numerics 2.2.5. relative density25 6.5 6.1-3313 2.2.6 ... pharmacopoeia 6.6 index numerics 1....

EUROPEAN PHARMACOPOEIA 6.6 Index

Numerics1. General notices .............................................................6.5-47592.1.1. Droppers ..............................................................................152.1.2. Comparative table of porosity of sintered-glassfilters..............................................................................................15

2.1.3. Ultraviolet ray lamps for analytical purposes..............152.1.4. Sieves ...................................................................................162.1.5. Tubes for comparative tests ............................................172.1.6. Gas detector tubes.............................................................172.1. Apparatus ...............................................................................152.2.10. Viscosity - Rotating viscometer method .................... 282.2.11. Distillation range ............................................................ 302.2.12. Boiling point ....................................................................312.2.13. Determination of water by distillation........................312.2.14. Melting point - capillary method................................. 322.2.15. Melting point - open capillary method ...................... 322.2.16. Melting point - instantaneous method ...................... 332.2.17. Drop point ........................................................................ 332.2.18. Freezing point................................................................. 352.2.19. Amperometric titration ................................................. 352.2.1. Clarity and degree of opalescence of liquids...............212.2.20. Potentiometric titration ................................................ 352.2.21. Fluorimetry...................................................................... 362.2.22. Atomic emission spectrometry.................................... 362.2.23. Atomic absorption spectrometry ................................ 372.2.24. Absorption spectrophotometry, infrared .................. 392.2.25. Absorption spectrophotometry, ultraviolet andvisible.............................................................................................41

2.2.26. Paper chromatography ................................................. 432.2.27. Thin-layer chromatography .......................................... 432.2.28. Gas chromatography ..................................................... 452.2.29. Liquid chromatography ................................................ 462.2.2. Degree of coloration of liquids...................................... 222.2.30. Size-exclusion chromatography .................................. 472.2.31. Electrophoresis (5.8.)..........................................6.6-51432.2.31. Electrophoresis ....................................................6.6-50412.2.32. Loss on drying ................................................................ 532.2.33. Nuclear magnetic resonance spectrometry ...6.3-39092.2.34. Thermal analysis..................................................6.1-33112.2.35. Osmolality ........................................................................ 572.2.36. Potentiometric determination of ionicconcentration using ion-selective electrodes....................... 58

2.2.37. X-ray fluorescence spectrometry................................. 592.2.38. Conductivity .................................................................... 592.2.39. Molecular mass distribution in dextrans .................. 602.2.3. Potentiometric determination of pH............................ 242.2.40. Near-infrared spectrophotometry ............................... 622.2.41. Circular dichroism.......................................................... 662.2.42. Density of solids ..................................................6.6-50462.2.43. Mass spectrometry ......................................................... 682.2.44. Total organic carbon in water for pharmaceuticaluse..................................................................................................71

2.2.45. Supercritical fluid chromatography............................712.2.46. Chromatographic separation techniques.......6.4-44072.2.47. Capillary electrophoresis (5.8.).........................6.6-51432.2.47. Capillary electrophoresis ...................................6.6-50472.2.48. Raman spectrometry ..................................................... 822.2.49. Falling ball viscometer method................................... 842.2.4. Relationship between reaction of solution,approximate pH and colour of certain indicators .............. 25

2.2.54. Isoelectric focusing (5.8.) ..................................6.6-51432.2.54. Isoelectric focusing.............................................6.6-50522.2.55. Peptide mapping (5.8.) .......................................6.6-51432.2.55. Peptide mapping..................................................6.6-50542.2.56. Amino acid analysis (5.8.)..................................6.6-51442.2.56. Amino acid analysis ............................................6.6-50572.2.57. Inductively coupled plasma-atomic emissionspectrometry ............................................................................... 96

2.2.58. Inductively coupled plasma-mass spectrometry ...... 98

2.2.5. Relative density................................................................. 252.2.60. Melting point - instrumental method..............6.1-33132.2.6. Refractive index ................................................................ 262.2.7. Optical rotation ................................................................. 262.2.8. Viscosity.............................................................................. 272.2.9. Capillary viscometer method ......................................... 272.2. Physical and physicochemical methods...........................212.3.1. Identification reactions of ions and functionalgroups ........................................................................................ 103

2.3.2. Identification of fatty oils by thin-layerchromatography..............................................................6.6-5067

2.3.3. Identification of phenothiazines by thin-layerchromatography....................................................................... 107

2.3.4. Odour ................................................................................ 1072.3. Identification....................................................................... 1032.4.10. Lead in sugars............................................................... 1152.4.11. Phosphates......................................................................1162.4.12. Potassium........................................................................1162.4.13. Sulphates ........................................................................1162.4.14. Sulphated ash ................................................................1162.4.15. Nickel in polyols ............................................................1162.4.16. Total ash..........................................................................1162.4.17. Aluminium.......................................................................1172.4.18. Free formaldehyde ........................................................1172.4.19. Alkaline impurities in fatty oils ..................................1172.4.1. Ammonium........................................................................1112.4.21. Foreign oils in fatty oils by thin-layerchromatography........................................................................117

2.4.22. Composition of fatty acids by gas chromato-graphy ...............................................................................6.6-5071

2.4.23. Sterols in fatty oils ....................................................... 1202.4.24. Identification and control of residual solvents...... 1212.4.25. Ethylene oxide and dioxan......................................... 1262.4.26. N,N-Dimethylaniline .................................................... 1272.4.27. Heavy metals in herbal drugs and fatty oils ........... 1282.4.28. 2-Ethylhexanoic acid ................................................... 1292.4.29. Composition of fatty acids in oils rich in omega-3acids...................................................................................6.6-5073

2.4.2. Arsenic ...............................................................................1112.4.30. Ethylene glycol and diethylene glycol in ethoxylatedsubstances ..................................................................................131

2.4.31. Nickel in hydrogenated vegetable oils ......................1312.4.32. Total cholesterol in oils rich in omega-3 acids ...... 1322.4.3. Calcium..............................................................................1112.4.4. Chlorides .......................................................................... 1122.4.5. Fluorides .......................................................................... 1122.4.6. Magnesium....................................................................... 1122.4.7. Magnesium and alkaline-earth metals ....................... 1122.4.8. Heavy metals ................................................................... 1122.4.9. Iron .................................................................................... 1152.4. Limit tests .............................................................................1112.5.10. Oxygen-flask method................................................... 1402.5.11. Complexometric titrations.......................................... 1402.5.12. Water : semi-micro determination ..............................1412.5.13. Aluminium in adsorbed vaccines...............................1412.5.14. Calcium in adsorbed vaccines ................................... 1422.5.15. Phenol in immunosera and vaccines ....................... 1422.5.16. Protein in polysaccharide vaccines .......................... 1422.5.17. Nucleic acids in polysaccharide vaccines ................ 1422.5.18. Phosphorus in polysaccharide vaccines.................. 1422.5.19. O-Acetyl in polysaccharide vaccines......................... 1432.5.1. Acid value......................................................................... 1372.5.20. Hexosamines in polysaccharide vaccines................ 1432.5.21. Methylpentoses in polysaccharide vaccines ........... 1432.5.22. Uronic acids in polysaccharide vaccines ................. 1442.5.23. Sialic acid in polysaccharide vaccines ..................... 1442.5.24. Carbon dioxide in gases.....................................6.3-39152.5.25. Carbon monoxide in gases................................6.3-3915

