

Test AChlorides -

Test BCitrates -

Test ACitrates -

Test B

Iodides - Test A

Iodides - Test B

Iron and Iron Salts - Test AIron and Iron Salts - Test BIron and Iron Salts - Test C

Lead and Lead

Compounds - Test A

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 89 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

BP Qualitative Reactions and Tests Lead and Lead Compounds - Test B

BP Qualitative Reactions and Tests Lignin - Test A

BP Qualitative Reactions and Tests Lignin - Test B

BP Qualitative Reactions and Tests

BP Qualitative Reactions and Tests

BP Qualitative Reactions and Tests

BP Qualitative Reactions and Tests

BP Qualitative Reactions and Tests Nitrates NitratesBP Qualitative Reactions and Tests Odour Odour

BP Qualitative Reactions and Tests Phosphates (Orthophosphates) - Test A

BP Qualitative Reactions and Tests Phosphates (Orthophosphates) - Test B

BP Qualitative Reactions and Tests Potassium and Potassium Salts - Test A

BP Qualitative Reactions and Tests Potassium and Potassium Salts - Test B

BP Qualitative Reactions and Tests Salicylates - Test A

BP Qualitative Reactions and Tests Salicylates - Test BBP Qualitative Reactions and Tests Silicates Silicates

BP Qualitative Reactions and Tests Silver and Silver Compounds

BP Qualitative Reactions and Tests Sodium and Sodium Salts - Test A

Lead and Lead

Compounds - Test B

Lignin - Test A

Lignin - Test B

Magnesium and

Magnesium Salts - Test A

Magnesium and Magnesium Salts - Test A

Magnesium and

Magnesium Salts - Test B

Magnesium and Magnesium Salts - Test B

Mercury and Mercury

Compounds - Test A

Mercury and Mercury Compounds - Test A

Mercury and Mercury

Compounds - Test B

Mercury and Mercury Compounds - Test B

Phosphates (Orthophosphates) - Test A

Phosphates (Orthophosphates) - Test B

Potassium and

Potassium Salts - Test A

Potassium and

Potassium Salts - Test BSalicylates -

Test ASalicylates -

Test B

Silver and Silver

CompoundsSodium and Sodium Salts

- Test A

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 90 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

BP Qualitative Reactions and Tests Sodium and Sodium Salts - Test B

BP Qualitative Reactions and Tests Sulfates - Test A

BP Qualitative Reactions and Tests Sulfates - Test B

BP Qualitative Reactions and Tests Tartrates - Test A

BP Qualitative Reactions and Tests Tartrates - Test BBP Qualitative Reactions and Tests Xanthines XanthinesBP Qualitative Reactions and Tests Zinc and Zinc SaltsBP Racementhol 1 AppearanceBP Racementhol 2 SolubilityBP Racementhol 3 Melting pointBP Racementhol 4 Identification ABP Racementhol 5 Identification BBP Racementhol 7 Identification DBP Racementhol 8 Appearance of solutionBP Racementhol 9 Acidity or alkalinityBP Racementhol 10 Optical rotationBP Racementhol 12 Residue on evaporation

6 Identification C

11 Total

11 Related SubstancesBP Racemic Camphor 1 AppearanceBP Racemic Camphor 2 SolubilityBP Racemic Camphor 3 Identification ABP Racemic Camphor 4 Identification BBP Racemic Camphor 5 Identification CBP Racemic Camphor 6 Appearance of solutionBP Racemic Camphor 7 Acidity or alkalinityBP Racemic Camphor 8 Optical rotationBP Racemic Camphor 10 HalogensBP Racemic Camphor 11 WaterBP Racemic Camphor 12 Residue on evaporationBP Racemic Camphor (Related substances) 9 Related SubstancesBP Racemic Camphor (Related substances) 9 Any impurityBP Racemic Camphor (Related substances) 9 TotalBP Refined Almond Oil 1 AppearanceBP Refined Almond Oil 2 SolubilityBP Refined Almond Oil 3 Relative densityBP Refined Almond Oil 4 Identification ABP Refined Almond Oil 6 Specific absorbanceBP Refined Almond Oil 7 Acid ValueBP Refined Almond Oil 8 Peroxide ValueBP Refined Almond Oil 9 Unsaponifiable matterBP Refined Almond Oil 11 Water

Sodium and Sodium Salts

- Test BSulfates -

Test ASulfates -

Test BTartrates -

Test ATartrates -

Test B

Zinc and Zinc Salts

BP Racementhol (ID C and/or Related substances)BP Racementhol (ID C and/or Related substances)BP Racementhol (ID C and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 91 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

5 Identification B

10 Composition of fatty acids

10 Erucic acid

10 Behenic acid

10 Eicosenoic acid

10 Arachidic acid

10 Linolenic acid

10 Linoleic Acid

10

10 Palmitic acid

10 Palmitoleic acid

10 Margaric acid

10 Stearic acid

10 Oleic acid

1 Appearance

2 Identification

4 Water

3 Nonivamide

5 Assay

5 Capsaicin

1 Appearance

2 Identification A

4 Loss on drying

5 Total Ash

3 Identification B

6

7

BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)

Saturated fatty acids of chain length less than C16

BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined Almond Oil (ID B and/or Composition of fatty acids)BP Refined and Standardised Capsicum OleoresinBP Refined and Standardised Capsicum OleoresinBP Refined and Standardised Capsicum OleoresinBP Refined and Standardised Capsicum Oleoresin (Nonivamide and/or Assay)BP Refined and Standardised Capsicum Oleoresin (Nonivamide and/or Assay)BP Refined and Standardised Capsicum Oleoresin (Nonivamide and/or Assay)BP Refined and Standardised Fresh Bilberry Fruit Dry ExtractBP Refined and Standardised Fresh Bilberry Fruit Dry ExtractBP Refined and Standardised Fresh Bilberry Fruit Dry ExtractBP Refined and Standardised Fresh Bilberry Fruit Dry ExtractBP Refined and Standardised Fresh Bilberry Fruit Dry Extract (ID B and/or Assay)BP Refined and Standardised Fresh Bilberry Fruit Dry Extract (ID B and/or Assay)

Total anthocyanidins (as cyanidin chloride)

BP Refined and Standardised Fresh Bilberry Fruit Dry Extract (ID B and/or Assay)

Total anthocyanins (as cyanidin 3-O-glucoside chloride)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 92 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

1 Appearance

2 Identification

3 Loss on drying

4 Assay

4 Sum of Silibinin A and Silibinin B

4 Total silymarin

4 Sum of isosilibinin A and isosilibinin B

4 Sum of silicristin and silidianinBP Refined Borage Oil 1 Appearance BP Refined Borage Oil 2 SolubilityBP Refined Borage Oil 3 Relative DensityBP Refined Borage Oil 4 Refractive IndexBP Refined Borage Oil 5 Identification A (TLC)BP Refined Borage Oil 6 Identification B (Fatty Acid Profile)BP Refined Borage Oil 7 Acid ValueBP Refined Borage Oil 8 Peroxide ValueBP Refined Borage Oil 9 Unsaponifiable MatterBP Refined Borage Oil 10 Alkaline ImpuritiesBP Refined Borage Oil 11 Compositionof Fatty AcidsBP Refined Borage Oil 11BP Refined Borage Oil 11 Palmitic AcidBP Refined Borage Oil 11 Palmitoleic AcidBP Refined Borage Oil 11 Stearic AcidBP Refined Borage Oil 11 Oleic AcidBP Refined Borage Oil 11 Linoleic AcidBP Refined Borage Oil 11 gamma-Linolenic AcidBP Refined Borage Oil 11 alpha-Linolenic AcidBP Refined Borage Oil 11 Arachidic AcidBP Refined Borage Oil 11 Eicosenoic AcidBP Refined Borage Oil 11 Erucic AcidBP Refined Borage Oil 11 Nervonic AcidBP Refined Borage Oil 12 BrassicasterolBP Refined Borage Oil 13 WaterBP Refined Castor Oil 1 CharactersBP Refined Castor Oil 2 Relative densityBP Refined Castor Oil 3 Refractive indexBP Refined Castor Oil 4 ViscosityBP Refined Castor Oil 5 Identification ABP Refined Castor Oil 7 Identification BBP Refined Castor Oil 8 Appearance (Tests)BP Refined Castor Oil 9 Optical rotationBP Refined Castor Oil 10 Specific absorbanceBP Refined Castor Oil 11 Acid ValueBP Refined Castor Oil 12 Hydroxyl Value

BP Refined and Standardised Milk Thistle Dry ExtractBP Refined and Standardised Milk Thistle Dry ExtractBP Refined and Standardised Milk Thistle Dry ExtractBP Refined and Standardised Milk Thistle Dry Extract (Assay)BP Refined and Standardised Milk Thistle Dry Extract (Assay)BP Refined and Standardised Milk Thistle Dry Extract (Assay)BP Refined and Standardised Milk Thistle Dry Extract (Assay)BP Refined and Standardised Milk Thistle Dry Extract (Assay)

Saturated Fatty Acid of Chain Length Less than C16

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 93 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Refined Castor Oil 13 Peroxide Value

BP Refined Castor Oil 14 Unsaponifiable matterBP Refined Castor Oil 15BP Refined Castor Oil 17 Water

6 Identification C

16 Composition of fatty acids

16 Eicosenoic acid

16 Linolenic acid

16 Oleic acid and its isomers

16 Palmitic acid

16 Any other fatty acid

16 Ricinoleic acid

16 Stearic acid

16 Linoleic acidBP Refined Evening Primrose Oil 1 AppearanceBP Refined Evening Primrose Oil 2 SolubilityBP Refined Evening Primrose Oil 3 Relative densityBP Refined Evening Primrose Oil 4 Refractive indexBP Refined Evening Primrose Oil 5 Identification ABP Refined Evening Primrose Oil 7 Acid ValueBP Refined Evening Primrose Oil 8 Peroxide ValueBP Refined Evening Primrose Oil 9 Unsaponifiable matterBP Refined Evening Primrose Oil 10 Alkaline ImpuritiesBP Refined Evening Primrose Oil 12 Water

6 Identification B

11 Composition of fatty acids

11 Stearic acid

11 Oleic acid

11 Linoleic Acid

11 gamma-Linolenic acid

11 Palmitic acid

11

11 alpha-Linolenic acidBP Refined Maize Oil 1 Appearance

Oil obtained by extraction and adulteration

BP Refined Castor Oil (ID B and/or Composition of fatty acids)BP Refined Castor Oil (ID B and/or Composition of fatty acids)BP Refined Castor Oil (ID B and/or Composition of fatty acids)BP Refined Castor Oil (ID B and/or Composition of fatty acids)BP Refined Castor Oil (ID B and/or Composition of fatty acids)BP Refined Castor Oil (ID B and/or Composition of fatty acids)BP Refined Castor Oil (ID B and/or Composition of fatty acids)BP Refined Castor Oil (ID B and/or Composition of fatty acids)BP Refined Castor Oil (ID B and/or Composition of fatty acids)BP Refined Castor Oil (ID B and/or Composition of fatty acids)

BP Refined Evening Primrose Oil (ID D and/or composition of fatty acids)BP Refined Evening Primrose Oil (ID D and/or composition of fatty acids)BP Refined Evening Primrose Oil (ID D and/or composition of fatty acids)BP Refined Evening Primrose Oil (ID D and/or composition of fatty acids)BP Refined Evening Primrose Oil (ID D and/or composition of fatty acids)BP Refined Evening Primrose Oil (ID D and/or composition of fatty acids)BP Refined Evening Primrose Oil (ID D and/or composition of fatty acids)BP Refined Evening Primrose Oil (ID D and/or composition of fatty acids)

Saturated fatty acids of chain length less than C16

BP Refined Evening Primrose Oil (ID D and/or composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 94 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Refined Maize Oil 2 Solubility

BP Refined Maize Oil 3 Relative densityBP Refined Maize Oil 4 Refractive indexBP Refined Maize Oil 5 Identification ABP Refined Maize Oil 7 Acid ValueBP Refined Maize Oil 8 Peroxide ValueBP Refined Maize Oil 9 Unsaponifiable matterBP Refined Maize Oil 10 Alkaline ImpuritiesBP Refined Maize Oil 12 Water

6 Identification B

11 Composition of fatty acids

11 Linolenic acid

11 Arachidic acid

11 Eicosenoic acid

11 Behenic acid

11 Oleic acid

11 Stearic acid

11 Linoleic acid

11 Other Fatty Acids

11 Fatty acids of chain length less than C16

11 Palmitic acidBP Refined Olive Oil 1 AppearanceBP Refined Olive Oil 2 SolubilityBP Refined Olive Oil 3 Relative densityBP Refined Olive Oil 4 Identification ABP Refined Olive Oil 5 Identification BBP Refined Olive Oil 6 Specific absorbanceBP Refined Olive Oil 7 Acid ValueBP Refined Olive Oil 8 Peroxide ValueBP Refined Olive Oil 9 Unsaponifiable matterBP Refined Olive Oil 10 Alkaline ImpuritiesBP Refined Olive Oil 12 Sesame OilBP Refined Olive Oil 13 Water

11 Composition of fatty acids

11

11 Palmitic acid

11 Lignoceric acid

BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)BP Refined Maize Oil (ID B and/or Composition of fatty acids)

BP Refined Olive Oil (Composition of fatty acids)BP Refined Olive Oil (Composition of fatty acids)

Saturated fatty acids of chain length less than C16

BP Refined Olive Oil (Composition of fatty acids)BP Refined Olive Oil (Composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 95 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

11 Behenic acid

11 Eicosenoic acid

11 Arachidic acid

11 Linolenic acid

11 Linoleic Acid

11 Oleic acid

11 Palmitoleic acid

11 Stearic acidBP Refined Safflower Oil 1 AppearanceBP Refined Safflower Oil 2 SolubilityBP Refined Safflower Oil 3 Identification ABP Refined Safflower Oil 5 Acid ValueBP Refined Safflower Oil 6 Peroxide ValueBP Refined Safflower Oil 7 Unsaponifiable matterBP Refined Safflower Oil 8 Alkaline ImpuritiesBP Refined Safflower Oil 10 Water

4 Identification B

9 Composition of fatty acids

9 Linoleic Acid

9 Palmitic acid

9 Myristic acid

9

9 Behenic acid

9 Eicosenoic acid

9 Arachidic acid

9 Linolenic acid

9 Stearic acid

9 Oleic acidBP Refined Sesame Oil 1 AppearanceBP Refined Sesame Oil 2 SolubilityBP Refined Sesame Oil 3 Relative densityBP Refined Sesame Oil 4 Refractive indexBP Refined Sesame Oil 5 Identification BBP Refined Sesame Oil 6 Acid Value

BP Refined Olive Oil (Composition of fatty acids)BP Refined Olive Oil (Composition of fatty acids)BP Refined Olive Oil (Composition of fatty acids)BP Refined Olive Oil (Composition of fatty acids)BP Refined Olive Oil (Composition of fatty acids)BP Refined Olive Oil (Composition of fatty acids)BP Refined Olive Oil (Composition of fatty acids)BP Refined Olive Oil (Composition of fatty acids)

BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)

Saturated fatty acids of chain length less than C14

BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)BP Refined Safflower Oil (ID B and/or Composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 96 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Refined Sesame Oil 7 Peroxide Value

BP Refined Sesame Oil 8 Unsaponifiable matterBP Refined Sesame Oil 9 Alkaline ImpuritiesBP Refined Sesame Oil 10 Cottonseed oilBP Refined Sesame Oil 11 WaterBP Refined Soya Oil 1 AppearanceBP Refined Soya Oil 2 SolubilityBP Refined Soya Oil 3 Relative densityBP Refined Soya Oil 4 Refractive indexBP Refined Soya Oil 5 IdentificationBP Refined Soya Oil 6 Acid ValueBP Refined Soya Oil 7 Peroxide ValueBP Refined Soya Oil 8 Unsaponifiable matterBP Refined Soya Oil 9 Alkaline ImpuritiesBP Refined Soya Oil 10 Composition of Fatty AcidsBP Refined Soya Oil 10BP Refined Soya Oil 10 myristic acidBP Refined Soya Oil 10 Palmitic acidBP Refined Soya Oil 10 Palmitoleic acidBP Refined Soya Oil 10 Stearic acidBP Refined Soya Oil 10 oleic acidBP Refined Soya Oil 10 Linoleic AcidBP Refined Soya Oil 10 Linolenic acidBP Refined Soya Oil 10 Arachidic acidBP Refined Soya Oil 10 Eicosenoic acidBP Refined Soya Oil 10 Behenic acidBP Refined Soya Oil 11 BrassicasterolBP Refined Soya Oil 12 WaterBP Refined Sunflower Oil 1 AppearanceBP Refined Sunflower Oil 2 SolubilityBP Refined Sunflower Oil 3 Relative densityBP Refined Sunflower Oil 4 Refractive indexBP Refined Sunflower Oil 5 IdentificationBP Refined Sunflower Oil 6 Acid ValueBP Refined Sunflower Oil 7 Peroxide ValueBP Refined Sunflower Oil 8 Unsaponifiable matterBP Refined Sunflower Oil 9 Alkaline ImpuritiesBP Refined Sunflower Oil 11 Water

10 Composition of fatty acids

10 Palmitic acid

10 Oleic acid

10 Linoleic Acid

10 Stearic acidBP Refined Wheat-germ Oil 1 AppearanceBP Refined Wheat-germ Oil 2 SolubilityBP Refined Wheat-germ Oil 3 Relative densityBP Refined Wheat-germ Oil 4 Refractive index

saturated fatty acids of chain length less than C:14

BP Refined Sunflower Oil (composition of fatty acids)BP Refined Sunflower Oil (composition of fatty acids)BP Refined Sunflower Oil (composition of fatty acids)BP Refined Sunflower Oil (composition of fatty acids)BP Refined Sunflower Oil (composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 97 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Refined Wheat-germ Oil 5 Identification A

BP Refined Wheat-germ Oil 6 Identification BBP Refined Wheat-germ Oil 7 Acid ValueBP Refined Wheat-germ Oil 8 Peroxide ValueBP Refined Wheat-germ Oil 9 Unsaponifiable matterBP Refined Wheat-germ Oil 10 Alkaline ImpuritiesBP Refined Wheat-germ Oil 11 Composition of fatty acidsBP Refined Wheat-germ Oil 11 Palmitic acidBP Refined Wheat-germ Oil 11 Oleic acidBP Refined Wheat-germ Oil 11 Eicosenoic acidBP Refined Wheat-germ Oil 11 Stearic acidBP Refined Wheat-germ Oil 11 Linoleic AcidBP Refined Wheat-germ Oil 11 Linolenic acidBP Refined Wheat-germ Oil 12 Water

Residual ethylene oxide and dioxanBP Residual Solvents Residual SolventsBP Residual Solvents EthanolBP Residual Solvents TolueneBP Residual Solvents DichloromethaneBP Residual Solvents ChloroformBP Residual Solvents Ethyl acetateBP Residual Solvents Carbon TetrachlorideBP Residual Solvents AcetoneBP Residual Solvents BenzeneBP Residual Solvents HexaneBP Residual Solvents 1,4-DioxaneBP Residual Solvents AcetonitrileBP Residual Solvents CyclohexaneBP Residual Solvents Methyl isobutyl ketoneBP Residual Solvents 1,1-DichloroetheneBP Residual Solvents PropanolBP Residual Solvents Ethylene glycolBP Residual Solvents 2-ButoxyethanolBP Residual Solvents HeptaneBP Residual Solvents Isopropyl acetateBP Residual Solvents 2-PropanolBP Residual Solvents DimethylformamideBP Residual Solvents triisopropylsilaneBP Residual Solvents Diethyl EtherBP Residual Solvents Methylene chlorideBP Residual Solvents XyleneBP Residual Solvents 1,2-DichloroethaneBP Residual Solvents 1,1,1-TrichloroethaneBP Residual Solvents Methyl Ethyl KetoneBP Residual Solvents MethanolBP Resorcinol 1 CharactersBP Resorcinol 2 Identification ABP Resorcinol 3 Identification BBP Resorcinol 4 Identification CBP Resorcinol 5 Appearance of solutionBP Resorcinol 6 Acidity or alkalinity

BP Residual Ethylene Oxide and Dioxan (Residual impurities)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 98 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Resorcinol 7 Related substances

BP Resorcinol 8 PyrocatecholBP Resorcinol 9 Loss on DryingBP Resorcinol 10 Sulfated ashBP Resorcinol 11 AsssayBP Riboflavin 1 AppearanceBP Riboflavin 2 SolubilityBP Riboflavin 3 Identification ABP Riboflavin 4 Identification BBP Riboflavin 5 Identification CBP Riboflavin 6 Specific Optical RotationBP Riboflavin 7 AbsorbanceBP Riboflavin 8 Related SubstancesBP Riboflavin 8 TotalBP Riboflavin 8 Impurity DBP Riboflavin 8 Impurity CBP Riboflavin 8 unspecified impuritiesBP Riboflavin 8 Impurity BBP Riboflavin 8 Impurity ABP Riboflavin 9 Loss on DryingBP Riboflavin 10 Sulfated AshBP Riboflavin 11 AssayBP Riboflavin Sodium Phosphate 1 AppearanceBP Riboflavin Sodium Phosphate 2 SolubilityBP Riboflavin Sodium Phosphate 3 Identification ABP Riboflavin Sodium Phosphate 5 Identification CBP Riboflavin Sodium Phosphate 6 Identification DBP Riboflavin Sodium Phosphate 7 pHBP Riboflavin Sodium Phosphate 8 Specific Optical RotationBP Riboflavin Sodium Phosphate 9 Impurity EBP Riboflavin Sodium Phosphate 11 Inorganic phosphateBP Riboflavin Sodium Phosphate 12 Heavy MetalsBP Riboflavin Sodium Phosphate 13 Loss on dryingBP Riboflavin Sodium Phosphate 14 Assay

4 Identification B

10 Related Substances

10 System suitability

10 Impurity D

10 Sum of impurities A, B & CBP Rifampicin 1 AppearanceBP Rifampicin 2 SolubilityBP Rifampicin 3 Identification ABP Rifampicin 4 Identification BBP Rifampicin 5 Identification CBP Rifampicin 6 pHBP Rifampicin 7 Related SubstancesBP Rifampicin 7 Impurity ABP Rifampicin 7 Any other impurity

BP Riboflavin Sodium Phosphate (ID B and/or Related substances)BP Riboflavin Sodium Phosphate (ID B and/or Related substances)BP Riboflavin Sodium Phosphate (ID B and/or Related substances)BP Riboflavin Sodium Phosphate (ID B and/or Related substances)BP Riboflavin Sodium Phosphate (ID B and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 99 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Rifampicin 7 Sum of Impurities other than A

BP Rifampicin 8 Heavy MetalsBP Rifampicin 9 Loss on DryingBP Rifampicin 10 Sulfated AshBP Rifampicin 11 AssayBP Rifampicin Oral Suspension 1 Identification ABP Rifampicin Oral Suspension 2 Identification BBP Rifampicin Oral Suspension 3 AcidityBP Rifampicin Oral Suspension 4 AssayBP Rosemary Oil 1 AppearanceBP Rosemary Oil 2 Identification ABP Rosemary Oil 4 Relative densityBP Rosemary Oil 5 Refractive indexBP Rosemary Oil 6 Optical rotationBP Rosemary Oil 7 Acid Value

3 Identification B

8 Chromatographic Profile

8 P-Cymene

8 Bornyl acetate

8 borneol

8 Limonene

8 beta-Pinene

8 alpha-Pinene

8 Verbenone

8 alpha-Terpineol

8 Camphor

8 Cineole

8 beta-myrcene

8 CampheneBP RRR-Alpha-Tocopherol 1 AppearanceBP RRR-Alpha-Tocopherol 2 SolubilityBP RRR-Alpha-Tocopherol 3 Identification ABP RRR-Alpha-Tocopherol 4 Identification BBP RRR-Alpha-Tocopherol 5 Identification CBP RRR-Alpha-Tocopherol 6 Related SubstancesBP RRR-Alpha-Tocopherol 6 Total limitBP RRR-Alpha-Tocopherol 6 Disregard limitBP RRR-Alpha-Tocopherol 7 AssayBP RRR-Alpha-Tocopheryl Acetate 1 Appearance

BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)BP Rosemary Oil (ID B and/or Chromatography profile)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 100 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP RRR-Alpha-Tocopheryl Acetate 2 Solubility

BP RRR-Alpha-Tocopheryl Acetate 3 Identification ABP RRR-Alpha-Tocopheryl Acetate 4 Identification BBP RRR-Alpha-Tocopheryl Acetate 5 Identification CBP RRR-Alpha-Tocopheryl Acetate 6 Related SubstancesBP RRR-Alpha-Tocopheryl Acetate 6 Total limitBP RRR-Alpha-Tocopheryl Acetate 6 Disregard limitBP RRR-Alpha-Tocopheryl Acetate 7 Assay

1 Identification A

2 Extractable Heavy Metals

3 Residue on evaporation

4 Volatile sulfides

5 Penetrability

6 FragmentationBP Rutoside Trihydrate 1 AppearanceBP Rutoside Trihydrate 2 SolubilityBP Rutoside Trihydrate 3 Identification ABP Rutoside Trihydrate 4 Identification BBP Rutoside Trihydrate 5 Identification CBP Rutoside Trihydrate 6 Identification DBP Rutoside Trihydrate 7 Light - absorbing impuritiesBP Rutoside Trihydrate 8 Substances insoluble in methanolBP Rutoside Trihydrate 10 WaterBP Rutoside Trihydrate 11 Sulfated AshBP Rutoside Trihydrate 12 Assay

9 Related Substances

9 Impurity B

9 Total

9 Impurity C

9 Impurity ABP Saccharin Sodium 1 AppearanceBP Saccharin Sodium 2 SolubilityBP Saccharin Sodium 3 Identification ABP Saccharin Sodium 4 Identification BBP Saccharin Sodium 5 Identification CBP Saccharin Sodium 6 Identification DBP Saccharin Sodium 7 Identification EBP Saccharin Sodium 8 Appearance of solutionBP Saccharin Sodium 9 Acidity or alkalinityBP Saccharin Sodium 10 o-ToluenesulphonamideBP Saccharin Sodium 10 p-ToluenesulphonamideBP Saccharin Sodium 11 Readily carbonisable substances

BP Rubber Closures for Containers for Aqueous Parenteral PreprationBP Rubber Closures for Containers for Aqueous Parenteral PreprationBP Rubber Closures for Containers for Aqueous Parenteral PreprationBP Rubber Closures for Containers for Aqueous Parenteral PreprationBP Rubber Closures for Containers for Aqueous Parenteral PreprationBP Rubber Closures for Containers for Aqueous Parenteral Prepration

BP Rutoside Trihydrate (Related substances)BP Rutoside Trihydrate (Related substances)BP Rutoside Trihydrate (Related substances)BP Rutoside Trihydrate (Related substances)BP Rutoside Trihydrate (Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 101 of 181

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Monograph Name ANALYTETest NumberBP Saccharin Sodium 12 Heavy Metals

BP Saccharin Sodium 13 WaterBP Saccharin Sodium 14 Assay (dried substance)BP Salicylic Acid 1 AppearanceBP Salicylic Acid 2 SolubilityBP Salicylic Acid 3 Identification ABP Salicylic Acid 4 Identification BBP Salicylic Acid 5 Identification CBP Salicylic Acid 6 Appearance of solutionBP Salicylic Acid 7 Related SubstancesBP Salicylic Acid 7 Impurity ABP Salicylic Acid 7 Any other impurityBP Salicylic Acid 7 TotalBP Salicylic Acid 7 Impurity BBP Salicylic Acid 7 Impurity CBP Salicylic Acid 8 ChloridesBP Salicylic Acid 9 SulfatesBP Salicylic Acid 10 Heavy MetalsBP Salicylic Acid 11 Loss on DryingBP Salicylic Acid 12 Sulfated AshBP Salicylic Acid 13 AssayBP Saponification Value Saponification ValueBP Saw Palmetto Fruit 1 CharactersBP Saw Palmetto Fruit 2 Identification CBP Saw Palmetto Fruit 4 Loss on dryingBP Saw Palmetto Fruit 5 Total Ash

3 Identification D

6 Total fatty acidsBP Self-emulsifying Glyceryl Monostearate 1 CharacteristicsBP Self-emulsifying Glyceryl Monostearate 2 Acid ValueBP Self-emulsifying Glyceryl Monostearate 3 Iodine ValueBP Self-emulsifying Glyceryl Monostearate 4 AlkalinityBP Self-emulsifying Glyceryl Monostearate 5 Heavy MetalsBP Self-emulsifying Glyceryl Monostearate 6 WaterBP Self-emulsifying Glyceryl Monostearate 7 Assay For free glycerolBP Self-emulsifying Glyceryl Monostearate 8 Assay For monoglyceridesBP Self-emulsifying Glyceryl Monostearate 9 Assay for soapBP Senega Root 1 CharactersBP Senega Root 2 Identification DBP Senna Leaf 1 CharactersBP Senna Leaf 2 Identification CBP Senna Leaf 3 Identification DBP Senna Leaf 4 Foreign MatterBP Senna Leaf 5 Loss on dryingBP Senna Leaf 6 Total AshBP Senna Leaf 7 Ash insoluble in hydrochloric acidBP Senna Leaf 8 AssayBP Sildenafil Citrate 1 Appearance BP Sildenafil Citrate 2 SolubilityBP Sildenafil Citrate 3 Identification (FTIR)BP Sildenafil Citrate 4 Impurity E (TLC)

BP Saw Palmetto Fruit (ID D and/or Total fatty acids)BP Saw Palmetto Fruit (ID D and/or Total fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 102 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Sildenafil Citrate 5 Related Substances

BP Sildenafil Citrate 5 Impurity ABP Sildenafil Citrate 5 Unspecified ImpuritiesBP Sildenafil Citrate 5 Sum of Unspecified ImpuritiesBP Sildenafil Citrate 5 TotalBP Sildenafil Citrate 6 Heavy Metals (Test C)BP Sildenafil Citrate 7 WaterBP Sildenafil Citrate 8 Sulfated AshBP Sildenafil Citrate 9 AssayBP Silicone - Silicone oil used as a Lubricant 1 AppearanceBP Silicone - Silicone oil used as a Lubricant 2 SolubilityBP Silicone - Silicone oil used as a Lubricant 3 Identification ABP Silicone - Silicone oil used as a Lubricant 4 Identification BBP Silicone - Silicone oil used as a Lubricant 5 Identification CBP Silicone - Silicone oil used as a Lubricant 6 Identification DBP Silicone - Silicone oil used as a Lubricant 7 AcidityBP Silicone - Silicone oil used as a Lubricant 8 ViscosityBP Silicone - Silicone oil used as a Lubricant 9 Mineral oilsBP Silicone - Silicone oil used as a Lubricant 10 Phenylated compoundsBP Silicone - Silicone oil used as a Lubricant 11 Heavy MetalsBP Silicone - Silicone oil used as a Lubricant 12 Volatile matterBP Simeticone 1 AppearanceBP Simeticone 2 SolubilityBP Simeticone 3 Identification ABP Simeticone 4 Identification BBP Simeticone 5 Identification CBP Simeticone 6 AcidityBP Simeticone 7 Defoaming activityBP Simeticone 8 Mineral oilsBP Simeticone 9 Phenylated compoundsBP Simeticone 10 Heavy MetalsBP Simeticone 11 Volatile matterBP Simeticone 12 Assay SilicaBP Simeticone 13 Assay Poly (dimethylsiloxane)BP Sodium Ascorbate 1 AppearanceBP Sodium Ascorbate 2 SolubilityBP Sodium Ascorbate 3 Identification ABP Sodium Ascorbate 4 Identification BBP Sodium Ascorbate 5 Identification CBP Sodium Ascorbate 6 Identification DBP Sodium Ascorbate 7 Appearance of solutionBP Sodium Ascorbate 8 pHBP Sodium Ascorbate 9 Specific Optical RotationBP Sodium Ascorbate 10 Impurity EBP Sodium Ascorbate 12 SulfatesBP Sodium Ascorbate 13 Heavy MetalsBP Sodium Ascorbate 14 Loss on dryingBP Sodium Ascorbate 15 AssayBP Sodium Ascorbate (Related Substances) 11 Related SubstancesBP Sodium Ascorbate (Related Substances) 11 Impurities C, DBP Sodium Ascorbate (Related Substances) 11 unspecified impuritiesBP Sodium Ascorbate (Related Substances) 11 Total of impurities other than C and D

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 103 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Sodium Benzoate 1 Appearance

BP Sodium Benzoate 2 SolubilityBP Sodium Benzoate 3 Identification ABP Sodium Benzoate 4 Identification BBP Sodium Benzoate 5 Appearance of solutionBP Sodium Benzoate 6 Acidity or alkalinityBP Sodium Benzoate 7 Halogenated compoundsBP Sodium Benzoate 8 Determination of ionised chlorineBP Sodium Benzoate 9 Determination of total chlorineBP Sodium Benzoate 10 Heavy MetalsBP Sodium Benzoate 11 AssayBP Sodium Benzoate Loss on dryingBP Sodium Bicarbonate 1 AppearanceBP Sodium Bicarbonate 2 SolubilityBP Sodium Bicarbonate 3 Identification ABP Sodium Bicarbonate 4 Identification BBP Sodium Bicarbonate 5 Identification CBP Sodium Bicarbonate 6 Appearance of solutionBP Sodium Bicarbonate 7 CarbonatesBP Sodium Bicarbonate 8 ChloridesBP Sodium Bicarbonate 9 SulfatesBP Sodium Bicarbonate 10 AmmoniumBP Sodium Bicarbonate 12 CalciumBP Sodium Bicarbonate 13 IronBP Sodium Bicarbonate 14 Heavy MetalsBP Sodium Bicarbonate 15 AssayBP Sodium Chloride 1 AppearanceBP Sodium Chloride 2 SolubilityBP Sodium Chloride 3 Identification ABP Sodium Chloride 4 Identification BBP Sodium Chloride 5 Appearance of solutionBP Sodium Chloride 6 Acidity or alkalinityBP Sodium Chloride 7 BromidesBP Sodium Chloride 8 FerrocyanidesBP Sodium Chloride 9 IodidesBP Sodium Chloride 10 NitritesBP Sodium Chloride 11 PhosphatesBP Sodium Chloride 12 SulphatesBP Sodium Chloride 13 AluminiumBP Sodium Chloride 15 BariumBP Sodium Chloride 16 IronBP Sodium Chloride 17 Magnesium and alkaline-earth metalsBP Sodium Chloride 18 PotassiumBP Sodium Chloride 19 Heavy MetalsBP Sodium Chloride 20 Loss on dryingBP Sodium Chloride 21 Assay (dried substance)BP Sodium Chloride Solution 1 Identification ABP Sodium Chloride Solution 2 Identification BBP Sodium Chloride Solution 3 AssayBP Sodium Citrate 1 AppearanceBP Sodium Citrate 2 SolubilityBP Sodium Citrate 3 Identification A

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 104 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Sodium Citrate 4 Identification B

BP Sodium Citrate 5 Appearance of solutionBP Sodium Citrate 6 Acidity or alkalinityBP Sodium Citrate 7 Readily carbonisable substancesBP Sodium Citrate 8 ChloridesBP Sodium Citrate 9 OxalatesBP Sodium Citrate 10 SulphatesBP Sodium Citrate 11 Heavy MetalsBP Sodium Citrate 12 WaterBP Sodium Citrate 14 AssayBP Sodium Cyclamate 1 AppearanceBP Sodium Cyclamate 2 SolubilityBP Sodium Cyclamate 3 Identification ABP Sodium Cyclamate 4 Identification BBP Sodium Cyclamate 5 Identification CBP Sodium Cyclamate 6 Identification DBP Sodium Cyclamate 7 Identification EBP Sodium Cyclamate 8 Appearance of solutionBP Sodium Cyclamate 9 pHBP Sodium Cyclamate 10 AbsorbanceBP Sodium Cyclamate 11 Impurity ABP Sodium Cyclamate 12 Impurities B, C and DBP Sodium Cyclamate 12BP Sodium Cyclamate 12BP Sodium Cyclamate 13 SulfatesBP Sodium Cyclamate 14 Heavy MetalsBP Sodium Cyclamate 15 Loss on DryingBP Sodium Cyclamate 16 Assay

1 Appearance

2 Solubility

3 Identification A

4 Identification B

5 Identification C

6 Appearance of solution

7 pH

8 Reducing Substances

9 Chlorides

10 Sulfates

11 Iron

12 Heavy Metals

BP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate Dihydrate

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 105 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

13 Loss on Drying

14 Assay (dried substance)BP Sodium Fluoride 1 AppearanceBP Sodium Fluoride 2 SolubilityBP Sodium Fluoride 3 Identification ABP Sodium Fluoride 4 Identification BBP Sodium Fluoride 5 Identification CBP Sodium Fluoride 6 Appearance of solutionBP Sodium Fluoride 7 Acidity or alkalinityBP Sodium Fluoride 8 ChloridesBP Sodium Fluoride 9 FluorosilicatesBP Sodium Fluoride 10 SulfatesBP Sodium Fluoride 11 Loss on DryingBP Sodium Fluoride 12 AssayBP Sodium Hydroxide 1 AppearanceBP Sodium Hydroxide 2 SolubilityBP Sodium Hydroxide 3 Identification ABP Sodium Hydroxide 4 Identification BBP Sodium Hydroxide 5 Appearance of solutionBP Sodium Hydroxide 6 CarbonatesBP Sodium Hydroxide 7 ChloridesBP Sodium Hydroxide 8 SulfatesBP Sodium Hydroxide 9 IronBP Sodium Hydroxide 10 Heavy MetalsBP Sodium Hydroxide 11 AssayBP Sodium Hydroxide VS Standardisation of 0.01M solutionBP Sodium Hydroxide VS Standardisation of 1M solutionBP Sodium Hydroxide VS Standardisation of 0.1M solutionBP Sodium Iodide 1 AppearanceBP Sodium Iodide 2 SolubilityBP Sodium Iodide 3 Identification ABP Sodium Iodide 4 Identification BBP Sodium Iodide 5 Appearance of solutionBP Sodium Iodide 6 AlkalinityBP Sodium Iodide 7 IodatesBP Sodium Iodide 8 SulfatesBP Sodium Iodide 9 ThiosulfatesBP Sodium Iodide 10 IronBP Sodium Iodide 11 Heavy MetalsBP Sodium Iodide 12 Loss on DryingBP Sodium Iodide 13 AssayBP Sodium Iodide Injection 1 AppearanceBP Sodium Iodide Injection 2 Identification ABP Sodium Iodide Injection 3 Identification BBP Sodium Iodide Injection 4 AssayBP Sodium Lactate Solution 1 AppearanceBP Sodium Lactate Solution 2 SolubilityBP Sodium Lactate Solution 3 Identification ABP Sodium Lactate Solution 4 Identification BBP Sodium Lactate Solution 5 Appearance of solutionBP Sodium Lactate Solution 6 pH

BP Sodium Dihydrogen Phosphate DihydrateBP Sodium Dihydrogen Phosphate Dihydrate

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 106 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Sodium Lactate Solution 7 Reducing sugars and sucrose

BP Sodium Lactate Solution 9 ChloridesBP Sodium Lactate Solution 10 Oxalates and phosphatesBP Sodium Lactate Solution 11 SulfatesBP Sodium Lactate Solution 12 BariumBP Sodium Lactate Solution 13 IronBP Sodium Lactate Solution 14 Heavy MetalsBP Sodium Lactate Solution 15 AssayBP Sodium Lactate Solution 8 MethanolBP Sodium Lauryl Sulfate 1 AppearanceBP Sodium Lauryl Sulfate 2 SolubilityBP Sodium Lauryl Sulfate 3 Identification ABP Sodium Lauryl Sulfate 4 Identification BBP Sodium Lauryl Sulfate 5 Identification CBP Sodium Lauryl Sulfate 6 Identification DBP Sodium Lauryl Sulfate 7 AlkalinityBP Sodium Lauryl Sulfate 8 Non-esterified alcoholsBP Sodium Lauryl Sulfate 9 Sodium chloride and sodium sulfateBP Sodium Lauryl Sulfate 10 Sodium ChlorideBP Sodium Lauryl Sulfate 11 Sodium SulfateBP Sodium Lauryl Sulfate 12 AssayBP Sodium Metabisulfite 1 AppearanceBP Sodium Metabisulfite 2 SolubilityBP Sodium Metabisulfite 3 Identification ABP Sodium Metabisulfite 4 Identification BBP Sodium Metabisulfite 5 Identification CBP Sodium Metabisulfite 6 Appearance of solutionBP Sodium Metabisulfite 7 pHBP Sodium Metabisulfite 8 ThiosulfatesBP Sodium Metabisulfite 9 IronBP Sodium Metabisulfite 10 Heavy MetalsBP Sodium Metabisulfite 11 AssayBP Sodium Methyl Hydroxybenzoate 1 AppearanceBP Sodium Methyl Hydroxybenzoate 2 SolubilityBP Sodium Methyl Hydroxybenzoate 3 Identification ABP Sodium Methyl Hydroxybenzoate 4 Identification BBP Sodium Methyl Hydroxybenzoate 5 Identification CBP Sodium Methyl Hydroxybenzoate 6 Appearance of solutionBP Sodium Methyl Hydroxybenzoate 7 pHBP Sodium Methyl Hydroxybenzoate 8 Related SubstancesBP Sodium Methyl Hydroxybenzoate 8 unspecified impuritiesBP Sodium Methyl Hydroxybenzoate 8 Impurity ABP Sodium Methyl Hydroxybenzoate 8 Sum of impurities other than ABP Sodium Methyl Hydroxybenzoate 9 ChloridesBP Sodium Methyl Hydroxybenzoate 10 SulfatesBP Sodium Methyl Hydroxybenzoate 11 Heavy MetalsBP Sodium Methyl Hydroxybenzoate 12 WaterBP Sodium Methyl Hydroxybenzoate 13 AssayBP Sodium Nitrite 1 AppearanceBP Sodium Nitrite 2 SolubilityBP Sodium Nitrite 3 Identification ABP Sodium Nitrite 4 Identification B

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 107 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Sodium Nitrite 5 Identification C

BP Sodium Nitrite 6 Appearance of solutionBP Sodium Nitrite 7 Acidity or alkalinityBP Sodium Nitrite 8 ChloridesBP Sodium Nitrite 9 SulfatesBP Sodium Nitrite 10 Heavy MetalsBP Sodium Nitrite 11 Loss on DryingBP Sodium Nitrite 12 AssayBP Sodium Picosulfate 1 AppearanceBP Sodium Picosulfate 2 SolubilityBP Sodium Picosulfate 3 Identification ABP Sodium Picosulfate 4 Identification BBP Sodium Picosulfate 5 Identification CBP Sodium Picosulfate 6 Identification DBP Sodium Picosulfate 7 Appearance of solutionBP Sodium Picosulfate 8 Acidity or alkalinityBP Sodium Picosulfate 10 ChloridesBP Sodium Picosulfate 11 SulfatesBP Sodium Picosulfate 12 WaterBP Sodium Picosulfate 13 AssayBP Sodium Picosulfate (Related substances) 9 Related SubstancesBP Sodium Picosulfate (Related substances) 9 unspecified impuritiesBP Sodium Picosulfate (Related substances) 9 Impurities A, BBP Sodium Picosulfate (Related substances) 9 TotalBP Sodium Salicylate 1 AppearanceBP Sodium Salicylate 2 SolubilityBP Sodium Salicylate 3 Identification ABP Sodium Salicylate 4 Identification BBP Sodium Salicylate 5 Identification CBP Sodium Salicylate 6 Appearance of solutionBP Sodium Salicylate 7 AcidityBP Sodium Salicylate 8 ChloridesBP Sodium Salicylate 9 SulfatesBP Sodium Salicylate 10 Heavy MetalsBP Sodium Salicylate 11 Loss on DryingBP Sodium Salicylate 12 AssayBP Sodium Starch Glycolate (Type A) 1 AppearanceBP Sodium Starch Glycolate (Type A) 2 SolubilityBP Sodium Starch Glycolate (Type A) 3 Identification ABP Sodium Starch Glycolate (Type A) 4 Identification BBP Sodium Starch Glycolate (Type A) 5 Identification CBP Sodium Starch Glycolate (Type A) 6 Identification DBP Sodium Starch Glycolate (Type A) 7 Appearance of solutionBP Sodium Starch Glycolate (Type A) 8 pHBP Sodium Starch Glycolate (Type A) 9 Sodium glycolateBP Sodium Starch Glycolate (Type A) 10 Sodium ChlorideBP Sodium Starch Glycolate (Type A) 11 IronBP Sodium Starch Glycolate (Type A) 12 Loss on dryingBP Sodium Starch Glycolate (Type A) 13 AssayBP Sodium Sulfate 1 AppearanceBP Sodium Sulfate 2 SolubilityBP Sodium Sulfate 3 Identification A

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 108 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Sodium Sulfate 4 Identification B

BP Sodium Sulfate 5 Identification CBP Sodium Sulfate 6 Appearance of solutionBP Sodium Sulfate 7 Acidity or alkalinityBP Sodium Sulfate 8 ChloridesBP Sodium Sulfate 9 CalciumBP Sodium Sulfate 10 IronBP Sodium Sulfate 11 Heavy MetalsBP Sodium Sulfate 12 Loss on DryingBP Sodium Sulfate 13 Assay (dried substance)BP Sorbitan Oleate 1 AppearanceBP Sorbitan Oleate 2 SolubilityBP Sorbitan Oleate 3 Relative densityBP Sorbitan Oleate 4 Identification ABP Sorbitan Oleate 5 Identification BBP Sorbitan Oleate 6 Identification CBP Sorbitan Oleate 7 Acid ValueBP Sorbitan Oleate 8 Hydroxyl ValueBP Sorbitan Oleate 9 Iodine ValueBP Sorbitan Oleate 10 Peroxide ValueBP Sorbitan Oleate 11 Saponification ValueBP Sorbitan Oleate 13 Heavy MetalsBP Sorbitan Oleate 14 WaterBP Sorbitan Oleate 15 Total Ash

12 Composition of Fatty Acids

12 Myristic acid

12 Stearic acid

12 Palmitic acid

12 Palmitoleic acid

12 Oleic acidBP Sorbitan Stearate 1 AppearanceBP Sorbitan Stearate 2 SolubilityBP Sorbitan Stearate 3 Identification ABP Sorbitan Stearate 4 Identification BBP Sorbitan Stearate 6 Acid ValueBP Sorbitan Stearate 7 Hydroxyl ValueBP Sorbitan Stearate 8 Peroxide ValueBP Sorbitan Stearate 9 Saponification ValueBP Sorbitan Stearate 11 Heavy MetalsBP Sorbitan Stearate 12 WaterBP Sorbitan Stearate 13 Total Ash

5 Identification C

10 Composition of Fatty Acids

10 Stearic acid 70

BP Sorbitan Oleate (Composition of fatty acids)BP Sorbitan Oleate (Composition of fatty acids)BP Sorbitan Oleate (Composition of fatty acids)BP Sorbitan Oleate (Composition of fatty acids)BP Sorbitan Oleate (Composition of fatty acids)BP Sorbitan Oleate (Composition of fatty acids)

BP Sorbitan Stearate (ID C and/or composition of fatty acids)BP Sorbitan Stearate (ID C and/or composition of fatty acids)BP Sorbitan Stearate (ID C and/or composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 109 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

10

10 Stearic acid 50BP Sorbitol 1 SolubilityBP Sorbitol 2 AppearanceBP Sorbitol 4 Identification BBP Sorbitol 5 Identification CBP Sorbitol 6 Identification DBP Sorbitol 7 Appearance of solutionBP Sorbitol 8 ConductivityBP Sorbitol 9 Reducing SugarsBP Sorbitol 11 WaterBP Sorbitol Conductivity

3 Identification A

10 Related Substances

10 D-Sorbitol (anhydrous substance)

10 D-Glucitol (anhydrous substance)

10 Any impurity

10 Disregard limit

10 Total

11 Assay (anhydrous basis)

12 Assay (as is basis)BP Spray-dried Acacia 1 CharactersBP Spray-dried Acacia 2 Identification BBP Spray-dried Acacia 3 Identification CBP Spray-dried Acacia 4 Glucose and fructoseBP Spray-dried Acacia 5 Starch, dextrin and agarBP Spray-dried Acacia 6 Sterculia gumBP Spray-dried Acacia 7 TanninsBP Spray-dried Acacia 8 TragacanthBP Spray-dried Acacia 9 Loss on dryingBP Spray-dried Acacia 10 Total AshBP Spray-dried Acacia 11 Apparent viscosityBP Squalane 1 AppearanceBP Squalane 2 SolubilityBP Squalane 3 Relative densityBP Squalane 4 Identification ABP Squalane 5 Identification BBP Squalane 6 Identification CBP Squalane 7 AppearanceBP Squalane 8 Refractive indexBP Squalane 9 Acid ValueBP Squalane 10 Iodine Value

BP Sorbitan Stearate (ID C and/or composition of fatty acids)

Sum of contents of palmitic acid and stearic acid

BP Sorbitan Stearate (ID C and/or composition of fatty acids)

BP Sorbitol (ID A and/or Assay and/or Related substances)BP Sorbitol (ID A and/or Assay and/or Related substances)BP Sorbitol (ID A and/or Assay and/or Related substances)BP Sorbitol (ID A and/or Assay and/or Related substances)BP Sorbitol (ID A and/or Assay and/or Related substances)BP Sorbitol (ID A and/or Assay and/or Related substances)BP Sorbitol (ID A and/or Assay and/or Related substances)BP Sorbitol (ID A and/or Assay and/or Related substances)BP Sorbitol (ID A and/or Assay and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 110 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Squalane 11 Saponification Value

BP Squalane 12 Total AshBP Squalane 13 AssayBP Standardised Aloes Dry Extract 1 AppearanceBP Standardised Aloes Dry Extract 2 SolubilityBP Standardised Aloes Dry Extract 3 Identification ABP Standardised Aloes Dry Extract 4 Identification BBP Standardised Aloes Dry Extract 5 Loss on dryingBP Standardised Aloes Dry Extract 6 Total AshBP Standardised Aloes Dry Extract 7 AssayBP Standardised Cascara Dry Extract 2 AppearanceBP Standardised Cascara Dry Extract 2 Identification by TLCBP Standardised Cascara Dry Extract 3 Loss on DryingBP Standardised Cascara Dry Extract 4 AssayBP Standardised Cascara Dry Extract 4BP Standardised Cascara Dry Extract 4 CascarosidesBP Standardised Senna Leaf Dry Extract 1 AppearanceBP Standardised Senna Leaf Dry Extract 2 Identification ABP Standardised Senna Leaf Dry Extract 3 Identification BBP Standardised Senna Leaf Dry Extract 4 Loss on DryingBP Standardised Senna Leaf Dry Extract 5 AssayBP Stannous Chloride Dihydrate 1 AppearanceBP Stannous Chloride Dihydrate 2 SolubilityBP Stannous Chloride Dihydrate 3 Identification ABP Stannous Chloride Dihydrate 4 Identification BBP Stannous Chloride Dihydrate 5 Identification CBP Stannous Chloride Dihydrate 6 Appearance of solutionBP Stannous Chloride Dihydrate 7 Preparation of Solution S2BP Stannous Chloride Dihydrate 8BP Stannous Chloride Dihydrate 9 SulfatesBP Stannous Chloride Dihydrate 10 IronBP Stannous Chloride Dihydrate 11 Heavy MetalsBP Stannous Chloride Dihydrate 12 AssayBP Star Anise Oil 1 AppearanceBP Star Anise Oil 2 Identification ABP Star Anise Oil 2 Results ABP Star Anise Oil 2 Results BBP Star Anise Oil 4 Relative densityBP Star Anise Oil 5 Refractive indexBP Star Anise Oil 6 Freezing PointBP Star Anise Oil 9 Fatty oils and resinified essential oils

3 Identification B

7 Fenchone

8 Pseudoisoeugenyl 2-methylbutyrate

10 Chromatographic Profile

10 trans-anethole

Hydroxyanthracene glycosides other than cascarosides

Substances not precipitated by thioacetamide

BP Star Anise Oil (ID B and/or Chromatographic profile)BP Star Anise Oil (ID B and/or Chromatographic profile)BP Star Anise Oil (ID B and/or Chromatographic profile)BP Star Anise Oil (ID B and/or Chromatographic profile)BP Star Anise Oil (ID B and/or Chromatographic profile)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 111 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