General Notices (1) apply to all monographs and other texts 5365

Index EUROPEAN PHARMACOPOEIA 6.6

2.5.26. Nitrogen monoxide and nitrogen dioxide ingases ........................................................................................... 146

2.5.27. Oxygen in gases ...................................................6.3-39162.5.28. Water in gases............................................................... 1462.5.29. Sulphur dioxide ............................................................ 1462.5.2. Ester value ....................................................................... 1372.5.30. Oxidising substances................................................... 1472.5.31. Ribose in polysaccharide vaccines............................ 1472.5.32. Water : micro determination ...................................... 1472.5.33. Total protein.................................................................. 1482.5.34. Acetic acid in synthetic peptides .............................. 1512.5.35. Nitrous oxide in gases ................................................. 1522.5.36. Anisidine value ............................................................. 1522.5.3. Hydroxyl value ................................................................ 1372.5.4. Iodine value ..................................................................... 1372.5.5. Peroxide value................................................................. 1382.5.6. Saponification value ...................................................... 1392.5.7. Unsaponifiable matter ................................................... 1392.5.8. Determination of primary aromaticamino-nitrogen ......................................................................... 139

2.5.9. Determination of nitrogen by sulphuric aciddigestion .................................................................................... 139

2.5. Assays ................................................................................... 1372.6.10. Histamine ....................................................................... 1652.6.11. Depressor substances.................................................. 1662.6.12. Microbiological examination of non-sterile products :microbial enumeration tests ........................................6.5-4769

2.6.13. Microbiological examination of non-sterile products :test for specified micro-organisms ..............................6.5-4773

2.6.14. Bacterial endotoxins ...........................................6.6-50772.6.15. Prekallikrein activator................................................. 1892.6.16. Tests for extraneous agents in viral vaccines forhuman use................................................................................. 190

2.6.17. Test for anticomplementary activity ofimmunoglobulin..............................................................6.6-5081

2.6.18. Test for neurovirulence of live virus vaccines........ 1932.6.19. Test for neurovirulence of poliomyelitis vaccine(oral) ........................................................................................... 193

2.6.1. Sterility ....................................................................6.3-39192.6.20. Anti-A and anti-B haemagglutinins(indirect method) ..................................................................... 195

2.6.21. Nucleic acid amplification techniques ..................... 1952.6.22. Activated coagulation factors .................................... 1982.6.24. Avian viral vaccines : tests for extraneous agents inseed lots ............................................................................6.5-4778

2.6.25. Avian live virus vaccines : tests for extraneous agentsin batches of finished product .............................................. 202

2.6.26. Test for anti-D antibodies in human immunoglobulinfor intravenous administration ....................................6.5-4781

2.6.27. Microbiological control of cellular products .......... 2052.6.2. Mycobacteria ................................................................... 1592.6.7. Mycoplasmas...........................................................6.1-33172.6.8. Pyrogens........................................................................... 1642.6.9. Abnormal toxicity ........................................................... 1652.6. Biological tests ................................................................... 1552.7.10. Assay of human coagulation factor VII ................... 2282.7.11. Assay of human coagulation factor IX ..................... 2292.7.12. Assay of heparin in coagulation factors .................. 2302.7.13. Assay of human anti-D immunoglobulin................. 2302.7.14. Assay of hepatitis A vaccine ....................................... 2322.7.15. Assay of hepatitis B vaccine (rDNA)......................... 2332.7.16. Assay of pertussis vaccine (acellular)....................... 2332.7.17. Assay of human antithrombin III .............................. 2342.7.18. Assay of human coagulation factor II ...................... 2342.7.19. Assay of human coagulation factor X ...................... 2352.7.19. Assay of human coagulation factor X (2.7.19.)....... 2352.7.1. Immunochemical methods ........................................... 2092.7.20. In vivo assay of poliomyelitis vaccine(inactivated) .............................................................................. 235

2.7.21. Assay of human von Willebrand factor.................... 2372.7.22. Assay of human coagulation factor XI..................... 2382.7.23. Numeration of CD34/CD45+ cells inhaematopoietic products........................................................ 238

2.7.24. Flow cytometry ............................................................. 2402.7.25. Assay of human plasmin inhibitor ...................6.5-47862.7.27. Flocculation value (Lf) of diphtheria and tetanustoxins and toxoids (Ramon assay)........................................ 241

2.7.28. Colony-forming cell assay for humanhaematopoietic progenitor cells ........................................... 242

2.7.29. Nucleated cell count and viability............................. 2432.7.2. Microbiological assay of antibiotics...................6.3-39352.7.30. Assay of human protein C .................................6.2-36312.7.31. Assay of human protein S..................................6.2-36322.7.32. Assay of human α-1-proteinase inhibitor .......6.2-36332.7.4. Assay of human coagulation factor VIII .....................2162.7.5. Assay of heparin...............................................................2172.7.6. Assay of diphtheria vaccine (adsorbed) ......................2172.7.7. Assay of pertussis vaccine............................................. 2222.7.8. Assay of tetanus vaccine (adsorbed)........................... 2232.7.9. Test for Fc function of immunoglobulin ..........6.5-47852.7. Biological assays ................................................................ 2092.8.10. Solubility in alcohol of essential oils ....................... 2502.8.11. Assay of 1,8-cineole in essential oils ........................ 2502.8.12. Determination of essential oils in herbal drugs .... 2512.8.13. Pesticide residues................................................6.2-36372.8.14. Determination of tannins in herbal drugs .............. 2552.8.15. Bitterness value ............................................................ 2552.8.16. Dry residue of extracts................................................ 2562.8.17. Loss on drying of extracts .......................................... 2562.8.18. Determination of aflatoxin B1 in herbal drugs ...... 2562.8.1. Ash insoluble in hydrochloric acid ............................. 2492.8.20. Herbal drugs : sampling and sample preparation.. 2582.8.22. Determination of ochratoxin A in herbaldrugs..................................................................................6.6-5087

2.8.2. Foreign matter ................................................................ 2492.8.3. Stomata and stomatal index ........................................ 2492.8.4. Swelling index................................................................. 2492.8.5. Water in essential oils.................................................... 2492.8.6. Foreign esters in essential oils .................................... 2502.8.7. Fatty oils and resinified essential oils in essentialoils............................................................................................... 250