10 foeniculin

10 estragole

10 cis-anethole

10 anisaldehyde

10 Linalol

10 alpha - terpineolBP Stearic Acid 1 AppearanceBP Stearic Acid 2 SolubilityBP Stearic Acid 3 Identification ABP Stearic Acid 4 Identification BBP Stearic Acid 6 Appearance (Test)BP Stearic Acid 7 AcidityBP Stearic Acid 8 Iodine ValueBP Stearic Acid 9 Freezing PointBP Stearic Acid (ID C and/or Assay) 5 Identification CBP Stearic Acid (ID C and/or Assay) 10 AssayBP Strong Ammonia Solution 1 Appearance BP Strong Ammonia Solution 2 SolubilityBP Strong Ammonia Solution 3 Identification ABP Strong Ammonia Solution 4 Identification BBP Strong Ammonia Solution 5 Identification CBP Strong Ammonia Solution 6 Appearance of solutionBP Strong Ammonia Solution 7 Oxidisable SubstancesBP Strong Ammonia Solution 8 Pyridine and Related SubstancesBP Strong Ammonia Solution 9 CarbonatesBP Strong Ammonia Solution 10 ChloridesBP Strong Ammonia Solution 11 SulfatesBP Strong Ammonia Solution 12 IronBP Strong Ammonia Solution 13 Heavy MetalsBP Strong Ammonia Solution 14 Residue on EvaporationBP Strong Ammonia Solution 15 AssayBP Strong Sodium Hypochlorite Solution 1 Total AlkalinityBP Strong Sodium Hypochlorite Solution 2 AssayBP Sucralose 1 AppearanceBP Sucralose 2 SolubilityBP Sucralose 3 Identification ABP Sucralose 4 Identification BBP Sucralose 5 Specific Optical RotationBP Sucralose 6 Impurities H and IBP Sucralose 7 Related SubstancesBP Sucralose 7 Impurities A, B, C, D, E, F, GBP Sucralose 8 Heavy MetalsBP Sucralose 9 WaterBP Sucralose 10 Sulfated AshBP Sucralose (Assay) 11 AssayBP Sucrose 1 AppearanceBP Sucrose 2 Solubility

BP Star Anise Oil (ID B and/or Chromatographic profile)BP Star Anise Oil (ID B and/or Chromatographic profile)BP Star Anise Oil (ID B and/or Chromatographic profile)BP Star Anise Oil (ID B and/or Chromatographic profile)BP Star Anise Oil (ID B and/or Chromatographic profile)BP Star Anise Oil (ID B and/or Chromatographic profile)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 112 of 181

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Monograph Name ANALYTETest NumberBP Sucrose 3 Identification A

BP Sucrose 4 Identification BBP Sucrose 5 Identification CBP Sucrose 6 Appearance of solutionBP Sucrose 7 ConductivityBP Sucrose 8 Specific Optical RotationBP Sucrose 9 Colour valueBP Sucrose 10 DextrinsBP Sucrose 11 Reducing SugarsBP Sucrose 12 SulfitesBP Sucrose 13 Loss on dryingBP Sulfadiazine 1 AppearanceBP Sulfadiazine 2 SolubilityBP Sulfadiazine 3 Identification ABP Sulfadiazine 4 Identification BBP Sulfadiazine 5 Identification CBP Sulfadiazine 6 Identification DBP Sulfadiazine 7 Appearance of SolutionBP Sulfadiazine 8 AcidityBP Sulfadiazine 9 Related SubstancesBP Sulfadiazine 9 Impurities A ,BBP Sulfadiazine 9 Impurity EBP Sulfadiazine 9 Impurity FBP Sulfadiazine 9 Unspecified ImpuritiesBP Sulfadiazine 9 TotalBP Sulfadiazine 10 Heavy MetalsBP Sulfadiazine 11 Loss on DryingBP Sulfadiazine 12 Sulfated AshBP Sulfadiazine 13 AssayBP Sulfadimidine 1 CharactersBP Sulfadimidine 2 Identification ABP Sulfadimidine 3 Identification BBP Sulfadimidine 4 Identification CBP Sulfadimidine 5 Identification DBP Sulfadimidine 6 Appearance of solutionBP Sulfadimidine 7 AcidityBP Sulfadimidine 8 Related SubstancesBP Sulfadimidine 8 Impurities C,D, GBP Sulfadimidine 8 Unspecified ImpuritiesBP Sulfadimidine 8 TotalBP Sulfadimidine 9 Heavy MetalsBP Sulfadimidine 10 Loss on DryingBP Sulfadimidine 11 Sulfated AshBP Sulfadimidine 12 AssayBP Sulfadimidine Injection 1 Identification ABP Sulfadimidine Injection 2 Identification BBP Sulfadimidine Injection 3 AlkalinityBP Sulfadimidine Injection 4 Colour of solutionBP Sulfadimidine Injection 5 Related SubstancesBP Sulfadimidine Injection 6 AssayBP Sulfur for External Use 1 AppearanceBP Sulfur for External Use 2 Solubility

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 113 of 181

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Monograph Name ANALYTETest NumberBP Sulfur for External Use 3 Melting point

BP Sulfur for External Use 4 Identification ABP Sulfur for External Use 5 Identification BBP Sulfur for External Use 6 Appearance of solutionBP Sulfur for External Use 7 OdourBP Sulfur for External Use 8 Acidity or alkalinityBP Sulfur for External Use 9 ChloridesBP Sulfur for External Use 10 SulfatesBP Sulfur for External Use 11 SulfidesBP Sulfur for External Use 12 Sulfated AshBP Sulfur for External Use 13 AssayBP Sulfuric Acid 1 AppearanceBP Sulfuric Acid 2 SolubilityBP Sulfuric Acid 3 Relative densityBP Sulfuric Acid 4 Identification ABP Sulfuric Acid 5 Identification BBP Sulfuric Acid 6 Appearance of solutionBP Sulfuric Acid 7 ChloridesBP Sulfuric Acid 8 NitratesBP Sulfuric Acid 9 IronBP Sulfuric Acid 10 Heavy MetalsBP Sulfuric Acid 11 AssayBP Sweet Orange Oil 1 AppearanceBP Sweet Orange Oil 2 Identification ABP Sweet Orange Oil 4 Relative densityBP Sweet Orange Oil 5 Refractive indexBP Sweet Orange Oil 6 Optical rotationBP Sweet Orange Oil 7 Peroxide ValueBP Sweet Orange Oil 8 Fatty oils and resinified essential oilsBP Sweet Orange Oil 9 BergapteneBP Sweet Orange Oil 11 Residue on evaporation

3 Identification B

10 Chromatographic Profile

10 Linalol

10 Geranial

10 Neral

10 Octanal

10 Limonene

10 beta-Pinene

10 alpha-Pinene

10 Valencene

10 Decanal

BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 114 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

10 beta-Myrcene

10 Sabinene

1 Appearance

2 Solubility

3 Identification

4 Acid Value

5 Peroxide Value

6 AssayBP Tea Tree Oil 1 AppearanceBP Tea Tree Oil 2 Identification ABP Tea Tree Oil 4 Relative densityBP Tea Tree Oil 5 Refractive indexBP Tea Tree Oil 6 Optical rotation

3 Identification B

7 Chromatographic Profile

7 gamma-Terpinene

7 alpha-Terpineol

7 Aromadendrene

7 Terpinolene

7 P-Cymene

7 Cineole

7 alpha-Terpinene

7 alpha-Pinene

7 Sabinene

7 Limonene

7 Terpinen-4-ol

1BP Theobroma Oil 1 CharacteristicsBP Theobroma Oil 2 Acid ValueBP Theobroma Oil 3 Iodine ValueBP Theobroma Oil 4 Melting pointBP Theobroma Oil 5 Refractive index

BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Sweet Orange Oil (ID B and/or Chromatographic profile)BP Synthetic Retinol Concentrate (Oily Form)BP Synthetic Retinol Concentrate (Oily Form)BP Synthetic Retinol Concentrate (Oily Form)BP Synthetic Retinol Concentrate (Oily Form)BP Synthetic Retinol Concentrate (Oily Form)BP Synthetic Retinol Concentrate (Oily Form)

BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Tea Tree Oil (Chromatographic profile and/or ID B)BP Test for Aristolochic Acids in Herbal Drugs

Screening test for aristolochic acids (Method A)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 115 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Theobroma Oil 6 Saponification Value

BP Thiamine Hydrochloride 1 AppearanceBP Thiamine Hydrochloride 2 SolubilityBP Thiamine Hydrochloride 3 Identification ABP Thiamine Hydrochloride 4 Identification BBP Thiamine Hydrochloride 5 Identification CBP Thiamine Hydrochloride 6 Appearance of solutionBP Thiamine Hydrochloride 7 pHBP Thiamine Hydrochloride 9 SulfatesBP Thiamine Hydrochloride 10 Heavy MetalsBP Thiamine Hydrochloride 11 WaterBP Thiamine Hydrochloride 12 Sulfated AshBP Thiamine Hydrochloride 13 Assay (anhydrous substance)BP Thiamine Hydrochloride 13 Assay

8 Related Substances

8 Total

8 Any impurityBP Thiamine Nitrate 1 AppearanceBP Thiamine Nitrate 2 SolubilityBP Thiamine Nitrate 3 Identification ABP Thiamine Nitrate 4 Identification BBP Thiamine Nitrate 5 Identification CBP Thiamine Nitrate 6 Appearance of solutionBP Thiamine Nitrate 7 pHBP Thiamine Nitrate 9 Heavy MetalsBP Thiamine Nitrate 10 Loss on DryingBP Thiamine Nitrate 11 Sulfated AshBP Thiamine Nitrate 12 AssayBP Thiamine Nitrate (Related substances) 8 Related SubstancesBP Thiamine Nitrate (Related substances) 8 TotalBP Thiamine Nitrate (Related substances) 8 Any impurityBP Thioctic Acid 1 AppearanceBP Thioctic Acid 2 SolubilityBP Thioctic Acid 3 Melting pointBP Thioctic Acid 4 IdentificationBP Thioctic Acid 5 Appearance of solutionBP Thioctic Acid 6 Impurity BBP Thioctic Acid 7 Related SubstancesBP Thioctic Acid 7 Impurity ABP Thioctic Acid 7 unspecified impuritiesBP Thioctic Acid 7 TotalBP Thioctic Acid 8 Loss on DryingBP Thioctic Acid 9 Sulfated AshBP Thioctic Acid 10 Assay (dried substance)BP Thyme Oil 1 AppearanceBP Thyme Oil 2 SolubilityBP Thyme Oil 3 Identification ABP Thyme Oil 5 Relative densityBP Thyme Oil 6 Refractive index

BP Thiamine Hydrochloride (Related substances)BP Thiamine Hydrochloride (Related substances)BP Thiamine Hydrochloride (Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 116 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

4 Identification B

7 Chromatographic Profile

7 beta-myrcene

7 Thymol

7 Linalol

7 Carvacrol

7 Terpinen-4-ol

7 P-Cymene

7 gamma-TerpineneBP Thymol 1 AppearanceBP Thymol 2 SolubilityBP Thymol 3 Identification ABP Thymol 4 Identification BBP Thymol 5 Identification CBP Thymol 6 Identification DBP Thymol 7 Appearance of solutionBP Thymol 8 AcidityBP Thymol 10 Residue on evaporationBP Thymol (Related substances) 9 Related SubstancesBP Thymol (Related substances) 9 TotalBP Titanium Dioxide 1 AppearanceBP Titanium Dioxide 2 SolubilityBP Titanium Dioxide 3 Identification ABP Titanium Dioxide 4 Identification BBP Titanium Dioxide 5 Identification CBP Titanium Dioxide 6 Solution S1BP Titanium Dioxide 7 Solution S2BP Titanium Dioxide 8 Appearance of solutionBP Titanium Dioxide 9 Acidity or alkalinityBP Titanium Dioxide 10 Water soluble substancesBP Titanium Dioxide 11 AntimonyBP Titanium Dioxide 12 BariumBP Titanium Dioxide 13 IronBP Titanium Dioxide 14 Heavy MetalsBP Tolnaftate 1 AppearanceBP Tolnaftate 2 SolubilityBP Tolnaftate 3 IdentificationBP Tolnaftate 6 Loss on dryingBP Tolnaftate 7 Sulfated AshBP Tolnaftate 8 AssayBP Tolnaftate (Related substances) 4 Impurity DBP Tolnaftate (Related substances) 5 Related SubstancesBP Tolnaftate (Related substances) 5 unspecified impuritiesBP Tolnaftate (Related substances) 5 Total

BP Thyme Oil (ID B and/or chromatographic profile)BP Thyme Oil (ID B and/or chromatographic profile)BP Thyme Oil (ID B and/or chromatographic profile)BP Thyme Oil (ID B and/or chromatographic profile)BP Thyme Oil (ID B and/or chromatographic profile)BP Thyme Oil (ID B and/or chromatographic profile)BP Thyme Oil (ID B and/or chromatographic profile)BP Thyme Oil (ID B and/or chromatographic profile)BP Thyme Oil (ID B and/or chromatographic profile)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 117 of 181

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Monograph Name ANALYTETest NumberBP Total Solids 1 Total Solids

BP Trehalose Dihydrate 1 AppearanceBP Trehalose Dihydrate 2 SolubilityBP Trehalose Dihydrate 3 Identification ABP Trehalose Dihydrate 4 Identification BBP Trehalose Dihydrate 5 Identification CBP Trehalose Dihydrate 6 Appearance of SolutionBP Trehalose Dihydrate 7 pHBP Trehalose Dihydrate 8 Specific Optical RotationBP Trehalose Dihydrate 9 Related SubstancesBP Trehalose Dihydrate 10 ChloridesBP Trehalose Dihydrate 11 SulfatesBP Trehalose Dihydrate 12 Heavy MetalsBP Trehalose Dihydrate 13 Soluble StarchBP Trehalose Dihydrate 14 WaterBP Trehalose Dihydrate 15 Sulfated AshBP Trehalose Dihydrate 16 AssayBP Trehalose Dihydrate 17BP Trehalose DihydrateBP Triethanolamine 1 AppearanceBP Triethanolamine 2 SolubilityBP Triethanolamine 3 Identification ABP Triethanolamine 4 Identification BBP Triethanolamine 6 Identification DBP Triethanolamine 7 Appearance of solutionBP Triethanolamine 9 Heavy MetalsBP Triethanolamine 10 WaterBP Triethanolamine 11 Sulfated AshBP Triethanolamine 12 Assay

5 Identification C

8 Related Substances

8 Impurity A

8 Total

8 Impurity BBP Trimethoprim 1 AppearanceBP Trimethoprim 2 SolubilityBP Trimethoprim 3 Identification ABP Trimethoprim 4 Identification BBP Trimethoprim 5 Identification CBP Trimethoprim 6 Identification DBP Trimethoprim 7 Appearance of SolutionBP Trimethoprim 8 Related Substances ABP Trimethoprim 8 Any ImpurityBP Trimethoprim 8 TotalBP Trimethoprim 9 Related Substances BBP Trimethoprim 9 Any ImpurityBP Trimethoprim 9 TotalBP Trimethoprim 10 Impurity K

BP Triethanolamine (ID C and/or Related substances)BP Triethanolamine (ID C and/or Related substances)BP Triethanolamine (ID C and/or Related substances)BP Triethanolamine (ID C and/or Related substances)BP Triethanolamine (ID C and/or Related substances)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 118 of 181

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Monograph Name ANALYTETest NumberBP Trimethoprim 11 Heavy Metals

BP Trimethoprim 12 Loss on dryingBP Trimethoprim 13 Sulfated AshBP Trimethoprim 14 AssayBP Tyrosine 1 CharactersBP Tyrosine 2 Identification ABP Tyrosine 3 Identification BBP Tyrosine 4 Identification CBP Tyrosine 5 Identification DBP Tyrosine 6 Identification EBP Tyrosine 7 Appearance of solutionBP Tyrosine 8 Specific Optical RotationBP Tyrosine 9 Ninhydrin-positive substancesBP Tyrosine 10 ChloridesBP Tyrosine 11 SulfatesBP Tyrosine 12 AmmoniumBP Tyrosine 13 IronBP Tyrosine 14 Heavy MetalsBP Tyrosine 15 Loss on DryingBP Tyrosine 16 Sulfated AshBP Tyrosine 17 AssayBP Ubidecarenone 1 AppearanceBP Ubidecarenone 2 SolubilityBP Ubidecarenone 3 Melting pointBP Ubidecarenone 4 Identification ABP Ubidecarenone 8 Sulfated AshBP Ubidecarenone 9 Assay

5 Identification B

6 Related Substances

6 Any impurity

6 Total

7 Impurity F

1 Absorbance

2 Optical Transmittance

3 UV/Vis (Assay)BP Undecenoic Acid 1 AppearanceBP Undecenoic Acid 2 SolubilityBP Undecenoic Acid 3 Identification ABP Undecenoic Acid 4 Identification BBP Undecenoic Acid 5 Identification CBP Undecenoic Acid 6 Identification DBP Undecenoic Acid 7 Peroxide ValueBP Undecenoic Acid 8 Fixed and mineral oilsBP Undecenoic Acid 9 Water-soluble acidsBP Undecenoic Acid 10 Degree of unsaturation

BP Ubidecarenone (ID B and/or Related substances)BP Ubidecarenone (ID B and/or Related substances)BP Ubidecarenone (ID B and/or Related substances)BP Ubidecarenone (ID B and/or Related substances)BP Ubidecarenone (ID B and/or Related substances)BP Ultraviolet and Visible Absorption SpectrophotometryBP Ultraviolet and Visible Absorption SpectrophotometryBP Ultraviolet and Visible Absorption Spectrophotometry

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 119 of 181

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Monograph Name ANALYTETest NumberBP Undecenoic Acid 11 Sulfated Ash

BP Undecenoic Acid 12 AssayBP Uniformity of Weight (Mass) Uniformity of WeightBP Uniformity of Weight (Mass) Average Capsule Fill WeightBP Uniformity of Weight (Mass) Uniformity of Fill WeightBP Uniformity of Weight (Mass) Average Fill WeightBP Uniformity of Weight (Mass) Average weightBP Uniformity of Weight (Mass) Shell WeightBP Uniformity of Weight (Mass) Average tablet weightBP Uniformity of Weight (Mass) Average Capsule WeightBP Uniformity of Weight (Mass) Average Gross WeightBP Unsaponifiable matter Method I Unsaponifiable matterBP Urea 1 AppearanceBP Urea 2 SolubilityBP Urea 3 Identification ABP Urea 4 Identification BBP Urea 5 Identification CBP Urea 6 Identification DBP Urea 7 Appearance of solutionBP Urea 8 AlkalinityBP Urea 9 BiuretBP Urea 10 AmmoniumBP Urea 11 Heavy MetalsBP Urea 12 Loss on dryingBP Urea 13 Sulfated AshBP Urea 14 Assay (dried substance)BP Urea Cream 1 Identification ABP Urea Cream 2 Identification BBP Urea Cream 3 AmmoniaBP Urea Cream 4 AssayBP Valerian 1 Identification CBP Valerian 2 Foreign MatterBP Valerian 3 Loss on DryingBP Valerian 4 Total AshBP Valerian 5 Ash insoluble in hydrochloric acidBP Valerian 6 Essential oil contentBP Valerian 7 Sesquiterpenic acidsBP Valerian 7 Acetoxyvalerenic acidBP Valerian 7 Valerenic acidBP Valerian 7 Total Valerenic acidsBP Valerian 7 Hydroxyvalerenic acidBP Vanillin 1 CharactersBP Vanillin 2 Identification ABP Vanillin 3 Identification BBP Vanillin 4 Identification CBP Vanillin 5 Identification DBP Vanillin 6 Appearance of solutionBP Vanillin 7 Related SubstancesBP Vanillin 8 Reaction with sulfuric acidBP Vanillin 9 Loss on DryingBP Vanillin 10 Sulfated AshBP Vanillin 11 Assay (dried substance)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 120 of 181

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Monograph Name ANALYTETest NumberBP Virgin Castor Oil 1 Appearance

BP Virgin Castor Oil 2 SolubilityBP Virgin Castor Oil 3 Relative densityBP Virgin Castor Oil 4 Refractive indexBP Virgin Castor Oil 5 Identification ABP Virgin Castor Oil 6 Identification BBP Virgin Castor Oil 8 Optical rotationBP Virgin Castor Oil 9 Specific absorbanceBP Virgin Castor Oil 10 Acid ValueBP Virgin Castor Oil 12 Hydroxyl ValueBP Virgin Castor Oil 13 Peroxide ValueBP Virgin Castor Oil 14 Unsaponifiable matterBP Virgin Castor Oil 16 WaterBP Virgin Castor Oil (BP2012) 1 AppearanceBP Virgin Castor Oil (BP2012) 2 SolubilityBP Virgin Castor Oil (BP2012) 3 Relative densityBP Virgin Castor Oil (BP2012) 4 Refractive indexBP Virgin Castor Oil (BP2012) 5 Identification A (Optical Rotation)BP Virgin Castor Oil (BP2012) 6 Identification B (Hydroxyl Value)BP Virgin Castor Oil (BP2012) 7 Identification C (Iodine Value)BP Virgin Castor Oil (BP2012) 8BP Virgin Castor Oil (BP2012) 9 Optical rotationBP Virgin Castor Oil (BP2012) 10 Specific absorbanceBP Virgin Castor Oil (BP2012) 11 Acid ValueBP Virgin Castor Oil (BP2012) 12 Hydroxyl ValueBP Virgin Castor Oil (BP2012) 13 Peroxide ValueBP Virgin Castor Oil (BP2012) 14 Unsaponifiable matterBP Virgin Castor Oil (BP2012) 16 Water

7 Identification C

15 Composition of fatty acids

15 Linoleic acid

15 Palmitic acid

15 Any other fatty acid

15 Ricinoleic acid

15 Eicosenoic acid

15 Linolenic acid

15 Oleic acid and isomers

15 Stearic acid

15 Composition of fatty acids

15 Linoleic acid

Identification D (Composition of Fatty Acids)

BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil (ID C and/or Composition of fatty acids)BP Virgin Castor Oil(ID D and/or Composition of fatty acids) (BP2012)BP Virgin Castor Oil(ID D and/or Composition of fatty acids) (BP2012)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 121 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

15 Palmitic acid

15 Any other fatty acid

15 Ricinoleic acid

15 Eicosenoic acid

15 Linolenic acid

15 Oleic acid and isomers

15 Stearic acidBP Virgin Linseed Oil 1 AppearanceBP Virgin Linseed Oil 2 SolubilityBP Virgin Linseed Oil 3 Relative densityBP Virgin Linseed Oil 4 Refractive indexBP Virgin Linseed Oil 5 Identification ABP Virgin Linseed Oil 6 Identification BBP Virgin Linseed Oil 8 Acid ValueBP Virgin Linseed Oil 9 Iodine ValueBP Virgin Linseed Oil 10 Peroxide ValueBP Virgin Linseed Oil 11 Saponification ValueBP Virgin Linseed Oil 12 Unsaponifiable matterBP Virgin Linseed Oil 13 Water

7 Identification C

12 Composition of fatty acids

12 Fatty Acid less than C16

12 Palmitoleic acid

12 Oleic acid

12 Linolenic acid

12 Palmitic acid

12 Stearic acid

12 Linoleic Acid

12 Arachidic AcidBP Virgin Olive Oil 1 AppearanceBP Virgin Olive Oil 2 SolubilityBP Virgin Olive Oil 3 Relative densityBP Virgin Olive Oil 4 Identification by TLCBP Virgin Olive Oil 5 AbsorbanceBP Virgin Olive Oil 6 Acid ValueBP Virgin Olive Oil 7 Peroxide ValueBP Virgin Olive Oil 8 Unsaponifiable matter

BP Virgin Castor Oil(ID D and/or Composition of fatty acids) (BP2012)BP Virgin Castor Oil(ID D and/or Composition of fatty acids) (BP2012)BP Virgin Castor Oil(ID D and/or Composition of fatty acids) (BP2012)BP Virgin Castor Oil(ID D and/or Composition of fatty acids) (BP2012)BP Virgin Castor Oil(ID D and/or Composition of fatty acids) (BP2012)BP Virgin Castor Oil(ID D and/or Composition of fatty acids) (BP2012)BP Virgin Castor Oil(ID D and/or Composition of fatty acids) (BP2012)

BP Virgin Linseed Oil (Composition of fatty acids)BP Virgin Linseed Oil (Composition of fatty acids)BP Virgin Linseed Oil (Composition of fatty acids)BP Virgin Linseed Oil (Composition of fatty acids)BP Virgin Linseed Oil (Composition of fatty acids)BP Virgin Linseed Oil (Composition of fatty acids)BP Virgin Linseed Oil (Composition of fatty acids)BP Virgin Linseed Oil (Composition of fatty acids)BP Virgin Linseed Oil (Composition of fatty acids)BP Virgin Linseed Oil (Composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 122 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Virgin Olive Oil 10 Sesame Oil

BP Virgin Olive Oil 11 Water9 Composition of fatty acids

9 Eicosenoic acid

9 Linolenic acid

9 Lignoceric acid

9 Palmitic acid

9 Stearic acid

9 Linoleic acid

9 Arachidic acid

9 Behenic acid

9 Palmitoleic acid

9

9 Oleic acidBP Viscosity Viscosity (Method III)BP Viscosity Viscosity (Method I)BP Viscosity Viscosity (Method II)BP Vitamin A 1 AppearanceBP Vitamin A 2 SolubilityBP Vitamin A 3 Identification ABP Vitamin A 4 Identification BBP Vitamin A 5 RetinolBP Vitamin A 6 Related SubstancesBP Vitamin A 6 Absorbance ratio (A370/A326)BP Vitamin A 6 Absorbance ratio (A350/A326)BP Vitamin A 6 Absorbance ratio (A300/A326)BP Vitamin A 7 ActivityBP Water for Injection 1 Total Organic CarbonBP Water for Injections 2 ConductivityBP Water for Injections 3 AppearanceBP Water for Injections 4 NitratesBP Water for Injections 5 AluminiumBP Water for Injections 6 Acidity or alkalinityBP Water for Injections 7 Oxidisable substancesBP Water for Injections 8 ChloridesBP Water for Injections 9 SulfatesBP Water for Injections 10 AmmoniumBP Water for Injections 11 Calcium and magnesiumBP Water for Injections 12 Residue on evaporationBP Wheat Starch 1 AppearanceBP Wheat Starch 2 Solubility

BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)BP Virgin Olive Oil (Composition of fatty acids)

Saturated fatty acids of chain length less than C16

BP Virgin Olive Oil (Composition of fatty acids)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 123 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Wheat Starch 6 pH

BP Wheat Starch 8 Total ProteinBP Wheat Starch 9 Oxidising SubstancesBP Wheat Starch 10 Sulfur DioxideBP Wheat Starch 11 IronBP Wheat Starch 12 Loss on DryingBP Wheat Starch 13 Sulfated AshBP White Beeswax 1 AppearanceBP White Beeswax 2 SolubilityBP White Beeswax 3 Relative densityBP White Beeswax 4 Drop pointBP White Beeswax 5 Acid ValueBP White Beeswax 6 Ester ValueBP White Beeswax 7 Saponification ValueBP White Beeswax 8BP White Beeswax 9 Glycerol and other polyolsBP White Soft Paraffin 1 AppearanceBP White Soft Paraffin 2 SolubilityBP White Soft Paraffin 3 Identification ABP White Soft Paraffin 4 Identification BBP White Soft Paraffin 5 Identification CBP White Soft Paraffin 6 Identification DBP White Soft Paraffin 7 Appearance (Test)BP White Soft Paraffin 8 Acidity or alkalinityBP White Soft Paraffin 9 ConsistencyBP White Soft Paraffin 10 Polycyclic aromatic hydrocarbonsBP White Soft Paraffin 11 Sulfated AshBP Wool Alcohols 1 AppearanceBP Wool Alcohols 2 SolubilityBP Wool Alcohols 3 IdentificationBP Wool Alcohols 4 Appearance of solutionBP Wool Alcohols 5 AlkalinityBP Wool Alcohols 6 Melting pointBP Wool Alcohols 7 Water absorption capacityBP Wool Alcohols 8 Acid ValueBP Wool Alcohols 9 Hydroxyl ValueBP Wool Alcohols 10 Peroxide ValueBP Wool Alcohols 11 Saponification ValueBP Wool Alcohols 12 Loss on DryingBP Wool Alcohols 13 Total AshBP Wool Alcohols 14 AssayBP Wool Fat 1 AppearanceBP Wool Fat 2 SolubilityBP Wool Fat 3 Identification ABP Wool Fat 4 Identification BBP Wool Fat 5 Water-soluble acid or alkaline substancesBP Wool Fat 6 Water-sbsorption capacityBP Wool Fat 7 Acid ValueBP Wool Fat 8 Peroxide ValueBP Wool Fat 9 Saponification ValueBP Wool Fat 10 Water-soluble oxidisable substances

Ceresin, paraffins and certain other waxes

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 124 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Wool Fat 11 Chlorides

BP Wool Fat 12 Loss on dryingBP Wool Fat 13 Sulfated AshBP Wool Fat 14 Drop pointBP Xanthan Gum 1 AppearanceBP Xanthan Gum 2 SolubilityBP Xanthan Gum 3 Identification ABP Xanthan Gum 4 Identification BBP Xanthan Gum 5 pHBP Xanthan Gum 7 Other PolysaccharidesBP Xanthan Gum 8 Loss on dryingBP Xanthan Gum 9 Total AshBP Xanthan Gum 10 AssayBP Xanthan Gum (2-Propanol) 6 2-PropanolBP Xylitol 1 AppearanceBP Xylitol 2 SolubilityBP Xylitol 3 Identification ABP Xylitol 4 Identification BBP Xylitol 5 Identification CBP Xylitol 6 Appearance of solutionBP Xylitol 7 ConductivityBP Xylitol 8 Reducing SugarsBP Xylitol Water

9 Related Substances

10 Assay (anhydrous substance)

10 Assay (as is basis)BP Yarrow 1 Identification CBP Yarrow 2 Identification DBP Yarrow 3 Foreign MatterBP Yarrow 4 Loss on DryingBP Yarrow 5 Total AshBP Yarrow 6 Ash insoluble in hydrochloric acidBP Yarrow 7 Assay (Essential Oil)BP Yarrow 8 Assay (Proazulenes)BP Yellow Beeswax 1 AppearanceBP Yellow Beeswax 2 SolubilityBP Yellow Beeswax 3 Relative densityBP Yellow Beeswax 4 Drop pointBP Yellow Beeswax 5 Acid ValueBP Yellow Beeswax 6 Ester ValueBP Yellow Beeswax 7 Saponification ValueBP Yellow Beeswax 8BP Yellow Beeswax 9 Glycerol and other polyolsBP Yellow Soft Paraffin 1 CharactersBP Yellow Soft Paraffin 2 Identification ABP Yellow Soft Paraffin 3 Identification BBP Yellow Soft Paraffin 4 Identification CBP Yellow Soft Paraffin 5 Identification DBP Yellow Soft Paraffin 6 Appearance

BP Xylitol (Assay and/or Related substances)BP Xylitol (Assay and/or Related substances)BP Xylitol (Assay and/or Related substances)

Ceresin, paraffins and certain other waxes

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 125 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberBP Yellow Soft Paraffin 7 Acidity or alkalinity

BP Yellow Soft Paraffin 8 ConsistencyBP Yellow Soft Paraffin 9 Polycyclic aromatic hydrocarbonsBP Yellow Soft Paraffin 10 Sulfated AshBP Zinc Gluconate 1 AppearanceBP Zinc Gluconate 2 SolubilityBP Zinc Gluconate 3 Identification ABP Zinc Gluconate 4 Identification BBP Zinc Gluconate 5 Appearance of solutionBP Zinc Gluconate 6 Sucrose and reducing sugarsBP Zinc Gluconate 7 ChloridesBP Zinc Gluconate 8 SulfatesBP Zinc Gluconate 9 Heavy MetalsBP Zinc Gluconate 10 WaterBP Zinc Gluconate 11 AssayBP Zinc Oxide 1 AppearanceBP Zinc Oxide 2 SolubilityBP Zinc Oxide 3 Identification ABP Zinc Oxide 4 Identification BBP Zinc Oxide 5 AlkalinityBP Zinc Oxide 6BP Zinc Oxide 7 IronBP Zinc Oxide 8 Loss on ignitionBP Zinc Oxide 9 AssayBP Zinc Sulfate Monohydrate 1 AppearanceBP Zinc Sulfate Monohydrate 2 SolubilityBP Zinc Sulfate Monohydrate 3 Identification ABP Zinc Sulfate Monohydrate 4 Identification BBP Zinc Sulfate Monohydrate 5 Identification CBP Zinc Sulfate Monohydrate 6 Appearance of solutionBP Zinc Sulfate Monohydrate 7 pHBP Zinc Sulfate Monohydrate 8 ChloridesBP Zinc Sulfate Monohydrate 9 IronBP Zinc Sulfate Monohydrate 10 AssayBP Zinc Undecenoate 1 AppearanceBP Zinc Undecenoate 2 SolubilityBP Zinc Undecenoate 3 Melting pointBP Zinc Undecenoate 4 Identification ABP Zinc Undecenoate 5 Identification BBP Zinc Undecenoate 6 Identification CBP Zinc Undecenoate 7 AlkalinityBP Zinc Undecenoate 8 Alkali and alkaline-earth metalsBP Zinc Undecenoate 9 SulfatesBP Zinc Undecenoate 10 Loss on DryingBP Zinc Undecenoate 11 Degree of unsaturationBP Zinc Undecenoate 12 AssayBP(-)-a- Bisabolol 1 AssayFCC Calcium Hydroxide 1 DescriptionFCC Calcium Hydroxide 2 AlkalinityFCC Calcium Hydroxide 3 CalciumFCC Calcium Hydroxide 4 Assay

Carbonates and substances insoluble in acids

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 126 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberFCC Calcium Hydroxide 5 Carbonate

FCC Calcium Hydroxide 6 FluorideFCC Calcium Hydroxide 7 Magnesium and alkali saltsFCC Calcium Hydroxide 8 Acid-insoluble substancesFCC Cellulose Gum 1 DescriptionFCC Cellulose Gum 2 Identification AFCC Cellulose Gum 3 Identification BFCC Cellulose Gum 4 Sodium ChlorideFCC Cellulose Gum 4 Sodium glycolateFCC Cellulose Gum 4 AssayFCC Cellulose Gum 5 Degree of SubstitutionFCC Cellulose Gum 6 Loss on DryingFCC Cellulose Gum 7 SodiumFCC Cellulose Gum 8 ViscosityFCC Citric Acid 1 DescriptionFCC Citric Acid 2 Identification (Citrate)FCC Citric Acid 3 AssayFCC Citric Acid 4 OxalateFCC Citric Acid 5 Readily carbonizable substancesFCC Citric Acid 6 Residue on IgnitionFCC Citric Acid 7 WaterFCC Dextrose 1 Specific Optical RotationFCC Fluoride Limit Test Fluorides - Method IIIFCC Inulin 2 Total AshFCC Inulin 3 Loss on DryingFCC Inulin 4 Monosaccharides and DisaccharidesFCC Inulin 5 Optical (Specific) RotationFCC Inulin 1 AssayFCC Potassium Sorbate 1 DescriptionFCC Potassium Sorbate 2 Identification AFCC Potassium Sorbate 3 Identification BFCC Potassium Sorbate 4 AssayFCC Potassium Sorbate 5 Acidity (as Sorbic Acid)FCC Potassium Sorbate 6 Alkalinity (as K2CO3)FCC Potassium Sorbate 7 Loss on DryingFCC Sodium Acetate Anhydrous 1 DescriptionFCC Sodium Acetate Anhydrous 2 Identification - AcetateFCC Sodium Acetate Anhydrous 3 Identification - SodiumFCC Sodium Acetate Anhydrous 4 AssayFCC Sodium Acetate Anhydrous 5 Loss on dryingFCC Sodium Acetate Anhydrous 6 AlkalinityFCC Sodium Acetate Anhydrous 7 Potassium CompoundsFCC Sodium Benzoate 1 Identification - BenzoateFCC Sodium Benzoate 2 Identification - SodiumFCC Sodium Benzoate 3 AssayFCC Sodium Benzoate 4 AlkalinityFCC Sodium Benzoate 5 WaterFCC Sodium Bicarbonate 1 DescriptionFCC Sodium Bicarbonate 2 Identification - SodiumFCC Sodium Bicarbonate 3 AssayFCC Sodium Bicarbonate 4 Loss on dryingFCC Sodium Bicarbonate 5 Insoluble Substances

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 127 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberFCC Sodium Citrate 1 Description

FCC Sodium Citrate 2 Identification (Citrate)FCC Sodium Citrate 3 Identification (Sodium Flame)FCC Sodium Citrate 3 Identification (Sodium)FCC Sodium Citrate 4 AssayFCC Sodium Citrate 5 AlkalinityFCC Sodium Citrate 6 WaterFCC Sodium Hypophosphite 1 DescriptionFCC Sodium Hypophosphite 2 Identification - HypophosphitesFCC Sodium Hypophosphite 3 Identification - SodiumFCC Sodium Hypophosphite 4 AssayFCC Sodium Hypophosphite 5 FluorideFCC Sodium Hypophosphite 6 Insoluble SubstancesFCC Sodium Polyphosphates, Glassy 1 DescriptionFCC Sodium Polyphosphates, Glassy 2 Identification AFCC Sodium Polyphosphates, Glassy 3 Identification BFCC Sodium Polyphosphates, Glassy 4 AssayFCC Sodium Polyphosphates, Glassy 5 FluorideFCC Sodium Polyphosphates, Glassy 6 Insoluble SubstancesFCC Sodium Propionate 1 DescriptionFCC Sodium Propionate 2 Identification AFCC Sodium Propionate 3 Identification BFCC Sodium Propionate 4 Identification CFCC Sodium Propionate 5 AssayFCC Sodium Propionate 6 IronFCC Sodium Propionate 7 Alkalinity (as Na2CO3)FCC Sodium Propionate 8 WaterFCC Sodium Pyrophosphate 1 DescriptionFCC Sodium Pyrophosphate 2 Identification AFCC Sodium Pyrophosphate 3 Identification BFCC Sodium Pyrophosphate 4 AssayFCC Sodium Pyrophosphate 5 FluorideFCC Sodium Pyrophosphate 6 Insoluble substancesFCC Sodium Pyrophosphate 7 Loss on ignitionFCC Sodium Tripolyphosphate 1 Identification AFCC Sodium Tripolyphosphate 2 Identification BFCC Sodium Tripolyphosphate 3 AssayFCC Sodium Tripolyphosphate 4 FluorideFCC Sodium Tripolyphosphate 5 Insoluble SubstancesFCC Sulfuric Acid 1 DescriptionFCC Sulfuric Acid 2 Identification - SulfateFCC Sulfuric Acid 3 AssayFCC Sulfuric Acid 4 ChlorideFCC Sulfuric Acid 5 IronFCC Sulfuric Acid 6 NitrateFCC Sulfuric Acid 7 Reducing Substances (as SO2)FCC Sulfuric Acid 8 SeleniumFCC Sulphur Dioxide 1 Sulphur dioxideFCC Tartaric Acid 1 DescriptionFCC Tartaric Acid 2 Identification (Tartrate)FCC Tartaric Acid 3 AssayFCC Tartaric Acid 4 Sulfate

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 128 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberFCC Tartaric Acid 5 Loss on Drying

FCC Tartaric Acid 5 OxalateFCC Tartaric Acid 6 Optical (Specific) RotationFCC Tartaric Acid 7 Residue on IgnitionFCC Total Color 1 Total Dye Content

1 Urea Content

2 Alkalinity

3 Biuret content

4 Aldehyde content

5 Insoluble matter content

6 Phosphate content

7 Identity by FTIRJP Benfotiamine 1 Identification 1JP Benfotiamine 2 Loss on DryingJP Benfotiamine 3 AssayJP Water Determination (KF method) 1 WaterUSP Acetone 1 Identification AUSP Acetone 4 Specific GravityUSP Acetone 5 Readily oxidizable substancesUSP Acetone (ID B and/or Assay) 2 Identification BUSP Acetone (ID B and/or Assay) 3 AssayUSP Alcohol 1 Identification A (SG)USP Alcohol 2 Identification B (FTIR)USP Alcohol 3 Limit of nonvolatile residueUSP Alcohol 5 Specific GravityUSP Alcohol 6 UV AbsorptionUSP Alcohol 7 Clarity of solutionUSP Alcohol 8 Acidity or AlkalinityUSP Alcohol 9 Colour of solutionUSP Alcohol (Organic impurities) 4 Organic ImpuritiesUSP Alcohol (Organic impurities) 4 MethanolUSP Alcohol (Organic impurities) 4 Sum of all other impuritiesUSP Alcohol (Organic impurities) 4 BenzeneUSP Alcohol (Organic impurities) 4 Acetaldehyde and acetalUSP Alkyl (C12-15) Benzoate 1 IdentificationUSP Alkyl (C12-15) Benzoate 2 Residue on IgnitionUSP Alkyl (C12-15) Benzoate 3 WaterUSP Alkyl (C12-15) Benzoate 4 Specific GravityUSP Alkyl (C12-15) Benzoate 5 Acid ValueUSP Alkyl (C12-15) Benzoate 6 Refractive indexUSP Alkyl (C12-15) Benzoate 7 Saponification ValueUSP Alkyl (C12-15) Benzoate 8USP Allyl Isothiocyanate 1 Identification by Infrared AbsorptionUSP Allyl Isothiocyanate 2 AssayUSP Allyl Isothiocyanate 3 Limit of phenols

ISO Diesel engines - NOx reduction agent AUS 32ISO Diesel engines - NOx reduction agent AUS 32ISO Diesel engines - NOx reduction agent AUS 32ISO Diesel engines - NOx reduction agent AUS 32ISO Diesel engines - NOx reduction agent AUS 32ISO Diesel engines - NOx reduction agent AUS 32ISO Diesel engines - NOx reduction agent AUS 32

Viscosity (Rotational Rhemometer Method)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 129 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Allyl Isothiocyanate 4 Specific Gravity

USP Allyl Isothiocyanate 5 Refractive indexUSP Allyl Isothiocyanate 6 Distilling Range, Method 1USP Alpha Lipoic Acid 2 Identification BUSP Alpha Lipoic Acid 4 Residue on IgnitionUSP Alpha Lipoic Acid 5 Heavy MetalsUSP Alpha Lipoic Acid 7 Chromatographic Purity -Test 2USP Alpha Lipoic Acid 8 Melting temperatureUSP Alpha Lipoic Acid 9 Specific Optical RotationUSP Alpha Lipoic Acid 10 Loss on Drying

1 Identification A

3 Assay

6 Chromatographic Purity -Test 1

6 Individual Impurities

6 Total impuritiesUSP Amiloride Hydrochloride 1 Identification AUSP Amiloride Hydrochloride 2 Identification BUSP Amiloride Hydrochloride 3 Identification CUSP Amiloride Hydrochloride 4 AssayUSP Amiloride Hydrochloride 5 Residue on IgnitionUSP Amiloride Hydrochloride 6 Heavy Metals (Method II)USP Amiloride Hydrochloride 7 Organic ImpuritiesUSP Amiloride Hydrochloride 8 AcidityUSP Amiloride Hydrochloride 9 Loss on DryingUSP Anhydrous Dibasic Calcium Phosphate 1 Identification AUSP Anhydrous Dibasic Calcium Phosphate 2 Identification BUSP Anhydrous Dibasic Calcium Phosphate 3 AssayUSP Anhydrous Dibasic Calcium Phosphate 4 CarbonateUSP Anhydrous Dibasic Calcium Phosphate 5 ChlorideUSP Anhydrous Dibasic Calcium Phosphate 6 SulfateUSP Anhydrous Dibasic Calcium Phosphate 7 BariumUSP Anhydrous Dibasic Calcium Phosphate 8 Heavy MetalsUSP Anhydrous Dibasic Calcium Phosphate 9 Limit of acid - insoluble substancesUSP Anhydrous Dibasic Calcium Phosphate 10 Limit of fluorideUSP Anhydrous Dibasic Calcium Phosphate 11 Loss on ignitionUSP Anydrous Citric Acid 1 Identification AUSP Anydrous Citric Acid 2 AssayUSP Anydrous Citric Acid 3 Residue on IgnitionUSP Anydrous Citric Acid 4 Heavy MetalsUSP Anydrous Citric Acid 5 SulfateUSP Anydrous Citric Acid 6 Limit of AluminumUSP Anydrous Citric Acid 7 Limit of oxalic acidUSP Anydrous Citric Acid 8 Clarity of solutionUSP Anydrous Citric Acid 9 Color of solutionUSP Anydrous Citric Acid 10 Readily carbonizable substancesUSP Anydrous Citric Acid 11 WaterUSP Articles of Botanical Origin <561> WaterUSP Articles of Botanical Origin <561> Total Ash

USP Alpha Lipoic Acid (ID A and/or Assay and/or Chromatographic purity)USP Alpha Lipoic Acid (ID A and/or Assay and/or Chromatographic purity)USP Alpha Lipoic Acid (ID A and/or Assay and/or Chromatographic purity)USP Alpha Lipoic Acid (ID A and/or Assay and/or Chromatographic purity)USP Alpha Lipoic Acid (ID A and/or Assay and/or Chromatographic purity)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 130 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Articles of Botanical Origin <561> Acid-insoluble ash

USP Ascorbic Acid 1 Identification AUSP Ascorbic Acid 2 Identification BUSP Ascorbic Acid 3 AssayUSP Ascorbic Acid 4 Residue on IgnitionUSP Ascorbic Acid 5 Heavy MetalsUSP Ascorbic Acid 6 Optical (Specific) RotationUSP Avobenzone 1 Identification AUSP Avobenzone 2 Identification BUSP Avobenzone 5 Loss on Drying

3 Assay (as is basis)

3 Assay (anhydrous basis)

4 Organic Impurities

4 Individual Impurity

4 Total ImpuritiesUSP Bemotrizinol 1 Identification AUSP Bemotrizinol 2 Identification BUSP Bemotrizinol 3 AssayUSP Bemotrizinol 4 Heavy MetalsUSP Benzethonium Chloride 1 Identification AUSP Benzethonium Chloride 2 Identification BUSP Benzethonium Chloride 3 AssayUSP Benzethonium Chloride 4 Residue on IgnitionUSP Benzethonium Chloride 5 Melting rangeUSP Benzethonium Chloride 6 Loss on DryingUSP Biotin 1 Identification AUSP Biotin 2 Identification BUSP Biotin 6 Specific Optical Rotation

3 Identification C

4 Assay

5 Related compounds

5 Individual impurity

5 Total impuritiesUSP Bisoctrizole 1 Identification AUSP Bisoctrizole 2 Identification BUSP Bisoctrizole 3 AssayUSP Bisoctrizole 4 Heavy MetalsUSP Bisoctrizole 5 Related compoundsUSP Bisoctrizole 5 Bisoctrizole related compound AUSP Bisoctrizole 6 Bisoctrizole isomerUSP Bisoctrizole 7 Organic ImpuritiesUSP Bisoctrizole 7 Any Idividual unspecified impurityUSP Bisoctrizole 7 Total impurities

USP Avobenzone (Assay and/or Chromatographic purity)USP Avobenzone (Assay and/or Chromatographic purity)USP Avobenzone (Assay and/or Chromatographic purity)USP Avobenzone (Assay and/or Chromatographic purity)USP Avobenzone (Assay and/or Chromatographic purity)

USP Biotin (ID C and/or Assay and/or Related compounds)USP Biotin (ID C and/or Assay and/or Related compounds)USP Biotin (ID C and/or Assay and/or Related compounds)USP Biotin (ID C and/or Assay and/or Related compounds)USP Biotin (ID C and/or Assay and/or Related compounds)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 131 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Boswellia serrata Extract 1 Identification A

USP Boswellia serrata Extract 2 Identification BUSP Boswellia serrata Extract 3 Loss on dryingUSP Butylated Hydroxytoluene 1 Identification AUSP Butylated Hydroxytoluene 2 Residue on IgnitionUSP Butylated Hydroxytoluene 3 Heavy MetalsUSP Butylated Hydroxytoluene 4 Organic ImpuritiesUSP Butylated Hydroxytoluene 5 Congealing temperatureUSP Calcium Ascorbate 2 Identification BUSP Calcium Ascorbate 3 Identification CUSP Calcium Ascorbate 4 Assay (as is basis)USP Calcium Ascorbate 6 Heavy MetalsUSP Calcium Ascorbate 7 Limit of fluorideUSP Calcium Ascorbate 8 Optical (Specific) RotationUSP Calcium Ascorbate 9 pHUSP Calcium Ascorbate 10 Loss on DryingUSP Calcium Citrate 1 Identification AUSP Calcium Citrate 2 Identification BUSP Calcium Citrate 3 AssayUSP Calcium Citrate 4 Heavy MetalsUSP Calcium Citrate 5 Limit of fluorideUSP Calcium Citrate 6 Limit of acid - insoluble substancesUSP Calcium Citrate 7 Loss on DryingUSP Calcium Pantothenate 1 Identification AUSP Calcium Pantothenate 2 Identification BUSP Calcium Pantothenate 3 Assay (Nitrogen Determination Method I)USP Calcium Pantothenate 4 Assay (Contentof Calcium)USP Calcium Pantothenate 5 Heavy MetalsUSP Calcium Pantothenate 6 Ordinary ImpuritiesUSP Calcium Pantothenate 7 Optical (Specific) RotationUSP Calcium Pantothenate 8 AlkalinityUSP Calcium Pantothenate 9 Loss on DryingUSP Carbamide Peroxide Topical Solution 1 Identification AUSP Carbamide Peroxide Topical Solution 2 Identification BUSP Carbamide Peroxide Topical Solution 3 Specific GravityUSP Carbamide Peroxide Topical Solution 4 pHUSP Carbomer 934 1 ViscosityUSP Carbomer 934P 1 Identification AUSP Carbomer 934P 2 Identification BUSP Carbomer 934P 3 Assay (Carboxylic acid content)USP Carbomer 934P 4 Heavy MetalsUSP Carbomer 934P 6 Loss on DryingUSP Carbomer 934P 7 ViscosityUSP Carbomer 934P (Limit of Benzene) 5 Limit of BenzeneUSP Carbomer 940 2 ViscosityUSP Carbomer 940 (Limit of Benzene) 1 Limit of BenzeneUSP Carbomer Homopolymer 1 Identification AUSP Carbomer Homopolymer 2 Identification BUSP Carbomer Homopolymer 3 Assay (Carboxylic acid content)USP Carbomer Homopolymer 4 Heavy MetalsUSP Carbomer Homopolymer 5 Limit of cyclohexaneUSP Carbomer Homopolymer 5 Limit of ethyl acetate

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 132 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Carbomer Homopolymer 6 Limit of Benzene

USP Carbomer Homopolymer 7 Limit of acrylic acidUSP Carbomer Homopolymer 8 Loss on DryingUSP Carboxymethylcellulose Sodium 1 Identification AUSP Carboxymethylcellulose Sodium 2 Identification BUSP Carboxymethylcellulose Sodium 3 Identification CUSP Carboxymethylcellulose Sodium 4 AssayUSP Carboxymethylcellulose Sodium 6 Heavy metalsUSP Carboxymethylcellulose Sodium 7USP Carboxymethylcellulose Sodium 8 Loss on DryingUSP Castor Oil 1 Heavy MetalsUSP Castor Oil 2 Specific GravityUSP Castor Oil 3 Free fatty acidUSP Castor Oil 4 Hydroxyl ValueUSP Castor Oil 5 Iodine ValueUSP Castor Oil 6 Saponification ValueUSP Chitosan 1 Identification AUSP Chitosan 2 Identification BUSP Chitosan 3 Residue on IgnitionUSP Chitosan 4 Heavy MetalsUSP Chitosan 5 Metals Limit Tests (3 or more elements)USP Chitosan 5 LeadUSP Chitosan 6 MercuryUSP Chitosan 7 ChromiumUSP Chitosan 8 NickelUSP Chitosan 9 CadmiumUSP Chitosan 10 ArsenicUSP Chitosan 11 IronUSP Chitosan 12 Loss on DryingUSP Chlorophyllin Copper Complex Sodium 1 Identification AUSP Chlorophyllin Copper Complex Sodium 2 Nitrogen Determination Method IUSP Chlorophyllin Copper Complex Sodium 3 Residue on IgnitionUSP Chlorophyllin Copper Complex Sodium 4 IronUSP Chlorophyllin Copper Complex Sodium 5 pHUSP Chlorophyllin Copper Complex Sodium 6 Loss on DryingUSP Chlorophyllin Copper Complex Sodium 7 Test for FluorescenceUSP Chlorothiazide 1 Identification AUSP Chlorothiazide 2 Identification BUSP Chlorothiazide 3 Loss on DryingUSP Chlorothiazide 4 Residue on IgnitionUSP Chlorothiazide 5 ChlorideUSP Chlorothiazide 6 SeleniumUSP Chlorothiazide 7 Heavy MetalsUSP Chlorothiazide 8 Related CompoundsUSP Chlorothiazide 9 AssayUSP Chloroxylenol 2 Identification BUSP Chloroxylenol 3 AssayUSP Chloroxylenol 4 Residue on IgnitionUSP Chloroxylenol 5 IronUSP Chloroxylenol 6 Organic ImpuritiesUSP Chloroxylenol 7 Melting range

Viscosity (Rotational Rhemometer Method)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 133 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Chloroxylenol 8 Water

USP Cholesterol 1 Identification AUSP Cholesterol 2 Identification BUSP Cholesterol 3 Residue on IgnitionUSP Cholesterol 4 Melting rangeUSP Cholesterol 5 Optical (Specific) RotationUSP Cholesterol 6 AcidityUSP Cholesterol 7 Loss on DryingUSP Cholesterol 8 solubility in AlcoholUSP Choline Bitartrate 1 Identification AUSP Choline Bitartrate 2 Identification BUSP Choline Bitartrate 3 AssayUSP Choline Bitartrate 5 Residue on IgnitionUSP Choline Bitartrate 6 Heavy MetalsUSP Choline Bitartrate 7 Limit of total aminesUSP Choline Bitartrate 9 Specific Optial RotationUSP Choline Bitartrate 10 pHUSP Choline Bitartrate 11 Water