2.8.8. Odour and taste of essential oils................................. 2502.8.9. Residue on evaporation of essential oils ................... 2502.8. Methods in pharmacognosy ............................................ 2492.9.10. Ethanol content and alcoholimetric tables ............ 2812.9.11. Test for methanol and 2-propanol ............................ 2822.9.12. Sieve test ........................................................................ 2832.9.14. Specific surface area by air permeability ................ 2832.9.16. Flowability...................................................................... 2862.9.17. Test for extractable volume of parenteralpreparations.............................................................................. 287

2.9.18. Preparations for inhalation : aerodynamic assessmentof fine particles ........................................................................ 287

2.9.19. Particulate contamination : sub-visible particles ... 3002.9.1. Disintegration of tablets and capsules..............6.3-39432.9.20. Particulate contamination : visible particles .......... 3022.9.22. Softening time determination of lipophilicsuppositories............................................................................. 302

2.9.23. Gas pycnometric density of solids ...................6.2-36422.9.25. Dissolution test for medicated chewing gums....... 3042.9.26. Specific surface area by gas adsorption(5.8.)...................................................................................6.6-5144

2.9.26. Specific surface area by gas adsorption.........6.6-51002.9.27. Uniformity of mass of delivered doses from multidosecontainers.................................................................................. 309

2.9.29. Intrinsic dissolution..................................................... 3092.9.2. Disintegration of suppositories and pessaries ......... 265

5366 See the information section on general monographs (cover pages)


2.9.31. Particle size analysis by laser lightdiffraction .........................................................................6.6-5103

2.9.32. Porosity and pore-size distribution of solids bymercury porosimetry .....................................................6.2-3643

2.9.33. Characterisation of crystalline and partially crystallinesolids by X-ray powder diffraction (XRPD)................6.3-3945

2.9.34. Bulk density and tapped density of powders ..6.5-47892.9.35. Powder fineness ..................................................6.2-36482.9.36. Powder flow (5.8.) ...............................................6.6-51442.9.36. Powder flow..........................................................6.6-51072.9.37. Optical microscopy (5.8.) ...................................6.6-51442.9.37. Optical microscopy..............................................6.6-51102.9.38. Particle-size distribution estimation by analyticalsieving (5.8.).....................................................................6.6-5145

2.9.38. Particle-size distribution estimation by analyticalsieving ...............................................................................6.6-5112

2.9.3. Dissolution test for solid dosage forms ............6.6-50912.9.40. Uniformity of dosage units................................6.1-33252.9.41. Friability of granules and spheroids ........................ 3302.9.42. Dissolution test for lipophilic solid dosage forms.. 3322.9.43. Apparent dissolution ..........................................6.1-33272.9.45. Wettability of porous solids includingpowders.............................................................................6.5-4791

2.9.4. Dissolution test for transdermal patches .................. 2752.9.5. Uniformity of mass of single-dose preparations....... 2782.9.6. Uniformity of content of single-dose preparations.. 2782.9.7. Friability of uncoated tablets (5.8.)....................6.6-51442.9.7. Friability of uncoated tablets ..............................6.6-51002.9.8. Resistance to crushing of tablets................................ 2792.9.9. Measurement of consistency by penetrometry ........6.2-3641

2.9. Pharmaceutical technical procedures ........................... 2633.1.10. Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions ...... 360

3.1.11. Materials based on non-plasticised poly(vinylchloride) for containers for dry dosage forms for oraladministration .................................................................6.4-4417

3.1.1.1. Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components....... 339

3.1.1.2. Materials based on plasticised poly(vinyl chloride)for tubing used in sets for the transfusion of blood andblood components ................................................................... 342

3.1.13. Plastic additives ...................................................6.2-36553.1.14. Materials based on plasticised poly(vinyl chloride)for containers for aqueous solutions for intravenousinfusion ...................................................................................... 366

3.1.15. Polyethylene terephthalate for containers forpreparations not for parenteral use..................................... 369

3.1.1. Materials for containers for human blood and bloodcomponents............................................................................... 339

3.1.3. Polyolefines...................................................................... 3443.1.4. Polyethylene without additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 348

3.1.5. Polyethylene with additives for containersfor parenteral preparations and for ophthalmicpreparations .............................................................................. 349

3.1.6. Polypropylene for containers and closures forparenteral preparations and ophthalmic preparations ... 352

3.1.7. Poly(ethylene - vinyl acetate) for containers and tubingfor total parenteral nutrition preparations ........................ 356

3.1.8. Silicone oil used as a lubricant ................................... 3583.1.9. Silicone elastomer for closures and tubing .............. 3583.1. Materials used for the manufacture of containers ..... 3393.2.1. Glass containers for pharmaceutical use ......... 6.6-51173.2.2.1. Plastic containers for aqueous solutions forinfusion ...................................................................................... 379

3.2.2. Plastic containers and closures for pharmaceuticaluse............................................................................................... 378

3.2.3. Sterile plastic containers for human blood andblood components ................................................................... 379

3.2.4. Empty sterile containers of plasticised poly(vinylchloride) for human blood and blood components.......... 381

3.2.5. Sterile containers of plasticised poly(vinyl chloride) forhuman blood containing anticoagulant solution ............. 382

3.2.6. Sets for the transfusion of blood and bloodcomponents............................................................................... 383

3.2.8. Sterile single-use plastic syringes ............................... 3843.2.9. Rubber closures for containers for aqueousparenteral preparations, for powders and forfreeze-dried powders ............................................................... 386

3.2. Containers ........................................................................... 3734.1.1. Reagents ..................................................................6.4-44214.1.1. Reagents ..................................................................6.5-47974.1.1. Reagents ..................................................................6.6-51254.1.2. Standard solutions for limit tests.......................6.4-45354.1.3. Buffer solutions .....................................................6.4-45404.1.3. Buffer solutions .....................................................6.6-51254.1. Reagents, standard solutions, buffer solutions ..6.4-44214.2.1. Primary standards for volumetric solutions....6.4-45454.2.2. Volumetric solutions.............................................6.4-45464.2. Volumetric analysis...................................................6.4-45454-Aminobenzoic acid ............................................................... 11644. Reagents.........................................................................6.4-44215.10. Control of impurities in substances for pharmaceuticaluse......................................................................................6.5-4805

5.1.10. Guidelines for using the test for bacterialendotoxins ........................................................................6.6-5130

5.11. Characters section in monographs .............................. 6595.1.1. Methods of preparation of sterile products .............. 5255.1.2. Biological indicators of sterilisation........................... 5275.12. Reference standards........................................................ 6635.1.3. Efficacy of antimicrobial preservation ..............6.6-51295.14. Gene transfer medicinal products for humanuse......................................................................................6.6-5149

5.1.4. Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceuticaluse......................................................................................6.3-3957

5.1.5. Application of the F0 concept to steam sterilisation ofaqueous preparations ....................................................6.3-3958

5.15. Functionality-related characteristics ofexcipients..........................................................................6.1-3339

5.1.6. Alternative methods for control of microbiologicalquality......................................................................................... 532

5.1.7. Viral safety........................................................................ 5435.1.9. Guidelines for using the test for sterility .........6.3-39585.1. General texts on microbiology ........................................ 5255.2.1. Terminology used in monographs on biologicalproducts ..................................................................................... 547

5.2.2. Chicken flocks free from specified pathogens for theproduction and quality control of vaccines...............6.6-5137

5.2.3. Cell substrates for the production of vaccines forhuman use........................................................................6.3-3963

5.2.4. Cell cultures for the production of veterinaryvaccines...................................................................................... 553

5.2.5. Substances of animal origin for the production ofimmunological veterinary medicinal products.........6.5-4801

5.2.6. Evaluation of safety of veterinary vaccines andimmunosera ............................................................................. 556

5.2.7. Evaluation of efficacy of veterinary vaccines andimmunosera .....................................................................6.1-3335

5.2.8. Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts ..................................................................................... 558

5.2.9. Evaluation of safety of each batch of veterinaryvaccines and immunosera...................................................... 567

5.2. General texts on biological products............................. 547



5.3. Statistical analysis of results of biological assays andtests............................................................................................. 571

5.4. Residual solvents ............................................................... 6035.5. Alcoholimetric tables ........................................................ 6135.6. Assay of interferons........................................................... 6275.7. Table of physical characteristics of radionuclidesmentioned in the European Pharmacopoeia..................... 633

5.8. Amino acid analysis (2.2.56)...................................6.6-51445.8. Capillary electrophoresis (2.2.47) .........................6.6-51435.8. Electrophoresis (2.2.31)...........................................6.6-51435.8. Friability of uncoated tablets (2.9.7) ....................6.6-51445.8. Isoelectric focusing (2.2.54) ...................................6.6-51435.8. Optical microscopy (2.9.37) ....................................6.6-51445.8. Particle-size distribution estimation by analytical sieving(2.9.38) ..............................................................................6.6-5145

5.8. Peptide mapping (2.2.55) ........................................6.6-51435.8. Pharmacopoeial harmonisation ............................6.6-51435.8. Powder flow (2.9.36) ................................................6.6-51445.8. Specific surface area by gas adsorption (2.9.26) ..6.6-51445.9. Polymorphism..................................................................... 649

AAbbreviations and symbols (1.) ......................................6.5-4759Abnormal toxicity (2.6.9.)......................................................... 165Absorption spectrophotometry, infrared (2.2.24.) ................ 39Absorption spectrophotometry, ultraviolet and visible(2.2.25.) .........................................................................................41

Acacia...................................................................................6.3-4013Acacia, spray-dried ............................................................6.3-4014Acamprosate calcium ..............................................................1088Acarbose.....................................................................................1089Acebutolol hydrochloride....................................................... 1091Aceclofenac.........................................................................6.5-4831Acemetacin .........................................................................6.3-4015Acesulfame potassium ............................................................1095Acetazolamide....................................................................6.4-4571Acetic acid, glacial ...................................................................1097Acetic acid in synthetic peptides (2.5.34.) ............................ 151Acetone.......................................................................................1098Acetylcholine chloride ............................................................1099Acetylcysteine ........................................................................... 1100β-Acetyldigoxin ..........................................................................1101Acetylsalicylic acid ................................................................... 1103Acetyltryptophan, N- ........................................................6.3-4016Acetyltyrosine, N- ..................................................................... 1106Aciclovir ..................................................................................... 1107Acid value (2.5.1.)....................................................................... 137Acitretin...................................................................................... 1109Actinobacillosis vaccine (inactivated), porcine .................... 943Activated charcoal.............................................................6.3-4088Activated coagulation factors (2.6.22.).................................. 198Adapalene ...........................................................................6.6-5193Additives, plastic (3.1.13.)................................................6.2-3655Adenine ...................................................................................... 1110Adeno-associated-virus vectors for human use ..........6.6-5159Adenosine ...........................................................................6.3-4018Adenovirus vectors for human use ...............................6.6-5152Adipic acid ................................................................................. 1113Adrenaline ..........................................................................6.2-3686Adrenaline tartrate ...................................................................1114Adsorption, gas, specific surface area by (2.9.26)(5.8.)...................................................................................6.6-5144

Adsorption, gas, specific surface area by (2.9.26.).....6.6-5100Aerodynamic assessment of fine particles in preparations forinhalation (2.9.18.) .................................................................. 287

Aflatoxin B1 in herbal drugs, determination of (2.8.18.) ... 256Agar......................................................................................6.3-4019Agnus castus fruit.............................................................6.2-3688Agrimony ....................................................................................1117

Air, medicinal .....................................................................6.3-4020Air, synthetic medicinal .......................................................... 1121Alanine ....................................................................................... 1121Albendazole............................................................................... 1122Albumin solution, human................................................6.6-5263Alchemilla .................................................................................. 1123Alcoholimetric tables (2.9.10.) ................................................ 281Alcoholimetric tables (5.5.) ...................................................... 613Alcuronium chloride................................................................ 1124Alendronate sodium .........................................................6.3-4296Alexandrian senna pods .........................................................2870Alfacalcidol ................................................................................ 1126Alfadex........................................................................................ 1127Alfentanil hydrochloride......................................................... 1128Alfuzosin hydrochloride ..................................................6.1-3394Alginic acid .........................................................................6.3-4022Alkaline-earth metals and magnesium (2.4.7.) .................... 112Alkaline impurities in fatty oils (2.4.19.)................................117Allantoin..................................................................................... 1131Allergen products..............................................................6.6-5165Allopurinol................................................................................. 1132all-rac-α-Tocopherol.................................................................3086all-rac-α-Tocopheryl acetate ..................................................3089Almagate .............................................................................6.3-4023Almond oil, refined ...........................................................6.6-5194Almond oil, virgin .............................................................6.6-5195Aloes, Barbados........................................................................ 1137Aloes, Cape ................................................................................ 1138Aloes dry extract, standardised......................................6.2-3690Alphacyclodextrin .................................................................... 1127Alprazolam ................................................................................ 1139Alprenolol hydrochloride ........................................................1141Alprostadil ................................................................................. 1143Alteplase for injection ............................................................. 1145Alternative methods for control of microbiological quality(5.1.6.)......................................................................................... 532

Altizide ................................................................................6.2-3691Alum............................................................................................ 1149Aluminium (2.4.17.) ....................................................................117Aluminium chloride hexahydrate ......................................... 1149Aluminium hydroxide, hydrated, for adsorption........6.1-3395Aluminium in adsorbed vaccines (2.5.13.).............................141Aluminium magnesium silicate......................................6.3-4024Aluminium oxide, hydrated.............................................6.3-4025Aluminium phosphate gel ...............................................6.3-4026Aluminium phosphate, hydrated .......................................... 1153Aluminium sodium silicate .............................................6.3-4026Aluminium sulphate ................................................................ 1154Alverine citrate ......................................................................... 1154Amantadine hydrochloride .............................................6.5-4832Ambroxol hydrochloride......................................................... 1156Amfetamine sulphate .............................................................. 1158Amidotrizoic acid dihydrate................................................... 1158Amikacin .............................................................................6.6-5195Amikacin sulphate ............................................................6.6-5197Amiloride hydrochloride......................................................... 1163Amino acid analysis (2.2.56) (5.8.) ................................6.6-5144Amino acid analysis (2.2.56.) ..........................................6.6-5057Aminobenzoic acid, 4- ............................................................. 1164Aminocaproic acid ................................................................... 1166Aminoglutethimide.................................................................. 1167Amiodarone hydrochloride .............................................6.3-4028Amisulpride ............................................................................... 1170Amitriptyline hydrochloride ...........................................6.3-4029Amlodipine besilate ..........................................................6.4-4572Ammonia (13N) injection ........................................................... 981Ammonia solution, concentrated ......................................... 1175Ammonio methacrylate copolymer (type A) ...................... 1175Ammonio methacrylate copolymer (type B) .......................1176