8 Chromatographic purity

8 Total impurities

8 Individual ImpuritiesUSP Choline Bitartrate (Residual solvents) 4 Residual solventsUSP Chondroitin Sulfate Sodium 1 Identification AUSP Chondroitin Sulfate Sodium 2 Identification BUSP Chondroitin Sulfate Sodium 3 Residue on IgnitionUSP Chondroitin Sulfate Sodium 4 ChlorideUSP Chondroitin Sulfate Sodium 5 SulfateUSP Chondroitin Sulfate Sodium 6 Limit of proteinUSP Chondroitin Sulfate Sodium 7 Heavy MetalsUSP Chondroitin Sulfate Sodium 8 Clarity and color of solutionUSP Chondroitin Sulfate Sodium 9 Optical (Specific) RotationUSP Chondroitin Sulfate Sodium 10 pHUSP Chondroitin Sulfate Sodium 11 Loss on dryingUSP Chromic Chloride 1 Identification AUSP Chromic Chloride 2 Identification BUSP Chromic Chloride 3 AssayUSP Chromic Chloride 4 SulfateUSP Chromic Chloride 5 IronUSP Chromic Chloride 6 Insoluble MatterUSP Chromic Chloride 7USP Chromium Picolinate 1 Identification AUSP Chromium Picolinate 2 Identification BUSP Chromium Picolinate 3 ChlorideUSP Chromium Picolinate 4 SulfateUSP Chromium Picolinate 5 Loss on DryingUSP Cocoa Butter 2 Refractive indexUSP Cocoa Butter 3 Free fatty acidUSP Cocoa Butter 4 Iodine ValueUSP Cocoa Butter 5 Saponification Value

USP Choline Bitartrate (Chromatographic purity)USP Choline Bitartrate (Chromatographic purity)USP Choline Bitartrate (Chromatographic purity)

Substances not precipitated by ammonium hydroxide

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 134 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Cocoa Butter (Fatty acid composition) 1 Fatty Acid Composition

USP Cocoa Butter (Fatty acid composition) 1 Stearic acidUSP Cocoa Butter (Fatty acid composition) 1 Linoleic acidUSP Cocoa Butter (Fatty acid composition) 1 Arachidic acidUSP Cocoa Butter (Fatty acid composition) 1 Palmitic acidUSP Cocoa Butter (Fatty acid composition) 1 Oleic acidUSP Cocoa Butter (Fatty acid composition) 1 Linolenic acidUSP Cocoa Butter (Fatty acid composition) 1 C14:0 (Myristic Acid)USP Coconut Oil 1 Identification AUSP Coconut Oil 2 Alkaline ImpuritiesUSP Coconut Oil 3 Acid ValueUSP Coconut Oil 4 Fatty Acid CompositionUSP Coconut Oil 4 C18:1 (cis-Oleic Acid )USP Coconut Oil 4 C18:3 (Linolenic Acid)USP Coconut Oil 4 C20:1 (Eicosenoic Acid)USP Coconut Oil 4 C8:0 (Caprylic Acid)USP Coconut Oil 4 C12.0 (Lauric Acid)USP Coconut Oil 4 C16:0 (Palmitic Acid )USP Coconut Oil 4 C18:0 (Stearic Acid )USP Coconut Oil 4 C18:2 (Linoleic Acid)USP Coconut Oil 4 C20:0 (Arachidic Acid)USP Coconut Oil 4 C6:0 (Caproic Acid)USP Coconut Oil 4 C10: 0 (Capric Acid)USP Coconut Oil 4 C16.1 (Palmitoleic Acid)USP Coconut Oil 5 Peroxide ValueUSP Coconut Oil 6 Unsaponifiable matterUSP Coconut Oil 7 Melting rangeUSP Coconut Oil 8 Water DeterminationUSP Colloidal Oatmeal 1 Identification AUSP Colloidal Oatmeal 2 Identification BUSP Colloidal Oatmeal 3 Total AshUSP Colloidal Oatmeal 4 Nitrogen Determination Method IUSP Colloidal Oatmeal 5 Loss on dryingUSP Colloidal Oatmeal 6 Particle SizeUSP Colloidal Oatmeal 7 Fat contentUSP Colloidal Oatmeal 8 Viscosity (Rotational)USP Colloidal Silicon Dioxide 1 Identification AUSP Colloidal Silicon Dioxide 2 Identification BUSP Colloidal Silicon Dioxide 3 Assay (Ignited basis)USP Colloidal Silicon Dioxide 4 Loss on ignitionUSP Colloidal Silicon Dioxide 5 pHUSP Colloidal Silicon Dioxide 6 Loss on DryingUSP Congealing Temperature 1 Congealing TemperatureUSP Containers - Plastics <661> 1 Nonvolatile ResidueUSP Containers - Plastics <661> 2 Residue on IgnitionUSP Containers - Plastics <661> 3 Heavy MetalsUSP Containers - Plastics <661> 4 Buffering CapacityUSP Copper Gluconate 1 Identification AUSP Copper Gluconate 2 Identification BUSP Copper Gluconate 3 AssayUSP Copper Gluconate 4 ChlorideUSP Copper Gluconate 5 Sulfate

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 135 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Copper Gluconate 6 Reducing Substances

USP Cupric Sulfate 1 Identification AUSP Cupric Sulfate 2 Identification BUSP Cupric Sulfate 3 AssayUSP Cupric Sulfate 4 Loss on DryingUSP Curcuminoids 1 Identification AUSP Curcuminoids 2 Identification BUSP Curcuminoids 3 Content of CurcuminoidsUSP Curcuminoids 3 CurcuminUSP Curcuminoids 3 DesmethoxycurcuminUSP Curcuminoids 3 BisdesmethoxycurcuminUSP Curcuminoids 3 Total CurcuminoidsUSP Curcuminoids 4 Heavy MetalsUSP Curcuminoids 5 Melting rangeUSP Curcuminoids 6 Loss on DryingUSP Curcuminoids 7 Total AshUSP Curcuminoids Capsules 1 Identification AUSP Curcuminoids Capsules 2 Identification BUSP Curcuminoids Capsules 3 StrengthUSP Curcuminoids Capsules 3 CurcuminUSP Curcuminoids Capsules 3 BisdesmethoxycurcuminUSP Curcuminoids Capsules 3 DesmethoxycurcuminUSP Cyanocobalamin 1 Identification AUSP Cyanocobalamin 2 Identification BUSP Cyanocobalamin 4 AssayUSP Cyanocobalamin 6 Loss on Drying

3 Identification C

5 Related compounds

5 50-Carboxycyanocobalamin

5 34-Methylcyanocobalamin

5 Total impurities

5 8-Epi-cyanocobalamin

5 Any other unidentified impurity

5 7ß, 8ß - Lactocyanocobalamin

5 32-CarboxycyanocobalaminUSP Cyclomethicone 1 IdentificationUSP Cyclomethicone 2 AssayUSP Cyclomethicone 2 Cyclomethicone D5USP Cyclomethicone 2 Cyclomethicone D4USP Cyclomethicone 2 Cyclomethicone D6USP Cyclomethicone 3 Limit of nonvolatile residueUSP Dental - Type Silica 1 Assay (Silicon Dioxide)USP Dental - Type Silica 2 Assay (Sodium Sulfate)USP Dental - Type Silica 3 pH

USP Cyanocobalamin (ID C and/or Related compounds)USP Cyanocobalamin (ID C and/or Related compounds)USP Cyanocobalamin (ID C and/or Related compounds)USP Cyanocobalamin (ID C and/or Related compounds)USP Cyanocobalamin (ID C and/or Related compounds)USP Cyanocobalamin (ID C and/or Related compounds)USP Cyanocobalamin (ID C and/or Related compounds)USP Cyanocobalamin (ID C and/or Related compounds)USP Cyanocobalamin (ID C and/or Related compounds)

Page 136: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 136 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Dental - Type Silica 4 Loss on Drying

USP Dental - Type Silica 5 Loss on IgnitionUSP Dental - Type Silica 6 ChlorideUSP Dental - Type Silica 7 Heavy MatalsUSP Determination of Nitrogen method II 1 ProteinUSP Determination of Nitrogen method II 1 Creatine MonohydrateUSP Determination of Nitrogen method II 1 NitrogenUSP Determination of pH 1 pHUSP Dexpanthenol 1 Identification AUSP Dexpanthenol 2 Identification BUSP Dexpanthenol 3 Identification CUSP Dexpanthenol 4 AssayUSP Dexpanthenol 5 Residue on IgnitionUSP Dexpanthenol 6 Limit of aminopropanolUSP Dexpanthenol 7 Specific Optical RotationUSP Dexpanthenol 8 Refractive indexUSP Dexpanthenol 9 Water DeterminationUSP Dextroamphetamine Sulfate 1 Identification AUSP Dextroamphetamine Sulfate 2 Identification BUSP Dextroamphetamine Sulfate 3 AssayUSP Dextroamphetamine Sulfate 4 Residue on IgnitionUSP Dextroamphetamine Sulfate 5 Organic ImpuritiesUSP Dextroamphetamine Sulfate 6 Specific Optical RotationUSP Dextroamphetamine Sulfate 7 pHUSP Dextroamphetamine Sulfate 8 Loss on DryingUSP Dextromethorphan Hydrobromide 1 Identification AUSP Dextromethorphan Hydrobromide 2 Identification BUSP Dextromethorphan Hydrobromide 3 Identification CUSP Dextromethorphan Hydrobromide 4 Specific RotationUSP Dextromethorphan Hydrobromide 5 pHUSP Dextromethorphan Hydrobromide 6 WaterUSP Dextromethorphan Hydrobromide 7 Residue on IgnitionUSP Dextromethorphan Hydrobromide 8 Limit of N,N-dimethylanineUSP Dextromethorphan Hydrobromide 9 Limit of Phenolic compoundsUSP Dextromethorphan Hydrobromide 10 AssayUSP Dextrose 1 Identification AUSP Dextrose 2 Residue on IgnitionUSP Dextrose 3 ChlorideUSP Dextrose 4 SulfateUSP Dextrose 5 Heavy MetalsUSP Dextrose 6 Color of solutionUSP Dextrose 7 AcidityUSP Dextrose 8 Water DeterminationUSP Dextrose 9 Specific Optical RotationUSP Dextrose 10 DextrinUSP Dextrose 11 Soluble Starch, SulfitesUSP Diatrizoic Acid 1 Identification AUSP Diatrizoic Acid 2 Identification BUSP Diatrizoic Acid 3 Assay (anhydrous basis)USP Diatrizoic Acid 4 Residue on IgnitionUSP Diatrizoic Acid 5 Heavy MetalsUSP Diatrizoic Acid 6 Free Aromatic Amine

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 137 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Diatrizoic Acid 7 Water

USP Diatrizoic Acid 8 Iodine and IodideUSP Dibasic Potassium Phosphate 1 Identification AUSP Dibasic Potassium Phosphate 2 Identification BUSP Dibasic Potassium Phosphate 3 AssayUSP Dibasic Potassium Phosphate 4 Insoluble SubstancesUSP Dibasic Potassium Phosphate 5 CarbonateUSP Dibasic Potassium Phosphate 6 ChlorideUSP Dibasic Potassium Phosphate 7 SulfateUSP Dibasic Potassium Phosphate 8 IronUSP Dibasic Potassium Phosphate 9 SodiumUSP Dibasic Potassium Phosphate 10 Limit of fluorideUSP Dibasic Potassium Phosphate 11 Limit of Mono or Tribasic SaltUSP Dibasic Potassium Phosphate 12 pHUSP Dibasic Potassium Phosphate 13 Loss on DryingUSP Dibasic Sodium Phosphate 2 Identification BUSP Dibasic Sodium Phosphate 3 AssayUSP Dibasic Sodium Phosphate 4 Insoluble SubstancesUSP Dibasic Sodium Phosphate 5 ChlorideUSP Dibasic Sodium Phosphate 6 SulfateUSP Dibasic Sodium Phosphate 7 ArsenicUSP Dibasic Sodium Phosphate 8 Heavy MetalsUSP Dibasic Sodium Phosphate 9 Loss on DryingUSP Diloxanide Furoate 1 Identification AUSP Diloxanide Furoate 2 Identification BUSP Diloxanide Furoate 3 Identification CUSP Diloxanide Furoate 4 AssayUSP Diloxanide Furoate 5 Residue on IgnitionUSP Diloxanide Furoate 6 Organic ImpuritiesUSP Diloxanide Furoate 7 Melting rangeUSP Diloxanide Furoate 8 AcidityUSP Diloxanide Furoate 9 Loss on DryingUSP Dimethyl Sulfoxide 1 Identification AUSP Dimethyl Sulfoxide 2 Identification BUSP Dimethyl Sulfoxide 3 Specific GravityUSP Dimethyl Sulfoxide 4 Refractive indexUSP Dimethyl Sulfoxide 5 AcidityUSP Dimethyl Sulfoxide 6 WaterUSP Dimethyl Sulfoxide 7 Ultraviolet absorptionUSP Dimethyl Sulfoxide 8 Limit of nonvolatile residueUSP Dimethyl Sulfoxide 9 Related CompoundsUSP Dimethyl Sulfoxide 10 AssayUSP Dimethyl Sulfoxide Irrigation 1 IdentificationUSP Dimethyl Sulfoxide Irrigation 2 pHUSP Dimethyl Sulfoxide Irrigation 3 AssayUSP Dissolution of Calcium <2040> 1 DissolutionUSP Dissolution of Calcium <2040> 2 ApparatusUSP Dissolution of Calcium <2040> 3 Dissolution - 1USP Dissolution of Calcium <2040> 4 Dissolution - 2USP Dissolution of Calcium <2040> 5 Dissolution - 3USP Dissolution of Calcium <2040> 6 Dissolution - 4USP Dissolution of Calcium <2040> 7 Dissolution - 5

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 138 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Dissolution of Calcium <2040> 8 Dissolution - 6

USP Dissolution of Calcium <2040> 9 Dissolution ConditionsUSP Dissolution of Calcium <2040> 10 MediumUSP Dissolution of Calcium <2040> 11 SpeedUSP Dissolution of Calcium <2040> 12 TemperatureUSP Dissolution of Calcium <2040> 13 TimeUSP Dissolution of Calcium <2040> 14 VolumeUSP Dissolution of Ferrous sulfate 1 DissolutionUSP Dissolution of Ferrous sulfate 1 ApparatusUSP Dissolution of Ferrous sulfate 2 Dissolution (1st hour) - 1USP Dissolution of Ferrous sulfate 3 Dissolution (1st hour) - 2USP Dissolution of Ferrous sulfate 4 Dissolution (1st hour) - 3USP Dissolution of Ferrous sulfate 5 Dissolution (1st hour) - 4USP Dissolution of Ferrous sulfate 6 Dissolution (1st hour) - 5USP Dissolution of Ferrous sulfate 7 Dissolution (1st hour) - 6USP Dissolution of Ferrous sulfate 8 Dissolution (2nd hour) - 1USP Dissolution of Ferrous sulfate 9 Dissolution (2nd hour) - 2USP Dissolution of Ferrous sulfate 10 Dissolution (2nd hour) - 3USP Dissolution of Ferrous sulfate 11 Dissolution (2nd hour) - 4USP Dissolution of Ferrous sulfate 12 Dissolution (2nd hour) - 5USP Dissolution of Ferrous sulfate 13 Dissolution (2nd hour) - 6USP Dissolution of Ferrous sulfate 14 Dissolution (3rd hour) - 1USP Dissolution of Ferrous sulfate 15 Dissolution (3rd hour) - 2USP Dissolution of Ferrous sulfate 16 Dissolution (3rd hour) - 3USP Dissolution of Ferrous sulfate 17 Dissolution (3rd hour) - 4USP Dissolution of Ferrous sulfate 18 Dissolution (3rd hour) - 5USP Dissolution of Ferrous sulfate 19 Dissolution (3rd hour) - 6USP Dissolution of Ferrous sulfate 20 Dissolution (4th hour) - 1USP Dissolution of Ferrous sulfate 21 Dissolution (4th hour) - 2USP Dissolution of Ferrous sulfate 22 Dissolution (4th hour) - 3USP Dissolution of Ferrous sulfate 23 Dissolution (4th hour) - 4USP Dissolution of Ferrous sulfate 24 Dissolution (4th hour) - 5USP Dissolution of Ferrous sulfate 25 Dissolution (4th hour) - 6USP Dissolution of Ferrous sulfate 26 Dissolution (5th hour) - 1USP Dissolution of Ferrous sulfate 27 Dissolution (5th hour) - 2USP Dissolution of Ferrous sulfate 28 Dissolution (5th hour) - 3USP Dissolution of Ferrous sulfate 29 Dissolution (5th hour) - 4USP Dissolution of Ferrous sulfate 30 Dissolution (5th hour) - 5USP Dissolution of Ferrous sulfate 31 Dissolution (5th hour) - 6USP Dissolution of Ferrous sulfate 32 Dissolution (6th hour) - 1USP Dissolution of Ferrous sulfate 33 Dissolution (6th hour) - 2USP Dissolution of Ferrous sulfate 34 Dissolution (6th hour) - 3USP Dissolution of Ferrous sulfate 35 Dissolution (6th hour) - 4USP Dissolution of Ferrous sulfate 36 Dissolution (6th hour) - 5USP Dissolution of Ferrous sulfate 37 Dissolution (6th hour) - 6USP Dissolution of Ferrous sulfate 38 Dissolution (7th hour) - 1USP Dissolution of Ferrous sulfate 39 Dissolution (7th hour) - 2USP Dissolution of Ferrous sulfate 40 Dissolution (7th hour) - 3USP Dissolution of Ferrous sulfate 41 Dissolution (7th hour) - 4USP Dissolution of Ferrous sulfate 42 Dissolution (7th hour) - 5USP Dissolution of Ferrous sulfate 43 Dissolution (7th hour) - 6USP Dissolution of Ferrous sulfate 44 Dissolution (8th hour) - 1

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 139 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Dissolution of Ferrous sulfate 45 Dissolution (8th hour) - 2

USP Dissolution of Ferrous sulfate 46 Dissolution (8th hour) - 3USP Dissolution of Ferrous sulfate 47 Dissolution (8th hour) - 4USP Dissolution of Ferrous sulfate 48 Dissolution (8th hour) - 5USP Dissolution of Ferrous sulfate 49 Dissolution (8th hour) - 6USP Dissolution of Ferrous sulfate 50 Dissolution (9th hour) - 1USP Dissolution of Ferrous sulfate 51 Dissolution (9th hour) - 2USP Dissolution of Ferrous sulfate 52 Dissolution (9th hour) - 3USP Dissolution of Ferrous sulfate 53 Dissolution (9th hour) - 4USP Dissolution of Ferrous sulfate 54 Dissolution (9th hour) - 5USP Dissolution of Ferrous sulfate 55 Dissolution (9th hour) - 6USP Dissolution of Ferrous sulfate 56 Dissolution (10th hour) - 1USP Dissolution of Ferrous sulfate 57 Dissolution (10th hour) - 2USP Dissolution of Ferrous sulfate 58 Dissolution (10th hour) - 3USP Dissolution of Ferrous sulfate 59 Dissolution (10th hour) - 4USP Dissolution of Ferrous sulfate 60 Dissolution (10th hour) - 5USP Dissolution of Ferrous sulfate 61 Dissolution (10th hour) - 6USP Dissolution of Ferrous sulfate 62 Dissolution ConditionsUSP Dissolution of Ferrous sulfate 63 MediumUSP Dissolution of Ferrous sulfate 64 SpeedUSP Dissolution of Ferrous sulfate 65 TemperatureUSP Dissolution of Ferrous sulfate 66 TimeUSP Dissolution of Ferrous sulfate 67 VolumeUSP Dissolution of Iron 1 DissolutionUSP Dissolution of Iron 2 ApparatusUSP Dissolution of Iron 3 Dissolution (1st hour) - 1USP Dissolution of Iron 4 Dissolution (1st hour) - 2USP Dissolution of Iron 5 Dissolution (1st hour) - 3USP Dissolution of Iron 6 Dissolution (1st hour) - 4USP Dissolution of Iron 7 Dissolution (1st hour) - 5USP Dissolution of Iron 8 Dissolution (1st hour) - 6USP Dissolution of Iron 9 Dissolution (2nd hour) - 1USP Dissolution of Iron 10 Dissolution (2nd hour) - 2USP Dissolution of Iron 11 Dissolution (2nd hour) - 3USP Dissolution of Iron 12 Dissolution (2nd hour) - 4USP Dissolution of Iron 13 Dissolution (2nd hour) - 5USP Dissolution of Iron 14 Dissolution (2nd hour) - 6USP Dissolution of Iron 15 Dissolution (3rd hour) - 1USP Dissolution of Iron 16 Dissolution (3rd hour) - 2USP Dissolution of Iron 17 Dissolution (3rd hour) - 3USP Dissolution of Iron 18 Dissolution (3rd hour) - 4USP Dissolution of Iron 19 Dissolution (3rd hour) - 5USP Dissolution of Iron 20 Dissolution (3rd hour) - 6USP Dissolution of Iron 21 Dissolution (4th hour) - 1USP Dissolution of Iron 22 Dissolution (4th hour) - 2USP Dissolution of Iron 23 Dissolution (4th hour) - 3USP Dissolution of Iron 24 Dissolution (4th hour) - 4USP Dissolution of Iron 25 Dissolution (4th hour) - 5USP Dissolution of Iron 26 Dissolution (4th hour) - 6USP Dissolution of Iron 27 Dissolution (5th hour) - 1USP Dissolution of Iron 28 Dissolution (5th hour) - 2USP Dissolution of Iron 29 Dissolution (5th hour) - 3

Page 140: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 140 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Dissolution of Iron 30 Dissolution (5th hour) - 4

USP Dissolution of Iron 31 Dissolution (5th hour) - 5USP Dissolution of Iron 32 Dissolution (5th hour) - 6USP Dissolution of Iron 33 Dissolution (6th hour) - 1USP Dissolution of Iron 34 Dissolution (6th hour) - 2USP Dissolution of Iron 35 Dissolution (6th hour) - 3USP Dissolution of Iron 36 Dissolution (6th hour) - 4USP Dissolution of Iron 37 Dissolution (6th hour) - 5USP Dissolution of Iron 38 Dissolution (6th hour) - 6USP Dissolution of Iron 39 Dissolution (7th hour) - 1USP Dissolution of Iron 40 Dissolution (7th hour) - 2USP Dissolution of Iron 41 Dissolution (7th hour) - 3USP Dissolution of Iron 42 Dissolution (7th hour) - 4USP Dissolution of Iron 43 Dissolution (7th hour) - 5USP Dissolution of Iron 44 Dissolution (7th hour) - 6USP Dissolution of Iron 45 Dissolution (8th hour) - 1USP Dissolution of Iron 46 Dissolution (8th hour) - 2USP Dissolution of Iron 47 Dissolution (8th hour) - 3USP Dissolution of Iron 48 Dissolution (8th hour) - 4USP Dissolution of Iron 49 Dissolution (8th hour) - 5USP Dissolution of Iron 50 Dissolution (8th hour) - 6USP Dissolution of Iron 51 Dissolution (9th hour) - 1USP Dissolution of Iron 52 Dissolution (9th hour) - 2USP Dissolution of Iron 53 Dissolution (9th hour) - 3USP Dissolution of Iron 54 Dissolution (9th hour) - 4USP Dissolution of Iron 55 Dissolution (9th hour) - 5USP Dissolution of Iron 56 Dissolution (9th hour) - 6USP Dissolution of Iron 57 Dissolution (10th hour) - 1USP Dissolution of Iron 58 Dissolution (10th hour) - 2USP Dissolution of Iron 59 Dissolution (10th hour) - 3USP Dissolution of Iron 60 Dissolution (10th hour) - 4USP Dissolution of Iron 61 Dissolution (10th hour) - 5USP Dissolution of Iron 62 Dissolution (10th hour) - 6USP Dissolution of Iron 63 Dissolution ConditionsUSP Dissolution of Iron 64 MediumUSP Dissolution of Iron 65 SpeedUSP Dissolution of Iron 66 TemperatureUSP Dissolution of Iron 67 TimeUSP Dissolution of Iron 68 VolumeUSP Doxylamine Succinate 1 Identification AUSP Doxylamine Succinate 2 Identification BUSP Doxylamine Succinate 3 Identification CUSP Doxylamine Succinate 4 Melting rangeUSP Doxylamine Succinate 5 Loss on DryingUSP Doxylamine Succinate 6 Residue on IgnitionUSP Doxylamine Succinate 7 AssayUSP Edetate Disodium 1 Identification AUSP Edetate Disodium 2 Identification BUSP Edetate Disodium 3 Identification CUSP Edetate Disodium 4 AssayUSP Edetate Disodium 5 Heavy MetalsUSP Edetate Disodium 6 Calcium

Page 141: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 141 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Edetate Disodium 8 pH

USP Edetate Disodium 9 Loss on Drying7 Limit of Nitrilotriacetic acid

USP Ensulizole 1 Identification AUSP Ensulizole 2 Identification BUSP Ensulizole 3 AssayUSP Enzacamene 2 Identification BUSP Enzacamene 3 Melting pointUSP Enzacamene 4 Loss on DryingUSP Enzacamene 5 Related compounds

6 Assay (dried basis)USP Fats and Fixed Oils 1 Melting temperatureUSP Fats and Fixed Oils 1 Acid ValueUSP Fats and Fixed Oils 1 Peroxide ValueUSP Fats and Fixed Oils 1 Anisidine ValueUSP Fats and Fixed Oils 1 Iodine ValueUSP Fats and Fixed Oils 1 Hydroxyl ValueUSP Fats and Fixed Oils 1 Saponification ValueUSP Fats and Fixed Oils 1 Unsaponifiable matterUSP Fats and Fixed Oils 1 Total Oxidation Value (TOTOX)USP Fats and Fixed Oils 1 Ester ValueUSP Ferric Oxide 1 IdentificationUSP Ferric Oxide 2 AssayUSP Ferric Oxide 3 Water-soluble substancesUSP Ferric Oxide 4 Acid-insoluble substancesUSP Ferric Oxide 5 Organic colors and lakesUSP Ferrous Sulfate Tablets 1 Identification AUSP Fexofenadine Hydrochloride 1 Identification AUSP Fexofenadine Hydrochloride 2 Identification BUSP Fexofenadine Hydrochloride 3 Identification CUSP Fexofenadine Hydrochloride 4 AssayUSP Fexofenadine Hydrochloride 5 Content of ChlorideUSP Fexofenadine Hydrochloride 6 Residue on IgnitionUSP Fexofenadine Hydrochloride 7 Heavy Metals IIUSP Fexofenadine Hydrochloride 8USP Fexofenadine Hydrochloride 9 Other Organic ImpuritiesUSP Fexofenadine Hydrochloride 10 WaterUSP Folic Acid 1 IdentificationUSP Folic Acid 2 AssayUSP Folic Acid 3 Residue on IgnitionUSP Folic Acid 4 Related CompoundsUSP Folic Acid 5 WaterUSP Fructose 1 Identification AUSP Fructose 2 AssayUSP Fructose 3 Residue on IgnitionUSP Fructose 4 ChlorideUSP Fructose 5 SulfateUSP Fructose 6 Calcium and Magnesium (as Calcium)USP Fructose 7 Heavy MetalsUSP Fructose 8 Limit of Hydroxymethylfurfural