Ammonium (2.4.1.) .....................................................................111Ammonium bromide................................................................ 1177Ammonium chloride................................................................ 1178Ammonium glycyrrhizate....................................................... 1179Ammonium hydrogen carbonate .......................................... 1180Amobarbital............................................................................... 1180Amobarbital sodium ................................................................ 1181Amoxicillin sodium .................................................................. 1182Amoxicillin trihydrate ............................................................. 1184Amperometric titration (2.2.19.) ............................................... 35Amphotericin B .................................................................6.6-5198Ampicillin, anhydrous ............................................................ 1188Ampicillin sodium .................................................................... 1190Ampicillin trihydrate ............................................................... 1193Anaemia vaccine (live), chicken, infectious .................6.5-4817Anaesthetic ether .....................................................................1834Analysis, thermal (2.2.34.)...............................................6.1-3311Analytical sieving, particle-size distribution estimation by(2.9.38) (5.8.)....................................................................6.6-5145

Analytical sieving, particle-size distribution estimation by(2.9.38.) .............................................................................6.6-5112

Angelica root............................................................................. 1196Animal anti-T lymphocyte immunoglobulin for humanuse.............................................................................................1203

Animal immunosera for human use....................................... 685Animal spongiform encephalopathies, products with risk oftransmitting agents of............................................................. 694

Animal spongiform encephalopathy agents, minimising therisk of transmitting via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 558

Aniseed....................................................................................... 1199Anise oil...................................................................................... 1197Anisidine value (2.5.36.) ........................................................... 152Antazoline hydrochloride....................................................... 1199Anthrax spore vaccine (live) for veterinary use................... 859Anthrax vaccine for human use (adsorbed, prepared fromculture filtrates) ....................................................................... 757

Anti-A and anti-B haemagglutinins (indirect method)(2.6.20.) ...................................................................................... 195

Antibiotics, microbiological assay of (2.7.2.) ...............6.3-3935Antibodies (anti-D) in human immunoglobulin forintravenous administration, test for (2.6.26.) ...........6.5-4781

Antibodies for human use, monoclonal ................................ 690Anticoagulant and preservative solutions for human blood...................................................................................................1200

Anticomplementary activity of immunoglobulin(2.6.17.)..............................................................................6.6-5081

Anti-D antibodies in human immunoglobulin for intravenousadministration, test for (2.6.26.) ..................................6.5-4781

Anti-D immunoglobulin for intravenous administration,human ......................................................................................2059

Anti-D immunoglobulin, human ....................................6.2-3757Anti-D immunoglobulin, human, assay of (2.7.13.)............. 230Antimicrobial preservation, efficacy of (5.1.3.) ...........6.6-5129Antiserum, European viper venom ........................................ 970Antithrombin III concentrate, human .................................2060Antithrombin III, human, assay of (2.7.17.) .......................... 234Anti-T lymphocyte immunoglobulin for human use,animal.......................................................................................1203

Apomorphine hydrochloride .................................................1207Apparatus (2.1.) .............................................................................15Apparent dissolution (2.9.43.) ........................................6.1-3327Application of the F0 concept to steam sterilisation ofaqueous preparations (5.1.5.).......................................6.3-3958

Aprotinin .............................................................................6.3-4033Aprotinin concentrated solution....................................6.3-4035Arachis oil, hydrogenated ...............................................6.2-3694Arachis oil, refined............................................................6.6-5200Arginine...................................................................................... 1212

Arginine aspartate ................................................................... 1213Arginine hydrochloride........................................................... 1214Arnica flower......................................................................6.3-4038Arnica tincture...................................................................6.3-4040Arsenic (2.4.2.) .............................................................................111Arsenious trioxide for homoeopathic preparations..........1073Articaine hydrochloride.......................................................... 1217Artichoke leaf.....................................................................6.6-5201Artichoke leaf dry extract ...............................................6.6-5202Ascorbic acid ......................................................................6.6-5203Ascorbyl palmitate ...................................................................1222Ash insoluble in hydrochloric acid (2.8.1.) ........................... 249Ash leaf.......................................................................................1222Asparagine monohydrate .......................................................1223Aspartame..................................................................................1224Aspartic acid..............................................................................1225Assay of 1,8-cineole in essential oils (2.8.11.) ...................... 250Assay of diphtheria vaccine (adsorbed) (2.7.6.) ....................217Assay of heparin (2.7.5.) ............................................................217Assay of heparin in coagulation factors (2.7.12.) ................ 230Assay of hepatitis A vaccine (2.7.14.) ..................................... 232Assay of hepatitis B vaccine (rDNA) (2.7.15.) ...................... 233Assay of human anti-D immunoglobulin (2.7.13.)............... 230Assay of human antithrombin III (2.7.17.) ............................ 234Assay of human coagulation factor II (2.7.18.).................... 234Assay of human coagulation factor IX (2.7.11.)................... 229Assay of human coagulation factor VII (2.7.10.) ................. 228Assay of human coagulation factor VIII (2.7.4.)...................216Assay of human coagulation factor X (2.7.19.) .................... 235Assay of human coagulation factor XI (2.7.22.) .................. 238Assay of human plasmin inhibitor (2.7.25.).................6.5-4786Assay of human protein C (2.7.30.) ...............................6.2-3631Assay of human protein S (2.7.31.)................................6.2-3632Assay of human von Willebrand factor (2.7.21.) ................. 237Assay of interferons (5.6.)......................................................... 627Assay of pertussis vaccine (2.7.7.)........................................... 222Assay of pertussis vaccine (acellular) (2.7.16.) .................... 233Assay of poliomyelitis vaccine (inactivated), in vivo(2.7.20.) ...................................................................................... 235

Assay of tetanus vaccine (adsorbed) (2.7.8.) ........................ 223Assays (2.5.) ................................................................................. 137Astemizole .................................................................................1226Atenolol ...............................................................................6.4-4574Atomic absorption spectrometry (2.2.23.) .............................. 37Atomic emission spectrometry (2.2.22.).................................. 36Atomic emission spectrometry, inductively coupled plasma-(2.2.57.) ........................................................................................ 96

Atracurium besilate .................................................................1230Atropine ..............................................................................6.3-4044Atropine sulphate..............................................................6.3-4045Aujeszky’s disease vaccine (inactivated) for pigs................ 859Aujeszky’s disease vaccine (live) for pigs for parenteraladministration .......................................................................... 861

Avian infectious bronchitis vaccine (inactivated)................ 864Avian infectious bronchitis vaccine (live) ....................6.1-3371Avian infectious bursal disease vaccine (inactivated) ........ 867Avian infectious bursal disease vaccine (live) ...................... 869Avian infectious encephalomyelitis vaccine (live) ............... 871Avian infectious laryngotracheitis vaccine (live)................. 872Avian live virus vaccines : tests for extraneous agents inbatches of finished product (2.6.25.)................................... 202

Avian paramyxovirus 1 (Newcastle disease) vaccine(inactivated) .............................................................................. 937

Avian paramyxovirus 3 vaccine (inactivated)....................... 874Avian tuberculin purified protein derivative...................... 3146Avian viral tenosynovitis vaccine (live).................................. 875Avian viral vaccines : tests for extraneous agents in seed lots(2.6.24.) .............................................................................6.5-4778

Azaperone for veterinary use ................................................1234



Azathioprine..............................................................................1236Azelastine hydrochloride........................................................1236Azithromycin......................................................................6.3-4047

BBacampicillin hydrochloride...........................................6.1-3409Bacitracin...................................................................................1245Bacitracin zinc ..........................................................................1247Baclofen .....................................................................................1250Bacterial cells used for the manufacture of plasmid vectorsfor human use .................................................................6.6-5152

Bacterial endotoxins (2.6.14.).........................................6.6-5077Bacterial endotoxins, guidelines for using the test for(5.1.10.) .............................................................................6.6-5130

Bambuterol hydrochloride..................................................... 1251Barbados aloes ......................................................................... 1137Barbital.......................................................................................1252Barium chloride dihydrate for homoeopathicpreparations ............................................................................1073

Barium sulphate.......................................................................1253Basic butylated methacrylate copolymer............................1254BCG for immunotherapy .................................................6.3-4053BCG vaccine, freeze-dried ........................................................ 759Bearberry leaf ....................................................................6.1-3410Beclometasone dipropionate, anhydrous ....................6.4-4579Beclometasone dipropionate monohydrate ................6.4-4581Bee for homoeopathic preparations, honey.......................1079Beeswax, white .........................................................................1260Beeswax, yellow........................................................................ 1261Belladonna leaf......................................................................... 1261Belladonna leaf dry extract, standardised...................6.3-4059Belladonna leaf tincture, standardised................................1264Belladonna, prepared .......................................................6.2-3698Benazepril hydrochloride................................................6.3-4060Bendroflumethiazide ..............................................................1266Benfluorex hydrochloride ......................................................1267Benperidol .................................................................................1269Benserazide hydrochloride .............................................6.4-4583Bentonite ............................................................................6.4-4584Benzalkonium chloride....................................................6.4-4585Benzalkonium chloride solution ...................................6.4-4587Benzathine benzylpenicillin ..................................................1283Benzbromarone........................................................................1273Benzethonium chloride ..........................................................1275Benzocaine ................................................................................ 1276Benzoic acid .......................................................................6.4-4589Benzoin, Siam...........................................................................1277Benzoin, Sumatra ....................................................................1278Benzoin tincture, Siam ...........................................................1278Benzoin tincture, Sumatra.....................................................1279Benzoyl peroxide, hydrous ....................................................1280Benzyl alcohol ...................................................................6.5-4837Benzyl benzoate .......................................................................1283Benzylpenicillin, benzathine .................................................1283Benzylpenicillin potassium....................................................1285Benzylpenicillin, procaine......................................................1287Benzylpenicillin sodium .........................................................1288Betacarotene .............................................................................1290Betacyclodextrin ...................................................................... 1291Betacyclodextrin, poly(hydroxypropyl) ether .............6.3-4170Betadex ...................................................................................... 1291Betahistine dihydrochloride ..................................................1292Betahistine mesilate ................................................................1293Betamethasone.........................................................................1295Betamethasone acetate ..........................................................1297Betamethasone dipropionate ................................................1298Betamethasone sodium phosphate......................................1300Betamethasone valerate ..................................................6.3-4062Betaxolol hydrochloride .........................................................1303

Bezafibrate ................................................................................1304Bifonazole...........................................................................6.5-4838Bilberry fruit, dried .................................................................1307Bilberry fruit dry extract, fresh, refined andstandardised.....................................................................6.4-4624

Bilberry fruit, fresh...........................................................6.1-3412Biological assays (2.7.) .............................................................. 209Biological assays and tests, statistical analysis of results of(5.3.)............................................................................................ 571

Biological indicators of sterilisation (5.1.2.) ........................ 527Biological products, general texts on (5.2.).......................... 547Biological products, terminology used in monographs on(5.2.1.)......................................................................................... 547

Biological tests (2.6.) ................................................................. 155Biotin ..........................................................................................1308Biperiden hydrochloride.........................................................1309Biphasic insulin injection....................................................... 2140Biphasic isophane insulin injection ..................................... 2140Birch leaf.............................................................................6.2-3699Bisacodyl.................................................................................... 1312Bismuth subcarbonate............................................................ 1313Bismuth subgallate...........................................................6.5-4839Bismuth subnitrate, heavy ..................................................... 1315Bismuth subsalicylate ............................................................. 1316Bisoprolol fumarate..........................................................6.4-4590Bistort rhizome ........................................................................ 1317Bitter fennel ..............................................................................1873Bitter-fennel fruit oil................................................................ 1318Bitter-fennel herb oil ........................................................6.5-4840Bitterness value (2.8.15.).......................................................... 255Bitter-orange epicarp and mesocarp.............................6.3-4064Bitter-orange-epicarp and mesocarp tincture ....................1320Bitter-orange flower .........................................................6.3-4065Bitter-orange-flower oil ...........................................................2490Black horehound ..................................................................... 1321Bleomycin sulphate .................................................................1322Blood and blood components, empty sterile containers ofplasticised poly(vinyl chloride) for (3.2.4.) ......................... 381

Blood and blood components, materials for containers for(3.1.1.)......................................................................................... 339

Blood and blood components, sets for the transfusion of(3.2.6.) ........................................................................................ 383

Blood and blood components, sterile plastic containers for(3.2.3.) ........................................................................................ 379

Blood, anticoagulant and preservative solutions for .......1200Blood, sterile containers of plasticised poly(vinyl chloride)containing anticoagulant solution (3.2.5.) ......................... 382