USP Edetate Disodium (Limit of Nitrilotriacetic acid)

USP Enzacamene (Assay and/or Related compounds)

Limmit of Fexofenadine Related Compound B

Page 142: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 142 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Fructose 9 Color of solution

USP Fructose 10 AcidityUSP Fructose 11 Loss on DryingUSP Fumaric Acid 1 IdentificationUSP Fumaric Acid 2 AssayUSP Fumaric Acid 3 Residue on IgnitionUSP Fumaric Acid 4 Heavy MetalsUSP Fumaric Acid 5 Limit of Maleic AcidUSP Fumaric Acid 6 Water DeterminationUSP Glucosamine Hydrochloride 1 Identification AUSP Glucosamine Hydrochloride 2 Identification BUSP Glucosamine Hydrochloride 5 Residue on IgnitionUSP Glucosamine Hydrochloride 6 SulfateUSP Glucosamine Hydrochloride 7 Heavy MetalsUSP Glucosamine Hydrochloride 8 Optical rotationUSP Glucosamine Hydrochloride 9 pHUSP Glucosamine Hydrochloride 10 Loss on Drying

3 Identification C

4 Assay

1 Identification A

2 Identification B

3 Identification C

4 Identification D

5 Assay

6 Content of sulfate

7 Residue on Ignition

8 Sodium

9 Heavy Metals

10 Specific Optical Rotation

11 pH

12 Loss on DryingUSP Glutamine 1 Identification AUSP Glutamine 2 AssayUSP Glutamine 3 Residue on IgnitionUSP Glutamine 4 ChlorideUSP Glutamine 5 SulfateUSP Glutamine 6 IronUSP Glutamine 7 Heavy MetalsUSP Glutamine 8 Related compounds

USP Glucosamine Hydrochloride (ID C and/or Assay)USP Glucosamine Hydrochloride (ID C and/or Assay)USP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium ChlorideUSP Glucosamine Sulfate Potassium Chloride

Page 143: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 143 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Glutamine 9 Optical (Specific) Rotation

USP Glutamine 10 Loss on dryingUSP Glycerin 2 Identification BUSP Glycerin 4 AssayUSP Glycerin 5 ChlorideUSP Glycerin 6 SulfateUSP Glycerin 7 Heavy MetalsUSP Glycerin 8 Residue on IgnitionUSP Glycerin 10 Limit of Chlorinated CompoundsUSP Glycerin 11 Fatty Acids and EstersUSP Glycerin 12 ColorUSP Glycerin 13 Specific GravityUSP Glycerin 14 Water Determination

3 Identification C

9 Related compounds

9 Individual Impurities

9 Total impurities

Can not be performed - see supervisorUSP Glyceryl Behenate 1 Identification AUSP Glyceryl Behenate 2 Identification BUSP Glyceryl Behenate 3 Residue on IgnitionUSP Glyceryl Behenate 4 Heavy MetalsUSP Glyceryl Behenate 5 Content of 1-MonoglyceridesUSP Glyceryl Behenate 6 Limit of free glycerinUSP Glyceryl Behenate 7 Acid ValueUSP Glyceryl Behenate 8 Saponification ValueUSP Glyceryl Behenate 9 Iodine ValueUSP Glycine 2 AssayUSP Glycine 3 Residue on IgnitionUSP Glycine 4 ChlorideUSP Glycine 5 SulfateUSP Glycine 6 Heavy MetalsUSP Glycine 7 Hydrolyzable substancesUSP Glycine 8 Loss on Drying

1 Identification A

2 Residue on Ignition

3 WaterUSP Guar Gum 2 Identification BUSP Guar Gum 3 AssayUSP Guar Gum 4 Heavy MetalsUSP Guar Gum 5 Total AshUSP Guar Gum 6 Acid-Insoluble MatterUSP Guar Gum 7 ProteinUSP Guar Gum 8 StarchUSP Guar Gum 9 Loss on Drying

USP Glycerin (ID B and/or ID C and/or Related compounds)USP Glycerin (ID B and/or ID C and/or Related compounds)USP Glycerin (ID B and/or ID C and/or Related compounds)USP Glycerin (ID B and/or ID C and/or Related compounds)USP Glycerin (ID B and/or ID C and/or Related compounds)

USP Grape Seeds Oligomeric ProanthocyanidnsUSP Grape Seeds Oligomeric ProanthocyanidnsUSP Grape Seeds Oligomeric Proanthocyanidns

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 144 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Guar Gum Heavy Metals (Method I)

USP Heavy Metals <231> 1 Heavy Metals (Method I)USP Heavy Metals <231> 2 Heavy Metals (Method II)USP Heavy Metals <231> 3 Heavy Metals (Method III)USP Homosalate 1 Identification AUSP Homosalate 3 Specific GravityUSP Homosalate 4 Refractive indexUSP Homosalate (Assay) 2 AssayUSP Hydrochloric Acid 1 Identification AUSP Hydrochloric Acid 2 AssayUSP Hydrochloric Acid 3 Residue on IgnitionUSP Hydrochloric Acid 4 Heavy MetalsUSP Hydrochloric Acid 5 Bromide or IodideUSP Hydrochloric Acid 6 Free Bromine or ChlorineUSP Hydrochloric Acid 7 SulfateUSP Hydrochloric Acid 8 SulfiteUSP Hydroquinone 1 Identification AUSP Hydroquinone 2 Identification BUSP Hydroquinone 3 Identification CUSP Hydroquinone 4 Melting rangeUSP Hydroquinone 5 Residue on IgnitionUSP Hydroquinone 6 WaterUSP Hydroquinone 7 AssayUSP Hydroxyethyl Cellulose 1 Identification AUSP Hydroxyethyl Cellulose 2 Identification BUSP Hydroxyethyl Cellulose 3 Identification CUSP Hydroxyethyl Cellulose 4 Residue on IgnitionUSP Hydroxyethyl Cellulose 5 Heavy MetalsUSP Hydroxyethyl Cellulose 6 pHUSP Hydroxyethyl Cellulose 7 Loss on DryingUSP Hydroxyethyl Cellulose 8 ViscosityUSP Hypromellose 1 Identification AUSP Hypromellose 2 Identification BUSP Hypromellose 3 Identification CUSP Hypromellose 4 Identification DUSP Hypromellose 5 Identification EUSP Hypromellose 7 Residue on IgnitionUSP Hypromellose 8 Heavy MetalsUSP Hypromellose 9 pHUSP Hypromellose 10 Loss on DryingUSP Hypromellose (Assay) 6 AssayUSP Identification Tests - General <191> 2 AntimonyUSP Identification Tests - General <191> 3 BariumUSP Identification Tests - General <191> 4 BenzoateUSP Identification Tests - General <191> 5 BicarbonateUSP Identification Tests - General <191> 6 BismuthUSP Identification Tests - General <191> 7 BorateUSP Identification Tests - General <191> 8 BromideUSP Identification Tests - General <191> 9 CalciumUSP Identification Tests - General <191> 10 CarbonateUSP Identification Tests - General <191> 11 ChlorateUSP Identification Tests - General <191> 12 Chloride

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 145 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Identification Tests - General <191> 13 Citrate

USP Identification Tests - General <191> 14 CobaltUSP Identification Tests - General <191> 15 CopperUSP Identification Tests - General <191> 16 HypophosphateUSP Identification Tests - General <191> 17 IodideUSP Identification Tests - General <191> 18 IronUSP Identification Tests - General <191> 19 LactateUSP Identification Tests - General <191> 20 LeadUSP Identification Tests - General <191> 21 LithiumUSP Identification Tests - General <191> 22 MagnesiumUSP Identification Tests - General <191> 23 ManganeseUSP Identification Tests - General <191> 24 MercuryUSP Identification Tests - General <191> 25 Mercuric SaltsUSP Identification Tests - General <191> 26 Mercurous SaltsUSP Identification Tests - General <191> 27 NitrateUSP Identification Tests - General <191> 28 NitriteUSP Identification Tests - General <191> 29 OxalateUSP Identification Tests - General <191> 30 PermanganateUSP Identification Tests - General <191> 31 Peroxide USP Identification Tests - General <191> 32 PhosphateUSP Identification Tests - General <191> 33 PotassiumUSP Identification Tests - General <191> 34 SalicylateUSP Identification Tests - General <191> 35 silverUSP Identification Tests - General <191> 36 sodiumUSP Identification Tests - General <191> 37 sulfateUSP Identification Tests - General <191> 38 sulfiteUSP Identification Tests - General <191> 39 TartrateUSP Identification Tests - General <191> 40 ThiocyanateUSP Identification Tests - General <191> 41 ThiosulfateUSP Identification Tests - General <191> 42 ZincUSP Identification Tests - General <191> AcetateUSP Identification Tests - General <191> AluminiumUSP Imidurea 1 IdentificationUSP Imidurea 2 Nitrogen ContentUSP Imidurea 3 Residue on IgnitionUSP Imidurea 4 Heavy MetalsUSP Imidurea 5 pHUSP Imidurea 6 Loss on DryingUSP Imidurea 7 Color and clarity of solutionUSP Inositol 1 Identification AUSP Inositol 2 Identification BUSP Inositol 3 Assay (anhydrous basis)USP Inositol 4 BariumUSP Inositol 5 Organic ImpuritiesUSP Inositol 5 Individual ImpuritiesUSP Inositol 5 Total ImpuritiesUSP Inositol 6 Clarity of solutionUSP Inositol 7 Color of solutionUSP Inositol 8 ConductivityUSP Inositol 9 WaterUSP Ketoprofen 1 Identification AUSP Ketoprofen 2 Identification B

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 146 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Ketoprofen 3 Assay

USP Ketoprofen 4 Residue on IgnitionUSP Ketoprofen 5 Heavy MetalsUSP Ketoprofen 6 Melting rangeUSP Ketoprofen 7 Optical (Specific) RotationUSP Ketoprofen 8 Loss on DryingUSP Lactose Monohydrate 1 Identification AUSP Lactose Monohydrate 2 Identification BUSP Lactose Monohydrate 3 Residue on IgnitionUSP Lactose Monohydrate 4 Heavy MetalsUSP Lactose Monohydrate 5 Clarity and color of solutionUSP Lactose Monohydrate 6 Optical (Specific) RotationUSP Lactose Monohydrate 7 Acidity or alkalinityUSP Lactose Monohydrate 8 Loss on DryingUSP Lactose Monohydrate 9 Water DeterminationUSP Lanolin 1 Residue on IgnitionUSP Lanolin 2 ChlorideUSP Lanolin 3 Melting rangeUSP Lanolin 4 Acid ValueUSP Lanolin 5 Iodine ValueUSP Lanolin 6 AlkalinityUSP Lanolin 7 Water-Soluble Acids and AlkaliesUSP Lanolin 8 Water-soluble oxidisable substancesUSP Lanolin 9 AmmoniaUSP Lanolin 10 waterUSP Lanolin 11 PetrolatumUSP Lecithin 1 Identification AUSP Lecithin 2 Identification BUSP Lecithin 3 Assay (Acetone Insoluble Matter)USP Lecithin 4 Heavy MetalsUSP Lecithin 5 Hexane insoluble matterUSP Lecithin 6 Acid ValueUSP Lecithin 7 Peroxide ValueUSP Lecithin 8 Water DeterminationUSP Lemon Oil 1 Assay (Total Aldehyde Content)USP Lemon Oil 2 Heavy MetalsUSP Lemon Oil 3 Specific GravityUSP Lemon Oil 4 Optical (Angular) RotationUSP Lemon Oil 5 Refractive IndexUSP Lemon Oil 6 Ultraviolet absorptionUSP Lemon Oil 7 Refractive Index at 20 degreesUSP Lemon Oil 7 Foreign Oils DistillationUSP Lemon Oil 7 Angular RotationUSP Levocarnitine 1 Identification AUSP Levocarnitine 2 AssayUSP Levocarnitine 3 Residue on IgnitionUSP Levocarnitine 4 ChlorideUSP Levocarnitine 5 Heavy MetalsUSP Levocarnitine 6 Specific Optical RotationUSP Levocarnitine 7 pHUSP Levocarnitine 8 WaterUSP Loss on Drying Loss on Drying

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 147 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Loss on Drying Loss on Drying (vacuum)

USP Loss on Ignition 1 Loss on IgnitionUSP Lutein Preparation 1 Identification AUSP Lutein Preparation 2 Identification BUSP Lutein Preparation 3 Total Carotenoids as LuteinUSP Lutein Preparation 4 Content of LuteinUSP Lutein Preparation 5 Residue on IgnitionUSP Lutein Preparation 6 LeadUSP Lutein Preparation 7 Heavy MetalsUSP Lutein Preparation 8 Water DeterminationUSP Lysine Hydrochloride 1 Identification AUSP Lysine Hydrochloride 2 AssayUSP Lysine Hydrochloride 3 Content of ChlorideUSP Lysine Hydrochloride 4 Residue on IgnitionUSP Lysine Hydrochloride 5 SulfateUSP Lysine Hydrochloride 6 IronUSP Lysine Hydrochloride 7 Heavy MetalsUSP Lysine Hydrochloride 8 Related compoundsUSP Lysine Hydrochloride 9 Specific Optical RotationUSP Lysine Hydrochloride 10 Loss on DryingUSP Magnesium Aluminium Silicate 1 Identification AUSP Magnesium Aluminium Silicate 2 AluminiumUSP Magnesium Aluminium Silicate 3 MagnesiumUSP Magnesium Aluminium Silicate 4 Al/Mg ratioUSP Magnesium Aluminium Silicate 5 pHUSP Magnesium Aluminium Silicate 6 Loss on DryingUSP Magnesium Aluminium Silicate 7 ViscosityUSP Magnesium Aluminium Silicate 8 Acid DemandUSP Magnesium Chloride 1 Identification AUSP Magnesium Chloride 2 Identification BUSP Magnesium Chloride 3 AssayUSP Magnesium Chloride 4 Insoluble MatterUSP Magnesium Chloride 5 SulfateUSP Magnesium Chloride 6 BariumUSP Magnesium Chloride 7 PotassiumUSP Magnesium Chloride 8 Heavy MetalsUSP Magnesium Chloride 9 pHUSP Magnesium Citrate 1 Identification AUSP Magnesium Citrate 2 Identification BUSP Magnesium Citrate 3 AssayUSP Magnesium Citrate 4 ChlorideUSP Magnesium Citrate 5 SulfateUSP Magnesium Citrate 6 Heavy MetalsUSP Magnesium Citrate 7 IronUSP Magnesium Citrate 8 pHUSP Magnesium Citrate 9 Loss on DryingUSP Magnesium Oxide 1 Identification AUSP Magnesium Oxide 2 AssayUSP Magnesium Oxide 3 Free alkali and soluble saltsUSP Magnesium Oxide 4 Acid Insoluble SubstancesUSP Magnesium Oxide 5 Heavy MetalsUSP Magnesium Oxide 6 Iron

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 148 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Magnesium Oxide 7 Loss on ignition

USP Magnesium Oxide 8 Bulk DensityUSP Magnesium Phosphate 1 Identification AUSP Magnesium Phosphate 2 Identification BUSP Magnesium Phosphate 3 AssayUSP Magnesium Phosphate 4 Acid-insoluble substancesUSP Magnesium Phosphate 5 Soluble SubstancesUSP Magnesium Phosphate 6 CarbonateUSP Magnesium Phosphate 7 ChlorideUSP Magnesium Phosphate 8 SulfateUSP Magnesium Phosphate 9 Limit of nitrateUSP Magnesium Phosphate 10 BariumUSP Magnesium Phosphate 11 CalciumUSP Magnesium Phosphate 12 Dibasic salt and magnesium oxideUSP Magnesium Phosphate 13 Heavy MetalsUSP Magnesium Phosphate 14 Loss on IgnitionUSP Magnesium Stearate 1 Identification AUSP Magnesium Stearate 2 Identification BUSP Magnesium Stearate 3 AssayUSP Magnesium Stearate 4 ChlorideUSP Magnesium Stearate 5 SulfateUSP Magnesium Stearate 6 Acidity or alkalinityUSP Magnesium Stearate 7 Loss on DryingUSP Magnesium Stearate 8USP Magnesium Stearate 8 Stearate PeakUSP Magnesium Stearate 8 Sum of the Stearate and Palmitate PeaksUSP Malic Acid 1 Identification AUSP Malic Acid 2 AssayUSP Malic Acid 3 Residue on IgnitionUSP Malic Acid 4 Heavy MetalsUSP Malic Acid 5 Fumaric and Maleic AcidsUSP Malic Acid 5 Fumaric AcidUSP Malic Acid 5 Maleic AcidUSP Malic Acid 6 Water Insoluble substancesUSP Maltodextrin 1 Dextrose Equivalent AssayUSP Maltodextrin 2 Residue on IgnitionUSP Maltodextrin 3 Heavy MetalsUSP Maltodextrin 4 Limit of proteinUSP Maltodextrin 5 Limit of sulfur dioxideUSP Maltodextrin 6 pHUSP Maltodextrin 7 Loss on DryingUSP Maltol 1 Identification AUSP Maltol 2 Identification BUSP Maltol 3 AssayUSP Maltol 4 Residue on IgnitionUSP Maltol 5 Heavy MetalsUSP Maltol 6 Melting rangeUSP Maltol 7 Water DeterminationUSP Mannitol 1 IdentificationUSP Mannitol 3 ChlorideUSP Mannitol 4 Sulfate

Relative Content of Stearic & Palmitic Acid

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 149 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Mannitol 5 Melting range

USP Mannitol 6 Specific rotationUSP Mannitol 7 AcidityUSP Mannitol 8 Loss on dryingUSP Mannitol (Assay) 2 AssayUSP Melting Range or Temperature Melting rangeUSP Melting Range or Temperature Meling TemperatureUSP meso-Zeaxanthin 1 Identification AUSP meso-Zeaxanthin 2 Identification BUSP meso-Zeaxanthin 3 Identification CUSP meso-Zeaxanthin 4 Content of Total CarotenoidsUSP meso-Zeaxanthin 5 Content of ZeaxanthinUSP meso-Zeaxanthin 6 Lutein and Other Related CompoundsUSP meso-Zeaxanthin 6 Other related compoundsUSP meso-Zeaxanthin 6 Lutein contentUSP meso-Zeaxanthin 7 Stereoisomeric CompositionUSP meso-Zeaxanthin 8 Residue on IgnitionUSP meso-Zeaxanthin 9 Water DeterminationUSP Methoxyflurane 1 Identification AUSP Methoxyflurane 2 Identification BUSP Methoxyflurane 3 Identification CUSP Methoxyflurane 4 Specific GravityUSP Methoxyflurane 5 AcidityUSP Methoxyflurane 6 WaterUSP Methoxyflurane 7 Limit of Non - Volatile ResidueUSP Methoxyflurane 8 AssayUSP Methyl Alcohol 1 Identification AUSP Methyl Alcohol 3 Nonvolatile ResidueUSP Methyl Alcohol 4 Acetone & AldehydesUSP Methyl Alcohol 5 Readily carbonizable substancesUSP Methyl Alcohol 6 Readily oxidizable substancesUSP Methyl Alcohol 7 AcidityUSP Methyl Alcohol 8 AlkalinityUSP Methyl Alcohol 9 Water DeterminationUSP Methyl Alcohol (ID B and/or Assay) 2 Identification BUSP Methyl Alcohol (ID B and/or Assay) 3 AssayUSP Methylsulfonylmethane 1 Identification AUSP Methylsulfonylmethane 2 Identification BUSP Methylsulfonylmethane 3 AssayUSP Methylsulfonylmethane 4 Heavy MetalsUSP Methylsulfonylmethane 5USP Methylsulfonylmethane 5 Individual ImpuritiesUSP Methylsulfonylmethane 5 Total impuritiesUSP Methylsulfonylmethane 6 Melting rangeUSP Methylsulfonylmethane 7 Water DeterminationUSP Microcrystalline Wax 1 Residue on IgnitionUSP Microcrystalline Wax 2 ColorUSP Microcrystalline Wax 3 Melting rangeUSP Microcrystalline Wax 4 Organic AcidsUSP Microcrystalline Wax 5 Fixed Oils, Fats, and RosinUSP Microcrystalline Wax 6 Alkalinity

Chromatographic Purity & Limit of Dimethyl Sulfoxide

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 150 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Microcrystalline Wax 7 Acidity

USP Midodrine Hydrochloride 1 Identification AUSP Midodrine Hydrochloride 2 Identification BUSP Midodrine Hydrochloride 3 Identification CUSP Midodrine Hydrochloride 4 AssayUSP Midodrine Hydrochloride 5 residue on IgnitionUSP Midodrine Hydrochloride 6 Heavy MetalsUSP Midodrine Hydrochloride 7 Organic ImpuritiesUSP Midodrine Hydrochloride 7 Impurity AUSP Midodrine Hydrochloride 7 Individual unspecified ImpuritiyUSP Midodrine Hydrochloride 7 TotalUSP Midodrine Hydrochloride 8 waterUSP Midodrine Hydrochloride 9 pHUSP Mineral Oil 1 Identification AUSP Mineral Oil 2 Identification BUSP Mineral Oil 3USP Mineral Oil 4 Specific GravityUSP Mineral Oil 5 ViscosityUSP Mineral Oil 6 AcidityUSP Mineral Oil 7 Readily carbonizable substancesUSP Mineral Oil 8 Solid paraffinsUSP Mineral Oil 9 Limit of sulfur compoundsUSP Naproxen 1 Identification AUSP Naproxen 2 Identification BUSP Naproxen 3 Specific Optical RotationUSP Naproxen 4 Loss on DryingUSP Naproxen 5 Heavy MetalsUSP Naproxen 6 Chromatographic purityUSP Naproxen 7 AssayUSP Naproxen 7 Assay (dried basis)USP Niacinamide 1 Identification AUSP Niacinamide 2 Identification BUSP Niacinamide 3 AssayUSP Niacinamide 4 Residue on IgnitionUSP Niacinamide 5 Heavy MetalsUSP Niacinamide 6 Readily carbonizable substancesUSP Niacinamide 7 Melting RangeUSP Niacinamide 8 Loss on DryingUSP Octinoxate 1 Identification AUSP Octinoxate 2 Identification BUSP Octinoxate 3 Specific GravityUSP Octinoxate 4 Refractive IndexUSP Octinoxate 5 AcidityUSP Octinoxate 6 Limits

6 Chromatographic purity

7 AssayUSP Octisalate 2 Identification AUSP Octisalate 2 Identification BUSP Octisalate 3 Specific GravityUSP Octisalate 4 Refractive indexUSP Octisalate 5 Acidity

Limit of polycyclic aromatic hydrocarbons

USP Octinoxate (Assay and/or Chromatographic purity)USP Octinoxate (Assay and/or Chromatographic purity)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 151 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Octisalate 6 Chromatographic purity

6 Individual Impurity

6 Total

7 AssayUSP Octocrylene 1 IdentificationUSP Octocrylene 2 Specific GravityUSP Octocrylene 3 Refractive indexUSP Octocrylene 4 AcidityUSP Octocrylene 5 Chromatographic purity

5 Individual Impurities

5 Total Impurities

6 AssayUSP Oxybenzone 1 Identification AUSP Oxybenzone 2 Identification BUSP Oxybenzone 3 AssayUSP Oxybenzone 4 Congealing temperatureUSP Oxybenzone 5 Loss on DryingUSP Oxytocin 1 Identification AUSP Oxytocin 2 Identification BUSP Oxytocin 3 Identification CUSP Oxytocin 4 Acetic Acid ContentUSP Oxytocin 5 Ordinary ImpuritiesUSP Oxytocin 6 AssayUSP Padimate O 1 Identification AUSP Padimate O 2 Identification BUSP Padimate O 3 Specific GravityUSP Padimate O 4 Refractive indexUSP Padimate O 5 Acid ValueUSP Padimate O 6 Saponification ValueUSP Padimate O 8 AssayUSP Padimate O (Chromatographic purity) 7 Chromatographic purityUSP Padimate O (Chromatographic purity) 7 LimitsUSP Palm Oil 1 Identification AUSP Palm Oil 2 Identification BUSP Palm Oil 3 Residue on IgnitionUSP Palm Oil 4 Heavy MetalsUSP Palm Oil 5 Alkaline ImpuritiesUSP Palm Oil 6 Melting rangeUSP Palm Oil 7 Acid ValueUSP Palm Oil 8 Fatty Acid CompositionUSP Palm Oil 8 Carbon-Chain Length less or equal to 12USP Palm Oil 8 C16:0USP Palm Oil 8 C18:0USP Palm Oil 8 C18:2USP Palm Oil 8USP Palm Oil 8 C14:0

USP Octisalate (Assay and/or Chromatographic purity)USP Octisalate (Assay and/or Chromatographic purity)USP Octisalate (Assay and/or Chromatographic purity)

USP Octocrylene (Assay and/or Chromatographic purity)USP Octocrylene (Assay and/or Chromatographic purity)USP Octocrylene (Assay and/or Chromatographic purity)

Carbon-Chain Length greater than or equal to 20

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 152 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Palm Oil 8 C16:1

USP Palm Oil 8 C18:1USP Palm Oil 8 C18:3USP Palm Oil 9 Peroxide ValueUSP Palm Oil 10 Unsaponifiable matterUSP Palm Oil 11 Water DeterminationUSP Panthenol 2 Identification BUSP Panthenol 3 Identification CUSP Panthenol 4 AssayUSP Panthenol 5 Residue on IgnitionUSP Panthenol 6 Limit of aminopropanolUSP Panthenol 7 Melting rangeUSP Panthenol 8 Optical (Specific) RotationUSP Panthenol 9 Loss on DryingUSP Panthenol Identification AUSP Peanut Oil 1 IdentificationUSP Peanut Oil 2 heavy metals IIUSP Peanut Oil 3 Alkaline ImpuritiesUSP Peanut Oil 4 Fatty Acid CompositionUSP Peanut Oil 5 RancidityUSP Peanut Oil 6 Acid ValueUSP Peanut Oil 7 Peroxide ValueUSP Peanut Oil 8 Unsaponifiable matterUSP Peanut Oil 9 WaterUSP Phosphoric Acid 1 IdentificationUSP Phosphoric Acid 2 AssayUSP Phosphoric Acid 3 Heavy MetalsUSP Phosphoric Acid 4 Limit of nitrateUSP Phosphoric Acid 5 SulfateUSP Phosphoric Acid 6 Alkali PhosphatesUSP Phosphoric Acid 7 Phosphorous or Hypophosphorous AcidUSP Poloxamer 1 Identification AUSP Poloxamer 2 Average Molecular WeightUSP Poloxamer 3 Heavy MetalsUSP Poloxamer 4USP Poloxamer 4 Propylene OxideUSP Poloxamer 4 Ethylene oxideUSP Poloxamer 4 1,4-DioxaneUSP Polyethylene Glycol 1 Average Molecular WeightUSP Polyethylene Glycol 2 Residue on IgnitionUSP Polyethylene Glycol 3 Heavy MetalsUSP Polyethylene Glycol 5