Bogbean leaf .............................................................................1323Boiling point (2.2.12.) ..................................................................31Boldo leaf...................................................................................1324Boldo leaf dry extract.......................................................6.1-3415Borage (starflower) oil, refined......................................6.6-5209Borax ..........................................................................................1326Boric acid...................................................................................1327Botulinum antitoxin .................................................................. 965Botulinum toxin type A for injection...................................1327Bovine infectious rhinotracheitis vaccine (live) .................. 924Bovine insulin........................................................................... 2135Bovine leptospirosis vaccine (inactivated)............................ 876Bovine parainfluenza virus vaccine (live)............................. 878Bovine respiratory syncytial virus vaccine (live)................. 879Bovine serum............................................................................1329Bovine tuberculin purified protein derivative ................... 3147Bovine viral diarrhoea vaccine (inactivated)........................ 880Bromazepam ............................................................................. 1331Bromhexine hydrochloride ....................................................1332Bromocriptine mesilate ..........................................................1333Bromperidol ..............................................................................1335Bromperidol decanoate ..........................................................1337



Brompheniramine maleate.....................................................1339Brotizolam .................................................................................1340Brucellosis vaccine (live) (Brucella melitensis Rev. 1 strain)for veterinary use..................................................................... 881

Buccal tablets and sublingual tablets.................................... 734Buckwheat herb ....................................................................... 1341Budesonide.........................................................................6.6-5209Bufexamac .................................................................................1344Buffer solutions (4.1.3.) ...................................................6.4-4540Buffer solutions (4.1.3.) ...................................................6.6-5125Buflomedil hydrochloride ......................................................1345Bulk density and tapped density of powders(2.9.34.) .............................................................................6.5-4789

Bumetanide ...............................................................................1346Bupivacaine hydrochloride ....................................................1347Buprenorphine ..................................................................6.6-5212Buprenorphine hydrochloride .......................................6.6-5213Buserelin.............................................................................6.3-4067Buspirone hydrochloride........................................................1353Busulfan.....................................................................................1355Butcher’s broom................................................................6.1-3416Butylated methacrylate copolymer, basic...........................1254Butylhydroxyanisole................................................................1357Butylhydroxytoluene...............................................................1357Butyl parahydroxybenzoate...................................................1358

CCabergoline ...............................................................................1363Cachets ......................................................................................... 719Cadmium sulphate hydrate for homoeopathicpreparations ............................................................................ 1074

Caffeine ...............................................................................6.1-3421Caffeine monohydrate......................................................6.5-4849Calcifediol ..................................................................................1366Calcipotriol, anhydrous ..........................................................1367Calcipotriol monohydrate ......................................................1370Calcitonin (salmon)..................................................................1372Calcitriol..............................................................................6.4-4595Calcium (2.4.3.)............................................................................111Calcium acetate ........................................................................ 1376Calcium ascorbate....................................................................1377Calcium carbonate ............................................................6.2-3703Calcium carboxymethylcellulose .......................................... 1422Calcium chloride dihydrate....................................................1378Calcium chloride hexahydrate ..............................................1379Calcium dobesilate monohydrate ..................................6.2-3703Calcium folinate ................................................................6.4-4596Calcium glucoheptonate.........................................................1383Calcium gluconate ............................................................6.3-4073Calcium gluconate, anhydrous ......................................6.3-4074Calcium gluconate for injection.....................................6.3-4074Calcium glycerophosphate.....................................................1386Calcium hydrogen phosphate, anhydrous ...................6.4-4598Calcium hydrogen phosphate dihydrate ......................6.4-4599Calcium hydroxide ...................................................................1389Calcium in adsorbed vaccines (2.5.14.) ................................. 142Calcium iodide tetrahydrate for homoeopathic prepara-tions .......................................................................................... 1074

Calcium lactate, anhydrous ...................................................1389Calcium lactate monohydrate ...............................................1390Calcium lactate pentahydrate ...............................................1390Calcium lactate trihydrate...................................................... 1391Calcium levofolinate pentahydrate ......................................1392Calcium levulinate dihydrate.................................................1394Calcium pantothenate.............................................................1395Calcium pentetate (sodium) for radiopharmaceuticalpreparations .....................................................................6.3-4001

Calcium phosphate ...........................................................6.4-4600Calcium stearate................................................................6.3-4076

Calcium sulphate dihydrate............................................6.4-4601Calendula flower ......................................................................1398Calf coronavirus diarrhoea vaccine (inactivated)................ 882Calf rotavirus diarrhoea vaccine (inactivated)..................... 884Calicivirosis vaccine (inactivated), feline............................... 909Calicivirosis vaccine (live), feline .............................................910Camphor, D- ............................................................................... 1400Camphor, racemic .................................................................... 1401Canine adenovirus vaccine (inactivated) .............................. 885Canine adenovirus vaccine (live) ............................................ 886Canine distemper vaccine (live) .............................................. 887Canine leptospirosis vaccine (inactivated)............................ 888Canine parainfluenza virus vaccine (live)............................. 890Canine parvovirosis vaccine (inactivated)............................. 891Canine parvovirosis vaccine (live) .......................................... 892Cape aloes.................................................................................. 1138Capillary electrophoresis (2.2.47) (5.8.) .......................6.6-5143Capillary electrophoresis (2.2.47.).................................6.6-5047Capillary viscometer method (2.2.9.)....................................... 27Caprylic acid.............................................................................. 1402Caprylocaproyl macrogolglycerides..................................... 1403Capsicum.............................................................................6.2-3704Capsicum oleoresin, refined and quantified ...................... 1405Capsicum tincture, standardised .......................................... 1406Capsules ........................................................................................717Capsules and tablets, disintegration of (2.9.1.) ..........6.3-3943Capsules, gastro-resistant......................................................... 718Capsules, hard ............................................................................ 718Capsules, intrauterine......................................................6.3-3977Capsules, modified-release ....................................................... 718Capsules, oromucosal ............................................................... 734Capsules, rectal........................................................................... 745Capsules, soft .............................................................................. 718Capsules, vaginal........................................................................ 752Captopril .................................................................................... 1407Caraway fruit............................................................................. 1408Caraway oil ................................................................................ 1408Carbachol................................................................................... 1410Carbamazepine ..........................................................................1411Carbasalate calcium................................................................. 1412Carbidopa .................................................................................. 1413Carbimazole ...............................................................................1414Carbocisteine ............................................................................ 1415Carbomers ..........................................................................6.4-4602Carbon dioxide ..........................................................................1417Carbon dioxide in gases (2.5.24.) ..................................6.3-3915Carbon monoxide (15O) ............................................................. 982Carbon monoxide in gases (2.5.25.)..............................6.3-3915Carboplatin.........................................................................6.5-4850Carboprost trometamol .......................................................... 1420Carboxymethylcellulose calcium .......................................... 1422Carboxymethylcellulose sodium........................................... 1423Carboxymethylcellulose sodium, cross-linked ............6.5-4865Carboxymethylcellulose sodium, low-substituted............. 1424Carisoprodol.............................................................................. 1421Carmellose calcium.................................................................. 1422Carmellose sodium .................................................................. 1423Carmellose sodium and microcrystalline cellulose ..........2422Carmellose sodium, low-substituted .................................... 1424Carmustine ................................................................................ 1425Carnauba wax ........................................................................... 1425Carprofen for veterinary use ..........................................6.3-4077Carrageenan.......................................................................6.6-5219Carteolol hydrochloride.......................................................... 1426Carvedilol................................................................................... 1427Cascara ....................................................................................... 1429Cascara dry extract, standardised ........................................ 1430Cassia oil .............................................................................6.2-3707Castor oil, hydrogenated ........................................................ 1432