USP Polyethylene Glycol 6USP Polyethylene Glycol 7 pHUSP Polyethylene Glycol 8 Completeness and Colour of SolutionUSP Polyethylene Glycol 9 Viscosity

4

4 ethylene Oxide

Limit of Free Ethylene Oxide, Propylene Oxide and 1,4-dioxane

Limit of ethylene glycol and diethylene glycolLimit of ethylene glycol and diethylene glycoln (MW > 450)

USP Polyethylene Glycol (Limit of Residual solvents)

Limit of free ethylene oxide and 1,4-dioxane

USP Polyethylene Glycol (Limit of Residual solvents)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 153 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

4 1,4- Dioxane

1 Completeness of Solution

2 Identification A

3 Identification B

4 pH

5 Uniformity of Dosage Units

6 Osmolarity

7 Assay for Bicarbonate

8 Assay for Polyethylene Glycol 3350USP Polysorbate 80 3 Residue on IgnitionUSP Polysorbate 80 4 Heavy MetalsUSP Polysorbate 80 6 Specific GravityUSP Polysorbate 80 7 Viscosity (Rotational)USP Polysorbate 80 7 Viscosity (Capillary)USP Polysorbate 80 8 Acid ValueUSP Polysorbate 80 9 Hydroxyl ValueUSP Polysorbate 80 11 Peroxide ValueUSP Polysorbate 80 12 Saponification ValueUSP Polysorbate 80 13 Water Determination

1 Identification

2 Assay (Composition of fatty acids)

2 Myristic acid

2 Palmitic acid

2 Palmitoleic acid

2 Stearic acid

2 Linolenic acid

2 Linoleic Acid

2 Oleic acid

5 Ethylene oxide and dioxane

5 Ethylene Oxide

5 1,4-DioxaneUSP Potassium Chloride 1 Identification AUSP Potassium Chloride 2 Identification B

USP Polyethylene Glycol (Limit of Residual solvents)USP Polyethylene Glycol 3350 and Electrolytes for Oral SolutionUSP Polyethylene Glycol 3350 and Electrolytes for Oral SolutionUSP Polyethylene Glycol 3350 and Electrolytes for Oral SolutionUSP Polyethylene Glycol 3350 and Electrolytes for Oral SolutionUSP Polyethylene Glycol 3350 and Electrolytes for Oral SolutionUSP Polyethylene Glycol 3350 and Electrolytes for Oral SolutionUSP Polyethylene Glycol 3350 and Electrolytes for Oral SolutionUSP Polyethylene Glycol 3350 and Electrolytes for Oral Solution

USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)USP Polysorbate 80 (ID and/or Composition of fatty acids)

Page 154: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 154 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Potassium Chloride 3 Assay

USP Potassium Chloride 4 AluminiumUSP Potassium Chloride 5 SodiumUSP Potassium Chloride 6 IodideUSP Potassium Chloride 7 BromideUSP Potassium Chloride 8 Calcium and MagnesiumUSP Potassium Chloride 9 Heavy MetalsUSP Potassium Chloride 10 Acidity or alkalinityUSP Potassium Chloride 11 Loss on DryingUSP Potassium Gluconate 1 Identification AUSP Potassium Gluconate 2 Identification BUSP Potassium Gluconate 3 Identification CUSP Potassium Gluconate 4 Heavy MetalsUSP Potassium Gluconate 5 Reducing SubstancesUSP Potassium Gluconate 6 Loss on DryingUSP Potassium Hydroxide 1 Identification AUSP Potassium Hydroxide 2 AssayUSP Potassium Hydroxide 2 Potassium CarbonateUSP Potassium Hydroxide 3 Heavy MetalsUSP Potassium Hydroxide 4 Insoluble SubstancesUSP Povidone 2 Identification BUSP Povidone 2 Identification AUSP Povidone 3 Identification CUSP Povidone 4 Identification DUSP Povidone 5 Identification EUSP Povidone 6USP Povidone 7 Residue on IgnitionUSP Povidone 8 Limit of AldehydesUSP Povidone 9 Limit of HydrazineUSP Povidone 10 VinylpyrrolidinoneUSP Povidone 11 2-PyrrolidoneUSP Povidone 12 PeroxidesUSP Povidone 13 pHUSP Povidone 14 Water DeterminationUSP Povidone 15 K-ValueUSP Povidone-Iodine 1 Identification AUSP Povidone-Iodine 2 Identification BUSP Povidone-Iodine 3 Assay (Available Iodine content)USP Povidone-Iodine 4 Iodide ionUSP Povidone-Iodine 5 Nitrogen ContentUSP Povidone-Iodine 6 Residue on IgnitionUSP Povidone-Iodine 7 Heavy MetalsUSP Povidone-Iodine 8 Loss on DryingUSP Powdered Asian Ginseng Extract 1 Identification AUSP Powdered Asian Ginseng Extract 2 Identification BUSP Powdered Asian Ginseng Extract 3 Content of GinsenosidesUSP Powdered Asian Ginseng Extract 3 Identification CUSP Powdered Asian Ginseng Extract 4 Heavy MetalsUSP Powdered Asian Ginseng Extract 5 Loss on DryingUSP Powdered Bilberry Extract 1 Identification AUSP Powdered Bilberry Extract 2 Identification B

Assay - Nitrogen Determination (Method II)

Page 155: [XLS] · Web viewCalcium Ascorbate dihydrate (HPLC) Fatty Acids Chromatographic Profile d-alpha Tocopherol GLA (Gamma Linolenic Acid) Linolenic Acid ALA (Alpha Linolenic Acid) Oleic

005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 155 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

USP Powdered Bilberry Extract 3USP Powdered Bilberry Extract 3 Sum of all anthocyanosidesUSP Powdered Bilberry Extract 3 Sum of all anthocyanidinsUSP Powdered Bilberry Extract 4 Heavy MetalsUSP Powdered Bilberry Extract 5 Water DeterminationUSP Powdered Bilberry Extract 6 Residue on IgnitionUSP Powdered Cellulose 1 Identification AUSP Powdered Cellulose 2 Identification BUSP Powdered Cellulose 3 Residue on IgnitionUSP Powdered Cellulose 4 Heavy MetalsUSP Powdered Cellulose 5 pHUSP Powdered Cellulose 6 Loss on DryingUSP Powdered Cellulose 7 Water-soluble substancesUSP Powdered Cellulose 8 Ether-soluble substances

1 Identification A

2 Identification B

3 Content of Polyphenols

3 (-)-epigallocatechin-3-O-gallate

3 Polyphenols

4 Heavy Metals

5 Limit of Gallic Acid

6 Limit of Caffeine

7 Water

8 Residue on IgnitionUSP Powdered Eleuthero Extract 1 Identification AUSP Powdered Eleuthero Extract 4 Heavy MetalsUSP Powdered Eleuthero Extract 5 Water DeterminationUSP Powdered Eleuthero Extract 6 Total Ash

2 Identification B

3 Content of Eleutherosides B and E

3 Eleutheroside E

3 Eleutheroside BUSP Powdered Garlic Extract 1 Identification AUSP Powdered Garlic Extract 4 water Content

2 Identification B

3 Content of Alliin

Content of Anthocyanosides and Anthocyanidins

USP Powdered Decaffeinated Green Tea ExtractUSP Powdered Decaffeinated Green Tea ExtractUSP Powdered Decaffeinated Green Tea ExtractUSP Powdered Decaffeinated Green Tea ExtractUSP Powdered Decaffeinated Green Tea ExtractUSP Powdered Decaffeinated Green Tea ExtractUSP Powdered Decaffeinated Green Tea ExtractUSP Powdered Decaffeinated Green Tea ExtractUSP Powdered Decaffeinated Green Tea ExtractUSP Powdered Decaffeinated Green Tea Extract

USP Powdered Eleuthero Extract (ID B and/or Assay)USP Powdered Eleuthero Extract (ID B and/or Assay)USP Powdered Eleuthero Extract (ID B and/or Assay)USP Powdered Eleuthero Extract (ID B and/or Assay)

USP Powdered Garlic Extract (Content of Alliin)USP Powdered Garlic Extract (Content of Alliin)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 156 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

5 Alliinase activity

5 Alliinase activity (5 minutes)

5 Alliinase activity (30 minutes)USP Powdered Ginkgo Extract 1 Identification AUSP Powdered Ginkgo Extract 6 Loss on Drying

2 Identification B

3 Flavonol Glycosides

4 Content of Terpene Lactones

5 Ginkgolic AcidUSP Powdered Soy Isoflavones Extract 3 Heavy MetalsUSP Powdered Soy Isoflavones Extract 4 loss on Drying

1 Identification A

2 Content of Isoflavones

2 Glycitein

2 Genistein

2 Daidzein

2 Glycitin

2 Genistin

2 DaidzinUSP Powdered St. Johns Wort Extract 1 Identification AUSP Powdered St. Johns Wort Extract 2 Identification BUSP Powdered St. Johns Wort Extract 3 Content of Hypericin & PseudohypericinUSP Powdered St. Johns Wort Extract 4 Content of HyperforinUSP Powdered St. Johns Wort Extract 5 Heavy MetalsUSP Powdered St. Johns Wort Extract 6 Water DeterminationUSP Powdered St. Johns Wort Extract 7 Total AshUSP Powdered Turmeric Extract 1 Identification AUSP Powdered Turmeric Extract 4 Heavy MetalsUSP Powdered Turmeric Extract 5 Loss on Drying

2 Identification B

3 Content of Curcuminoids

3 Curcumin

3 Total Curcuminoids

3 Desmethoxycurcumin

USP Powdered Garlic Extract (Content of Alliin)USP Powdered Garlic Extract (Content of Alliin)USP Powdered Garlic Extract (Content of Alliin)

USP Powdered Ginkgo Extract (ID B and/or Assay)USP Powdered Ginkgo Extract (ID B and/or Assay)USP Powdered Ginkgo Extract (ID B and/or Assay)USP Powdered Ginkgo Extract (ID B and/or Assay)

USP Powdered Soy Isoflavones Extract (ID A and/or Isoflavones)USP Powdered Soy Isoflavones Extract (ID A and/or Isoflavones)USP Powdered Soy Isoflavones Extract (ID A and/or Isoflavones)USP Powdered Soy Isoflavones Extract (ID A and/or Isoflavones)USP Powdered Soy Isoflavones Extract (ID A and/or Isoflavones)USP Powdered Soy Isoflavones Extract (ID A and/or Isoflavones)USP Powdered Soy Isoflavones Extract (ID A and/or Isoflavones)USP Powdered Soy Isoflavones Extract (ID A and/or Isoflavones)

USP Powdered Turmeric Extract (ID B and/or Assay)USP Powdered Turmeric Extract (ID B and/or Assay)USP Powdered Turmeric Extract (ID B and/or Assay)USP Powdered Turmeric Extract (ID B and/or Assay)USP Powdered Turmeric Extract (ID B and/or Assay)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 157 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

3 BisdesmethoxycurcuminUSP Praziquantel 1 Identification AUSP Praziquantel 2 Identification BUSP Praziquantel 3 AssayUSP Praziquantel 4 Residue on IgnitionUSP Praziquantel 5 Limit of PhosphateUSP Praziquantel 6 Heavy MetalsUSP Praziquantel 7 Organic ImpuritiesUSP Praziquantel 8 Loss on DryingUSP Progesterone 1 Identification AUSP Progesterone 2 Identification BUSP Progesterone 3 Melting RangeUSP Progesterone 4 Specific RotationUSP Progesterone 5 Loss on DryingUSP Progesterone 6 AssayUSP Propylene Carbonate 1 Identification AUSP Propylene Carbonate 2 AssayUSP Propylene Carbonate 3 Residue on IgnitionUSP Propylene Carbonate 4 Specific GravityUSP Propylene Carbonate 5 pHUSP Propylene Glycol 1 Identification AUSP Propylene Glycol 5 Residue on IgnitionUSP Propylene Glycol 6 ChlorideUSP Propylene Glycol 7 SulfateUSP Propylene Glycol 8 Heavy MetalsUSP Propylene Glycol 9 Specific GravityUSP Propylene Glycol 10 AcidityUSP Propylene Glycol 11 Water Determination

2

2 Diethylene glycol

2 Ethylene glycol

3 Identification C

4 Assay

USP Propylene Glycol Monolaurate 1 Identification AUSP Propylene Glycol Monolaurate 3 Acid ValueUSP Propylene Glycol Monolaurate 5 Iodine ValueUSP Propylene Glycol Monolaurate 6 Saponification ValueUSP Propylene Glycol Monolaurate 7 WaterUSP Propylene Glycol Monolaurate 8 Total Ash

2 Identification B

USP Powdered Turmeric Extract (ID B and/or Assay)

USP Propylene Glycol (IDB and/or ID C and/or Diethylene glycol and/or Ethylene glycol)

Identification B (Limit of Diethylene glycol and Ethylene glycol)

USP Propylene Glycol (IDB and/or ID C and/or Diethylene glycol and/or Ethylene glycol)USP Propylene Glycol (IDB and/or ID C and/or Diethylene glycol and/or Ethylene glycol)USP Propylene Glycol (IDB and/or ID C and/or Diethylene glycol and/or Ethylene glycol)USP Propylene Glycol (IDB and/or ID C and/or Diethylene glycol and/or Ethylene glycol)

USP Propylene Glycol Monolaurate (Fatty acid composition)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 158 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

4 Fatty Acid Composition

4 Myristic acid

4 Palmitic acid

4 Caprylic acid

4 Capric acid

4 Lauric acidUSP Psyllium Husk 1 Heavy MetalsUSP Psyllium Husk 2 Total AshUSP Psyllium Husk 3 Water DeterminationUSP Purified Honey 1 ChlorideUSP Purified Honey 2 SulfateUSP Purified Honey 3 Total AshUSP Purified Honey 4 Specific GravityUSP Purified Honey 5 Refractive indexUSP Purified Honey 6 Water DeterminationUSP Purified Siliceous Earth 1 Loss on ignitionUSP Purified Siliceous Earth 2 Limit of nonsiliceous substancesUSP Purified Siliceous Earth 3 Loss on dryingUSP Purified Siliceous Earth 4 Acid-soluble substancesUSP Purified Siliceous Earth 5 Water-soluble substancesUSP Pygeum Extract Identification AUSP Pyrantel Pamoate 1 Identification AUSP Pyrantel Pamoate 2 Identification BUSP Pyrantel Pamoate 6 Limit of IronUSP Pyrantel Pamoate 7 Residue on IgnitionUSP Pyrantel Pamoate 8 Heavy MetalsUSP Pyrantel Pamoate 10 Loss on Drying

3 Identification C

4 Assay (dried basis)

5 Content of Pamoic Acid

9 Organic Impurities

9 Impurity B

9 Total Unspecified Impurities

9 Any other unspecified impurity

9 Pyrantel related compound A

9 Pyrantel (E-isomer)USP Pyridoxine Hydrochloride 1 Identification AUSP Pyridoxine Hydrochloride 2 Identification B

USP Propylene Glycol Monolaurate (Fatty acid composition)USP Propylene Glycol Monolaurate (Fatty acid composition)USP Propylene Glycol Monolaurate (Fatty acid composition)USP Propylene Glycol Monolaurate (Fatty acid composition)USP Propylene Glycol Monolaurate (Fatty acid composition)USP Propylene Glycol Monolaurate (Fatty acid composition)

USP Pyrantel Pamoate (Pamoic acid and/or Assay and/or Organic impurities)USP Pyrantel Pamoate (Pamoic acid and/or Assay and/or Organic impurities)USP Pyrantel Pamoate (Pamoic acid and/or Assay and/or Organic impurities)USP Pyrantel Pamoate (Pamoic acid and/or Assay and/or Organic impurities)USP Pyrantel Pamoate (Pamoic acid and/or Assay and/or Organic impurities)USP Pyrantel Pamoate (Pamoic acid and/or Assay and/or Organic impurities)USP Pyrantel Pamoate (Pamoic acid and/or Assay and/or Organic impurities)USP Pyrantel Pamoate (Pamoic acid and/or Assay and/or Organic impurities)USP Pyrantel Pamoate (Pamoic acid and/or Assay and/or Organic impurities)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 159 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Pyridoxine Hydrochloride 3 Assay

USP Pyridoxine Hydrochloride 4 Residue on IgnitionUSP Pyridoxine Hydrochloride 5 Heavy MetalsUSP Pyridoxine Hydrochloride 6 Content of chlorideUSP Pyridoxine Hydrochloride 7 Loss on DryingUSP Residual Solvents Residual SolventtsUSP Residual Solvents Acetic AcidUSP Residual Solvents Ethylene glycolUSP Residual Solvents IsopropanolUSP Residual Solvents DimethylformamideUSP Residual Solvents triisopropylsilaneUSP Residual Solvents Diethyl EtherUSP Residual Solvents Methylene chlorideUSP Residual Solvents 1,2-DichloroethaneUSP Residual Solvents 1,1,1-TrichloroethaneUSP Residual Solvents AcetoneUSP Residual Solvents EthanolUSP Residual Solvents BenzeneUSP Residual Solvents MethanolUSP Residual Solvents HexaneUSP Residual Solvents DichloromethaneUSP Residual Solvents 1,4-DioxaneUSP Residual Solvents ChloroformUSP Residual Solvents AcetonitrileUSP Residual Solvents Ethyl acetateUSP Residual Solvents CyclohexaneUSP Residual Solvents Carbon TetrachlorideUSP Residual Solvents 1,1-DichloroetheneUSP Residual Solvents Methyl isobutyl ketoneUSP Residual Solvents TrichloroethyleneUSP Residual Solvents TolueneUSP Residual Solvents Isopropyl EtherUSP Residual Solvents 1-PropanolUSP Residue on Ignition 1 Residue on IgnitionUSP Riboflavin 1 Identification AUSP Riboflavin 2 AssayUSP Riboflavin 3 Residue on IgnitionUSP Riboflavin 4 Limit of lumiflavinUSP Riboflavin 5 Optical (Specific) RotationUSP Riboflavin 6 Loss on DryingUSP Riboflavin 5-Phosphate Sodium 1 Identification AUSP Riboflavin 5-Phosphate Sodium 2 Identification BUSP Riboflavin 5-Phosphate Sodium 3 AssayUSP Riboflavin 5-Phosphate Sodium 4 Free phosphateUSP Riboflavin 5-Phosphate Sodium 5 Limit of lumiflavinUSP Riboflavin 5-Phosphate Sodium 6 Residue on IgnitionUSP Riboflavin 5-Phosphate Sodium 7 Optical (Specific) RotationUSP Riboflavin 5-Phosphate Sodium 8 pHUSP Riboflavin 5-Phosphate Sodium 9 Loss on DryingUSP Salicylic Acid 1 IdentificationUSP Salicylic Acid 2 Melting rangeUSP Salicylic Acid 3 Loss on Drying

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 160 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Salicylic Acid 4 Residue on Ignition

USP Salicylic Acid 5 ChlorideUSP Salicylic Acid 6 SulfateUSP Salicylic Acid 7 Heavy MetalsUSP Salicylic Acid 8 AssayUSP Selenomethionine 1 Identification by Infrared AbsorptionUSP Selenomethionine 3 Heavy MetalsUSP Selenomethionine 4 Chromatographic purityUSP Selenomethionine 5 Specific rotationUSP Selenomethionine (Assay) 2 AssayUSP Sennosides 1 Identification AUSP Sennosides 2 AssayUSP Sennosides 3 Heavy metals Method IIUSP Sennosides 4 pHUSP Sennosides 5 Residue on IgnitionUSP Sennosides 6 Loss on DryingUSP Sesame Oil 1 Identification AUSP Sesame Oil 2 Assay (Triglyceride Composition)USP Sesame Oil 3 Heavy MetalsUSP Sesame Oil 4 Specific GravityUSP Sesame Oil 5 Acid ValueUSP Sesame Oil 6 Iodine ValueUSP Sesame Oil 7 Saponification ValueUSP Sesame Oil 8 Solidification Temperature of Fatty AcidsUSP Sesame Oil 9 Unsaponifiable matterUSP Sesame Oil 10 Cottonseed oilUSP Sildenafil Citrate 1 Identification (FTIR)USP Sildenafil Citrate 2 AssayUSP Sildenafil Citrate 3 Heavy Metals (Method II)USP Sildenafil Citrate 4 Residue on IgnitionUSP Sildenafil Citrate 5 Limit of ImidazoleUSP Sildenafil Citrate 6 Organic ImpuritiesUSP Sildenafil Citrate 6 Related Compound AUSP Sildenafil Citrate 6 Any other unspecified impurityUSP Sildenafil Citrate 6 Total Unspecified ImpuritiesUSP Sildenafil Citrate 6 Total ImpuritiesUSP Sildenafil Citrate 7 Water (Karl Fischer)USP Silicon Dioxide 1 IdentificationUSP Silicon Dioxide 2 AssayUSP Silicon Dioxide 3 Loss on ignitionUSP Silicon Dioxide 4 ChlorideUSP Silicon Dioxide 5 SulfateUSP Silicon Dioxide 5 Heavy MetalsUSP Silicon Dioxide 6 pHUSP Silicon Dioxide 7 Loss on DryingUSP Simethicone 1 Identification by Infrared AbsorptionUSP Simethicone 2 AssayUSP Simethicone 3 Silicon DioxideUSP Simethicone 4 Heavy MetalsUSP Simethicone 5 Loss on heatingUSP Simethicone 6 Defoaming activityUSP Simethicone Emulsion 1 Identification by Infrared Absorption

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 161 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Simethicone Emulsion 2 Assay

USP Simethicone Emulsion 3 Heavy MetalsUSP Simethicone Emulsion 4 Defoaming activityUSP Sodium Bicarbonate 1 Identification AUSP Sodium Bicarbonate 2 Identification BUSP Sodium Bicarbonate 3 AssayUSP Sodium Bicarbonate 4 Insoluble SubstancesUSP Sodium Bicarbonate 5 Carbonate (Normal)USP Sodium Bicarbonate 6 ChlorideUSP Sodium Bicarbonate 7 Limit of sulfur compoundsUSP Sodium Bicarbonate 8 AluminiumUSP Sodium Bicarbonate 9 IronUSP Sodium Bicarbonate 10 Heavy MetalsUSP Sodium Bicarbonate 11 Limit of AmmoniaUSP Sodium Bicarbonate 12 Loss on DryingUSP Sodium Bicarbonate 12 Limit of OrganicsUSP Sodium Chloride 2 Identification BUSP Sodium Chloride 3 AssayUSP Sodium Chloride 4 AluminumUSP Sodium Chloride 5 BariumUSP Sodium Chloride 6 FerrocyanidesUSP Sodium Chloride 7 IodidesUSP Sodium Chloride 8 IronUSP Sodium Chloride 9 Limit of BromidesUSP Sodium Chloride 11 Magnesium and alkaline-earth metalsUSP Sodium Chloride 12 NitritesUSP Sodium Chloride 13 SulfateUSP Sodium Chloride 14 Heavy MetalsUSP Sodium Chloride 15 Appearance of solutionUSP Sodium Chloride 16 Acidity or alkalinityUSP Sodium Chloride 17 Loss on dryingUSP Sodium Citrate 1 Identification AUSP Sodium Citrate 2 Identification BUSP Sodium Citrate 3 Identification CUSP Sodium Citrate 4 AssayUSP Sodium Citrate 5 Heavy MetalsUSP Sodium Citrate 6 TartrateUSP Sodium Citrate 7 AlkalinityUSP Sodium Citrate 8 Water DeterminationUSP Sodium Hydroxide 1 Identification AUSP Sodium Hydroxide 2 AssayUSP Sodium Hydroxide 3 PotassiumUSP Sodium Hydroxide 4 Heavy MetalsUSP Sodium Hydroxide 5 Insoluble substances and organic matterUSP Sodium Hypochlorite Solution 1 Identification AUSP Sodium Hypochlorite Solution 2 Identification BUSP Sodium Hypochlorite Solution 3 Identification CUSP Sodium Hypochlorite Solution 4 AssayUSP Sodium Lactate Solution 1 IdentificationUSP Sodium Lactate Solution 2 pHUSP Sodium Lactate Solution 3 ChlorideUSP Sodium Lactate Solution 4 Sulfate

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 162 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Sodium Lactate Solution 5 Heavy Metals

USP Sodium Lactate Solution 6 SugarsUSP Sodium Lactate Solution 7USP Sodium Lactate Solution 8 Limit of methanol and methyl estersUSP Sodium Lactate Solution 9 AssayUSP Sodium Lauryl Sulfate 1 Identification AUSP Sodium Lauryl Sulfate 2 Identification BUSP Sodium Lauryl Sulfate 3 Heavy MetalsUSP Sodium Lauryl Sulfate 4 Sodium ChlorideUSP Sodium Lauryl Sulfate 5 Sodium SulfateUSP Sodium Lauryl Sulfate 6 AlkalinityUSP Sodium Lauryl Sulfate 7 Total AlcoholsUSP Sodium Lauryl Sulfate 8 Unsulfated AlcoholsUSP Sorbitol 1 Identification AUSP Sorbitol 2 Identification BUSP Sorbitol 3 AssayUSP Sorbitol 4 Residue on IgnitionUSP Sorbitol 5 Reducing SugarsUSP Sorbitol 6 ChlorideUSP Sorbitol 7 SulfateUSP Sorbitol 8 pHUSP Sorbitol 9 Water DeterminationUSP Sorbitol 10 Clarity and color of solutionUSP Sorbitol Solution 2 Identification BUSP Sorbitol Solution 3 Identification CUSP Sorbitol Solution 4 AssayUSP Sorbitol Solution 5 Residue on IgnitionUSP Sorbitol Solution 6 Reducing sugarsUSP Sorbitol Solution 7 pHUSP Sorbitol Solution 8 WaterUSP Soybean Oil 3 Heavy MetalsUSP Soybean Oil 4 Alkaline ImpuritiesUSP Soybean Oil 5 Acid ValueUSP Soybean Oil 6 Peroxide ValueUSP Soybean Oil 8 Unsaponifiable matterUSP Soybean Oil 9 WaterUSP Soybean Oil (Fatty acid composition) 1 Identification AUSP Soybean Oil (Fatty acid composition) 7 Fatty Acid CompositionUSP Soybean Oil (Fatty acid composition) 7 C16:1USP Soybean Oil (Fatty acid composition) 7 C18:3USP Soybean Oil (Fatty acid composition) 7 C20:1USP Soybean Oil (Fatty acid composition) 7 C22:1USP Soybean Oil (Fatty acid composition) 7 C14:0USP Soybean Oil (Fatty acid composition) 7 <C14:0USP Soybean Oil (Fatty acid composition) 7 C16:0USP Soybean Oil (Fatty acid composition) 7 C18:0USP Soybean Oil (Fatty acid composition) 7 C18:2USP Soybean Oil (Fatty acid composition) 7 C20:0USP Soybean Oil (Fatty acid composition) 7 C22:0USP Soybean Oil (Fatty acid composition) 7 C24:0USP Soybean Oil (Fatty acid composition) 7 C18:1

Limit of citrate, oxalate, phosphate, or tartrate

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 163 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

1 Infrared absorption

1 Ultraviolet absorptionUSP Spironolactone 1 AssayUSP Spironolactone 2 pHUSP Stannous Fluoride 2 Identification BUSP Stannous Fluoride 3 Identification CUSP Stannous Fluoride 4 pHUSP Stannous Fluoride 5 Loss on DryingUSP Stannous Fluoride 6 Water Insoluble substancesUSP Stannous Fluoride 7 AntimonyUSP Stannous Fluoride 8 FluorideUSP Sucralose 1 Identification AUSP Sucralose 3 Identification CUSP Sucralose 5 Residue on IgnitionUSP Sucralose 6 Heavy MetalsUSP Sucralose 8 Related compoundsUSP Sucralose 9 Limit of hydrolysis productsUSP Sucralose 10 Optical rotationUSP Sucralose 11 WaterUSP Sucralose (ID B and/or Assay) 2 Identification BUSP Sucralose (ID B and/or Assay) 4 AssayUSP Sucralose (Limit of Methanol) 7 Limit of MethanolUSP Sulfur Dioxide 1 Sulfur DioxideUSP Sulfuric Acid 1 Identification AUSP Sulfuric Acid 2 AssayUSP Sulfuric Acid 3 Residue on IgnitionUSP Sulfuric Acid 4 ChlorideUSP Sulfuric Acid 5 Heavy MetalsUSP Sulfuric Acid 6 Reducing SubstancesUSP Sulisobenzone 1 IdentificationUSP Sulisobenzone 2 WaterUSP Sulisobenzone 3 Assay (anhydrous basis)USP Taurine 1 Identification AUSP Taurine 2 Assay (Nitrogen Determination Method II)USP Taurine 3 Residue on IgnitionUSP Taurine 4 ChlorideUSP Taurine 5 SulfateUSP Taurine 6 IronUSP Taurine 7 Heavy MetalsUSP Taurine 8 Related compoundsUSP Taurine 8 Individual ImpuritiesUSP Taurine 9 Loss on DryingUSP Thiamine Hydrochloride 1 Identification AUSP Thiamine Hydrochloride 2 Identification BUSP Thiamine Hydrochloride 4 Residue on IgnitionUSP Thiamine Hydrochloride 5 Limit of nitrateUSP Thiamine Hydrochloride 7 pHUSP Thiamine Hydrochloride 8 Water DeterminationUSP Thiamine Hydrochloride 9 Absorbance of solution

3 Assay (anhydrous basis)

USP Spectrophotometric Indentification TestsUSP Spectrophotometric Indentification Tests

USP Thiamine Hydrochloride (Assay and/or Related compounds)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 164 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest Number

6 Related compoundsUSP Titanium Dioxide 1 Identification AUSP Titanium Dioxide 2 AssayUSP Titanium Dioxide 3 Loss on ignitionUSP Titanium Dioxide 4 Loss on DryingUSP Titanium Dioxide 5 Water-soluble substancesUSP Titanium Dioxide 6 Acid-soluble substancesUSP Tocopherols Excipient 1 Identification AUSP Tocopherols Excipient 4 Acidity

2 Identification B

3 Assay

3 beta plus gamma Tocopherols

3 delta-Tocopherol

3 alpha-Tocopherol

3 Total TocopherolsUSP Trehalose 1 Identification AUSP Trehalose 2 Identification BUSP Trehalose 3 Identification CUSP Trehalose 5 Residue on IgnitionUSP Trehalose 6 Heavy MetalsUSP Trehalose 8 Colour and Clarity of SolutionUSP Trehalose 9 Optical (Specific) RotationUSP Trehalose 10 pHUSP Trehalose 11 Water DeterminationUSP Trehalose 12 ChlorideUSP Trehalose 13 SulfateUSP Trehalose 14 Nitrogen ContentUSP Trehalose (Related substances) 4 AssayUSP Trehalose (Related substances) 7 Related SubstancesUSP Trehalose (Related substances) 7 Acceptance criteria - 1USP Trehalose (Related substances) 7 Acceptance criteria - 2USP Tribasic Calcium Phosphate 1 Identification AUSP Tribasic Calcium Phosphate 2 Identification BUSP Tribasic Calcium Phosphate 3 AssayUSP Tribasic Calcium Phosphate 4 ChlorideUSP Tribasic Calcium Phosphate 5 SulfateUSP Tribasic Calcium Phosphate 6 BariumUSP Tribasic Calcium Phosphate 7 Heavy MetalsUSP Tribasic Calcium Phosphate 8 Limit of fluorideUSP Tribasic Calcium Phosphate 9 Loss on IgnitionUSP Tribasic Sodium Phosphate 1 Identification A (Sodium)USP Tribasic Sodium Phosphate 2 Identification B (Phosphate)USP Tribasic Sodium Phosphate 3 AssayUSP Tribasic Sodium Phosphate 4 Loss on IgnitionUSP Tribasic Sodium Phosphate 5 Arsenic (ICP)USP Tribasic Sodium Phosphate 6 Lead (ICP)

USP Thiamine Hydrochloride (Assay and/or Related compounds)

USP Tocopherols Excipient (ID B and/or Assay)USP Tocopherols Excipient (ID B and/or Assay)USP Tocopherols Excipient (ID B and/or Assay)USP Tocopherols Excipient (ID B and/or Assay)USP Tocopherols Excipient (ID B and/or Assay)USP Tocopherols Excipient (ID B and/or Assay)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 165 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Tribasic Sodium Phosphate 7 Heavy Metals (ICP)

USP Tribasic Sodium Phosphate 8 Insoluble SubstancesUSP Trimethobenzamide Hydrochloride 1 Identification AUSP Trimethobenzamide Hydrochloride 2 Identification BUSP Trimethobenzamide Hydrochloride 3 Identification CUSP Trimethobenzamide Hydrochloride 4 Identification DUSP Trimethobenzamide Hydrochloride 5 Melting RangeUSP Trimethobenzamide Hydrochloride 6 Loss on DryingUSP Trimethobenzamide Hydrochloride 7 Residue on IgnitionUSP Trimethobenzamide Hydrochloride 8 Heavy MetalsUSP Trimethobenzamide Hydrochloride 9 AssayUSP Trolamine Salicylate 1 IdentificationUSP Trolamine Salicylate 3 pHUSP Trolamine Salicylate 4 Specific GravityUSP Trolamine Salicylate 5 Refractive indexUSP Trolamine Salicylate (Assay) 2 AssayUSP Tyrosine 1 Identification AUSP Tyrosine 2 Assay (anhydrous basis)USP Tyrosine 3 Residue on IgnitionUSP Tyrosine 4 ChlorideUSP Tyrosine 5 SulfateUSP Tyrosine 6 Heavy MetalsUSP Tyrosine 6 IronUSP Tyrosine 7 Related compoundsUSP Tyrosine 8 Optical (Specific) RotationUSP Tyrosine 9 Loss on DryingUSP Ubidecarenone 1 Identification AUSP Ubidecarenone 2 Identification BUSP Ubidecarenone 3 Assay (Anhydrous)USP Ubidecarenone 4 Residue on IgnitionUSP Ubidecarenone 5 Heavy MetalsUSP Ubidecarenone 6 Water DeterminationUSP Vitamin A 1 Identification AUSP Vitamin A 2 Identification B (Liquid)USP Vitamin A 2 Identification B (Solid)USP Vitamin A 3 Assay (Procedure 2)USP Vitamin A 3 Assay (Procedure 1)USP Vitamin A 4 Absorbance ratioUSP Vitamin E 1 Identification A (Tocopherol)USP Vitamin E 1 Identification A (Tocopheryl Acetate)USP Vitamin E 1USP Vitamin E 2 Identification B (Tocopherol)USP Vitamin E 2 Identification B (Tocopheryl Acetate)USP Vitamin E 2USP Vitamin E 3 Identification CUSP Vitamin E 4 Assay (Alpha Tocopherol)USP Vitamin E 4 Assay (Alpha Tocopheryl Acetate)USP Vitamin E 4 Assay (Alpha Tocopheryl Acid Succinate)USP Vitamin E 5 AcidityUSP Water Determination 1 WaterUSP Witch Hazel 1 Specific Gravity

Identification A (Tocopheryl Acid Succinate)

Identification B (Tocopheryl Acid Succinate)

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 166 of 181

Raw Material MonographsALS Pharmaceutical cannot perform

Monograph Name ANALYTETest NumberUSP Witch Hazel 2 pH

USP Witch Hazel 3 Nonvolatile ResidueUSP Witch Hazel 4 Limit of tanninsUSP Witch Hazel 5 Alcohol contentUSP Zinc Citrate 1 Identification AUSP Zinc Citrate 2 Identification BUSP Zinc Citrate 3 AssayUSP Zinc Citrate 4 ChlorideUSP Zinc Citrate 5 SulfateUSP Zinc Citrate 6 Lead USP Zinc Citrate 6 ArsenicUSP Zinc Citrate 6 CadmiumUSP Zinc Citrate 7 Loss on DryingUSP Zinc Gluconate 1 Identification AUSP Zinc Gluconate 2 Identification BUSP Zinc Gluconate 3 AssayUSP Zinc Gluconate 4 ChlorideUSP Zinc Gluconate 5 SulfateUSP Zinc Gluconate 6 Reducing SubstancesUSP Zinc Gluconate 7 pHUSP Zinc Gluconate 8 Water DeterminationUSP Zinc Oxide Neutral 1 Identification AUSP Zinc Oxide Neutral 2 Identification BUSP Zinc Oxide Neutral 3 AssayUSP Zinc Oxide Neutral 4 SulfateUSP Zinc Oxide Neutral 5 LeadUSP Zinc Oxide Neutral 6 Iron and other heavy metalsUSP Zinc Oxide Neutral 7 Magnesium OxideUSP Zinc Oxide Neutral 8 Loss on ignitionUSP Zinc Oxide Neutral 9 AlkalinityUSP Zinc Oxide Neutral 10 Carbonate and color of solution

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 167 of 181

Please search the list below for your desired analyte.Note: The list is not exhaustive and analytes are added regularly

In-house Method AnalytesACTIVE

1,2-Octanediol1,4-Dioxane

10-hydroxy-2-decenoic acid2-(4-butylphenyl)propionic acid

2-Butoxyethanol2-Chloroethanol( Ethylene Chlorhydrin)

2-Chlorotritanol2-methyl-1,3-propanediol

2-methyl-2-Butanol3-phenyl-1-propanol4-Aminobenzoic Acid

4-Aminophenol4-chloro-3,5 xylenol

4-Chloro-3-Methy Phenol4-Dimethylaminopyridine

4-MBC4-Methylbenzylidene Camphor

AbamectinAcepromazine Base

Acepromazine MaleateAcetaldehyde

Acetic AcidAcetic Anhydride

AcetoneAcetulan

Acetyl CarnitineAcetyl L-Carnitine Hydrochloride

Acetyl levocarnirine HClAciclovir

Acrylic AcidAdenosine triphosphate

ALA (Alpha Linolenic Acid)Alanine

AldehydesAllantoin

Allyl Isothiocyanatealpha- Lipoic Acidalpha-bisabolol

alpha-Cypermetherinalpha-Terpineol

AltrenogestAluminium

Aminobenzoic Acid, 4-Amitraz

If you cannot find what you need please email us and we may be able to help

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 168 of 181

In-house Method AnalytesACTIVE

Amlodipine Amlodipine BesylateAmlodipine Maleate

Ammonia BicarbonateAmoxicillin Trihydrate

AnetholeAnetholeAnise Oil

Aniseed OilAntipamezole HCl

ArginineArginine HCl

Arnica Flower Infused OilArsenic

Ascorbic Acid (HPLC)Ascorbic Acid (Titration)

Ascorbyl PalmitateAscorbyl Tetra Isopalmitate

AsparagineAtorvastatin

Atropine SulphateAvermectinAvobenzone

Bacosides-Total in BacopaBalsam (Peru)

Barboloin (Aloin)Beeswax Alcohols

Bemotrizinol (Tinosorb S)Benzaldehyde

Benzalkonium ChlorideBenzocaineBenzoic Acid

Benzophenone - 3Benzoyl Peroxide

Benzyl AlcoholBenzyl Benzoate

Benzyl Penicillin sodiumBetacarotene

Betamethasone AcetateBetamethasone Na Phosphate

BHTBiotin

BismuthBMBM (Butyl methoxy dibenzoylmethane)

BoronBromhexine HCl

Butanone

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 169 of 181

In-house Method AnalytesACTIVE

ButoxyethanolButyl Hydroxybenzoate,total

Butyl ParabenButylated Hydroxyanisole

CadmiumCaffeineCalcitriolCalcium

Calcium Ascorbate (HPLC)Calcium Ascorbate (Titration)

Calcium Ascorbate dihydrate (HPLC)Calcium Ascorbate dihydrate (Titration)

Calcium PantothenateCamphor

Camphor OilCaprylyl glycol

Carbamide PeroxideCarbimazole

Carnitine Carnitine Furmarate

Carotenoids TotalCarvacrolcastor oilCatechin

Cetalkonium ChlorideCetirizine Dihydrochloride

Cetyl AlcoholCetylpyridinium Chloride (CPC)

Chamomile OilChloramphenicol

Chlorhexidine DigluconateChlorhexidine HCl

Chloride Content or Total CholrideChlorocresol

Chlorogenic acidChlorphenesin

Chlorpheniramine MaleateChlorpyrifos

Cholecalciferol (Vitamin D3)Choline

Choline BitartrateCholine Salicylate

Chondroitin SulphateChondroitin Sulphate Sodium

Chondroitin-6-SulphateChromatographic Profile

Chromium

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 170 of 181

In-house Method AnalytesACTIVE

Chrysin / PropolisCineole

Citral Contentcitrate

Citric acidCitronella Content

Citronella OilClenbuterol HCl

ClorsulonClotrimazoleClove Bud Oil

Coal Tar SolutionCobalt

Codeine PhophateColloidal Oatmeal

CopperCoriander Oil

creatineCreatine monohydrate

CreosoteCresol

Curcumin in TumericCyanocobalaminCyclomethicone

Cyclomethicone-D3Cyclomethicone-D4Cyclomethicone-D5Cyclomethicone-D6

Cymene,-pCyromazine

CystineCythioate

d-alpha Tocopherol D-alpha Tocopheryl Acetate

d-alpha Tocopheryl Acid SuccinateDeltamethrin

Desmethyl malathionDetomidine HCl

Detomidine Impurity ADexamethasoneDHHBenzoate

DiadzinDiazolidinyl UreaDiBromoethane

DiBromomethane Diethylamine Hyroxybenzoyl Hexyl Benzoate

Diethylene Glycol

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 171 of 181

In-house Method AnalytesACTIVE

Diethylhexyl 2,6 naphthalateDihydroxyacetone (DHA)

Dill OilDill Seed Oil

DimenhydrinateDimethyl formamideDimethyl Sulfoxide

Dimethylglycine HClDimethylsulphone

Dimetridazole Di-n-Propylisoncinchomeronate (MGK 326)

Diphenhydramine, Related SubstancesDiphenyhydramine HCl

Disodium EdetateDL-alpha Tocopheryl Acetate,

DodecanolDoxycycline Hydrate

Doxylamine SuccinateD-Panthenol

D-riboseEconazole NitrateEHMCinnamate

EleuthoricideEleuthorsides B+E

EPAEpicatechin

Ergocalciferol (Vit D2)Estradiol

Etamiphylline CamsylateEthanol

Ethyl acetateEthyl Hexyl Triazone

Ethyl HydroxybenzoateEthyl Paraben

Ethylene ChlorhydrinEthylene GlycolEthylene OxideEucalyptus Oil

EugenolFat

Fatty Acid ProfileFatty Acids

Fenbendazole EmbonateFennel Oil

Fluconazole

Elemental Ananlysis using ICP-OES and ICP-MSMore actives listed in ANGEL than here

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 172 of 181

In-house Method AnalytesACTIVEFluoride

Folic AcidFolinic Acid

FormaldehydeFormic Acid

FructoseFumaric Acid

GenistinGentamicin Sulphate

Geranium OilGingerols

GinkgoflavonglycosidesGLA (Gamma Linolenic Acid)

GlucosamineGlucosamine HCl (Glucosamine Hydrochloride)

Glucosamine SulphateGlucosamine Sulphate NaCl (Glucosamine Sulphate Sodium Chloride)

Glucosamine Sulphate Potassium ChlorideGlucose

GlutamineGluteraldehyde

GlycerineGlycerolGlycine

Glycrrihizic AcidGuaiacol

Hederacoside CHeptaminol Hydrochloride

HesperidinHexamidine DiisethionateHexamidine isethionate

Hexanediol 1,2Histidine

HomosalateHydrocortisone

Hydrocortisone AcetateHydroquinone

Hydroxocobalamin AcetateHydroxycitric Acid

Hydroxycitric Acid calcium saltHydroxydecenoic Acid,-10

Hydrozine HClHypericine Ibuprofen

Imidazolidinyl ureaIodineIron

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 173 of 181

In-house Method AnalytesACTIVE

Iso CaffeineIsobutylacetophenone

IsobutylparabenIsoflavoneglycosides

IsoleucineIsopropanol (Isopropyl Alcohol)

Isopropyl MyristateIsopropyl Palmitate

Ivermectin Juniper OilKathon CG

Ketamine HCLKetoconazole

Lactate Lactate Pentahydrate

Lactic AcidLactoferrin

LactoseLavender OilL-CarnitineL-CysteineL-Cystine

LeadLemon Eucalyptus oil

Lemongrass OilLeucine

Levamisole HClLevocarnitine

Levocarnitine Tartrate (L-Carnitine L-Tartrate)Lignocaine

Lignocaine HClLimonene

LinalolLinoleic Acid

Linolenic AcidLinolenic Acid,gamma

Lipoic AcidLithiumLutein

LycopeneLysine HClLysine HClMagnesiumMalathion

Malathion Related SubstancesMaleic AcidMalic Acid

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 174 of 181

In-house Method AnalytesACTIVEMaltitol

ManganeseMarjoram Oil

Medetomidine Melaleuca Oil

MelatoninMenaquinone - 7 (Vitamin K2 MK7)

MentholMepyramine Maleate

MercuryMethanol

MethimazoleMethionine

MethocarbamolMethoprene

Methyl & Propyl parabensMethyl 4-hydroxybenzoate

Methyl ChavicolMethyl Hydroxybenzoate

Methyl Hydroxybenzoate (methyl paraben)Methyl Nonyl Ketone

Methyl ParabenMethyl PropanediolMethyl Salicyalte

Methylbenzylidene CamphorMethylisothiazolinone

Methylsulfonyl MethaneMetoclopromideMetronidazole

MGK 264MGK 326

MiconazoleMiconazole Nitrate

MolybdenumMonosulfiram

Myrrh OilN Acetyl Cysteine

N-(4-Aminobenzoyl)-L-glutamic acidN,N-Diethyl-meta-toluamide (DEET, diethyltoluamide)

NaltrexoneNaproxen

NaringeninNaringinNarirutin

n-butylparabenN-dodecyl-2-Pyrrolidone

Neo Hesperidin

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 175 of 181

In-house Method AnalytesACTIVE

Neo Hesperidin DihydrochalconeNeomycin Sulphate

NiacinamideNickel

NiclosamideNicotinamideNicotinic acid

Nipstat (total paraben)N-Octylbicycloheptene Dicarboxinmide (MGK264)

Nutmeg Oilo-Cresol

Octanediol Octanediol 1,2

OctocryleneOctopirox

Octyl dimethyl PABAOctyl Methoxycinnamate

Octyl SalicylateOctyl triazone

OctyldodecanolOleic AcidOleuropein

Omeprazole Oxalic acid

Oxantel EmbonateOxethacaine

OxybendazoleOxynex ST

OxytetracyclineOxytocin

PABAp-Aminobenzoic acid

Pantothenic AcidParabens

ParacetamolParaffin

Parsley OilParsol 1789Parsol MCX

Parthenolidep-Chloroaniline

p-CresolPentobarbitone Sodium

Peppermint OilPermethrin (25:75)

Phenobarbitone SodiumPhenol

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 176 of 181

In-house Method AnalytesACTIVE

PhenoxyethanolPhentolamine mesylate

PhenylalaninePhenylbenzimidazole Sulphonic Acid

PhenylbutazonePhenylephrine HCl

PhenylpropanolPhenytoin Sodium

PholcodinePhosphorus

Phytomenadione (Vitamin K1)Picaridin

PimobendanPine Oil

PiperazinePiperonyl Butoxide

PolicosanolPolycosanol (Sugar Cane Wax Alcohols)

Polyethylene GlycolPolyethylene Glycol 3350

Polymyxin B Polypropylene Glycol

PotassiumPotassium Iodide

Potassium SorbatePraziquantelPrednisolone

Proanthocyanidins (OPC)Procyanidin

ProgesteronePromethazine HCl

Propantheline BromidePropionic Acid

Propolis Propyl hyroxybenzoate (Propyl Paraben)

Propylene GlycolPteroic acid

PyrantelPyrantel Embonate (Pyrantel pamoate)

PyrethrinsPyridoxal-5-Phosphate

Pyridoxine Pyridoxine HCl

Pyridoxine-5-phosphateQuercetin

Quercetin DihydrateRanitidine HCL

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 177 of 181

In-house Method AnalytesACTIVERetinol

Retinyl AcetateRetinyl Palmitate

Retinyl PropionateRiboflavin

Riboflavin 5 PhospahteRosemary Oil

RubidiumRutin

S-Adenosylmethionine disulfate tosylate (SAMe)Safrole

Sage OilSalicin

Salicylic AcidSandalwood Oil

SassafrasSaw Palmetto

SeleniumSelenomethionine

Sennoside BSerenoa serrulata (as standard fatty acids)

SerineSesquiterpenic Acid (Valerian)

SilicaSilicon

Silybins-total like substancesSilymarin as Silybin (or as Silibinin)

S-MethopreneSodium

Sodium BenzoateSodium Bicarbonate

Sodium ChlorideSodium Fluoride

Sodium Lauryl SulphateSodium Methyl Hydroxybenzoate

Sodium PicosulphateSorbic Acid

sorbitolSqualene

St John's WortSucrose

SulphadiazineSulphadimidineSulphamerazine

SulphaquinoxalineSulphathiazole

Sweet Orange Oil

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 178 of 181

In-house Method AnalytesACTIVE

SynephrineTartaric Acid

TaurineTea Tree Oil

Terpentine OilTerpinolene (terpinene)

Tetra Bromo Ortho CresolTetrachlorvinphos

TheophylineThiamine HCl

Thiamine mononitrateThiamine Nitrate

ThiomersalThreonineThyme Oil

ThymolTin

Tinosorb MTinosorb STitanium

Titanium DioxideTOC

Tocopherol, d-alpha Tocopherol, DL-alphaTocopheryl Acetate

Tocopheryl Acetate, d-alpha Tocopheryl Acetate, DL-alpha

Tocopheryl Acid Succinate, d-alphaTolnaftate

Total alpha-Terpineol & Terpinolene contentTotal Bees wax alcohol

Total CatechinTotal citrate

Tramadol HydrochlorideTrans-Retinoic Acid

Triamcinolone AcetonideTriclosan

TrimethoprimTryptophan

Turpentine OilTyrosine

UbidecarenoneUrea

Uridine triphosphateUvinul A

Valerenic acidValine

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 179 of 181

In-house Method AnalytesACTIVEVanillin

Vitamin B'sVolatile Oils

Wintergreen OilXylazine HCl

XylitolYlang, Ylang Oil- Chromatographic Profile

zeaxanthinZinc

Zinc Oxide

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 180 of 181

Please search the list below for your desired analyte.Note: The list is not exhaustive and analytes are added regularly

Physical TestingTest Parameter

Appearance, Odour & Taste of Pharma ProductsAsh

ConductivitySpecific Gravity, Bulk Density, Density

DisintegrationDissolutionFriabilityHardnessLeakers

Length, Breadth, WidthLoss on Drying

Loss on Drying (Vacuum)Loss on Ignition @ 600°C

Loss on Ignition @ 900°C to 1000°CRefractive Index

Residue on Evaporation, Total SolidsResidue on Ignition

Sulphated AshSwelling index

Total SolidsTurbidity

Uniformity of Dosage units (mass variation)Uniformity of Fill weight

Uniformity of WeightViscosity

Weight lossAcid Value

Acidity / AlkalinityMoisture by Karl Fischer (water)

Peroxide ValuepH

Nitrogen (Protein)

If you cannot find what you need please email us and we may be able to help

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005387ALS Pharmaceutical Method IndexNSW: 10/2-8 South Street, Rydalmere NSW 2116 (02 8832 7500)

VIC: 22 Dalmore Drive, Scoresby VIC 3179 (03 8756 8111)E: [email protected]

005387Updated on: 08-July-2015 005387Page 181 of 181

Please search the list below for your desired analyte.Note: The list is not exhaustive and analytes are added regularly

Microbial Limits TestingTest Parameter

Total Aerobic Microbial Count - EnumerationTotal Aerobic Microbial Count - Filtration

Total Yeast and Mould CountBile Tolerant Gram Negative Bacteria

SalmonellaE. coli

Staphylococcus aureusCandida albicans

ClostridiaColiforms

EnterobacteriaceaePseudomonads

Pseudomonas aeruginosa

Other Microbiological ServicesTest Parameter

Bioburden (Bacteria, Yeast, Mould)Biological Indicator Enumeration (Spore Strip)

Endotoxin (LAL)Organism Identification

Preservative Efficacy - BP and USPProbiotic Enumeration

If you cannot find what you need please email us and we may be able to help