Castor oil, polyoxyl ..................................................................2304Castor oil, polyoxyl hydrogenated........................................2303Castor oil, refined .................................................................... 1433Castor oil, virgin....................................................................... 1434Catgut, sterile............................................................................1045Catgut, sterile, in distributor for veterinary use ...............1057CD34/CD45+ cells in haematopoietic products, numerationof (2.7.23.).................................................................................. 238

Cefaclor ...............................................................................6.5-4851Cefadroxil monohydrate ..................................................6.5-4853Cefalexin monohydrate....................................................6.1-3425Cefalotin sodium ...................................................................... 1440Cefamandole nafate ..........................................................6.6-5220Cefapirin sodium...................................................................... 1443Cefatrizine propylene glycol.................................................. 1444Cefazolin sodium...................................................................... 1445Cefepime dihydrochloride monohydrate ............................ 1448Cefixime ..................................................................................... 1450Cefoperazone sodium ......................................................6.4-4603Cefotaxime sodium .................................................................. 1453Cefoxitin sodium ...................................................................... 1455Cefradine.................................................................................... 1457Ceftazidime pentahydrate ...............................................6.5-4854Ceftazidime pentahydrate with sodium carbonate forinjection ............................................................................6.5-4856

Ceftriaxone sodium.................................................................. 1461Cefuroxime axetil ..................................................................... 1462Cefuroxime sodium.................................................................. 1464Celiprolol hydrochloride......................................................... 1465Cell count and viability, nucleated (2.7.29.) ......................... 243Cell cultures for the production of veterinary vaccines(5.2.4.) ........................................................................................ 553

Cell substrates for the production of vaccines for human use(5.2.3.) ...............................................................................6.3-3963

Cellular products, microbiological control of (2.6.27.) ...... 205Cellulose acetate ...............................................................6.3-4078Cellulose acetate butyrate...................................................... 1468Cellulose acetate phthalate.............................................6.3-4079Cellulose, microcrystalline..............................................6.3-4080Cellulose (microcrystalline) and carmellose sodium........2422Cellulose, powdered .........................................................6.3-4084Centaury .................................................................................... 1477Centella ...................................................................................... 1477Cetirizine dihydrochloride ..............................................6.2-3715Cetostearyl alcohol .................................................................. 1480Cetostearyl alcohol (type A), emulsifying ....................6.2-3717Cetostearyl alcohol (type B), emulsifying....................6.2-3718Cetostearyl isononanoate....................................................... 1484Cetrimide ................................................................................... 1484Cetyl alcohol ............................................................................. 1485Cetyl palmitate.......................................................................... 1486Cetylpyridinium chloride........................................................ 1486Ceylon cinnamon bark oil ...............................................6.2-3721Ceylon cinnamon leaf oil........................................................1544CFC assay for human haematopoietic progenitor cells(2.7.28.) ...................................................................................... 242

Chamomile flower, Roman..................................................... 1487Characterisation of crystalline and partially crystalline solidsby X-ray powder diffraction (XRPD) (2.9.33.) ...........6.3-3945

Characters section in monographs (5.11.)............................ 659Charcoal, activated ...........................................................6.3-4088Chenodeoxycholic acid .......................................................... 1489Chewing gum, medicated, dissolution test for (2.9.25.) .... 304Chewing gums, medicated ....................................................... 719Chicken anaemia vaccine (live), infectious..................6.5-4817Chicken flocks free from specified pathogens forthe production and quality control of vaccines(5.2.2.) ...............................................................................6.6-5137

Chitosan hydrochloride ...................................................6.5-4859

Chlamydiosis vaccine (inactivated), feline ............................911Chloral hydrate......................................................................... 1491Chlorambucil............................................................................. 1492Chloramine ................................................................................ 3103Chloramphenicol...................................................................... 1492Chloramphenicol palmitate ................................................... 1493Chloramphenicol sodium succinate..................................... 1495Chlorcyclizine hydrochloride ................................................ 1496Chlordiazepoxide ..................................................................... 1497Chlordiazepoxide hydrochloride .......................................... 1498Chlorhexidine diacetate.......................................................... 1499Chlorhexidine digluconate solution ....................................1500Chlorhexidine dihydrochloride .............................................1502Chlorides (2.4.4.) ........................................................................ 112Chlorobutanol, anhydrous .....................................................1503Chlorobutanol hemihydrate ..................................................1504Chlorocresol ..............................................................................1504Chloroquine phosphate ..........................................................1505Chloroquine sulphate..............................................................1506Chlorothiazide ..........................................................................1507Chlorphenamine maleate ................................................6.1-3427Chlorpromazine hydrochloride.............................................1509Chlorpropamide........................................................................ 1510Chlorprothixene hydrochloride ............................................ 1511Chlortalidone ............................................................................ 1513Chlortetracycline hydrochloride........................................... 1514Cholecalciferol .......................................................................... 1516Cholecalciferol concentrate (oily form)........................6.5-4860Cholecalciferol concentrate (powder form).................6.5-4861Cholecalciferol concentrate (water-dispersibleform) ..................................................................................6.5-4863

Cholera vaccine ...........................................................................761Cholera vaccine, freeze-dried ...................................................761Cholera vaccine (inactivated, oral) ......................................... 762Cholesterol ................................................................................1524Cholesterol in oils rich in omega-3 acids, total (2.4.32.) ... 132Chondroitin sulphate sodium.........................................6.3-4095Chromatographic separation techniques (2.2.46.) ....6.4-4407Chromatography, gas (2.2.28.).................................................. 45Chromatography, liquid (2.2.29.) ............................................. 46Chromatography, paper (2.2.26.).............................................. 43Chromatography, size-exclusion (2.2.30.)............................... 47Chromatography, supercritical fluid (2.2.45.) ........................71Chromatography, thin-layer (2.2.27.) ....................................... 43Chromium (51Cr) edetate injection ................................6.2-3677Chymotrypsin............................................................................1527Ciclopirox...................................................................................1528Ciclopirox olamine ...................................................................1530Ciclosporin ................................................................................ 1531Cilastatin sodium ..............................................................6.1-3428Cilazapril ....................................................................................1534Cimetidine...........................................................................6.6-5221Cimetidine hydrochloride................................................6.6-5223Cinchocaine hydrochloride....................................................1538Cinchona bark ...................................................................6.2-3720Cinchona liquid extract, standardised.................................1540Cineole........................................................................................ 1541Cineole in essential oils, 1,8-, assay of (2.8.11.) ................... 250Cinnamon ..................................................................................1542Cinnamon bark oil, Ceylon .............................................6.2-3721Cinnamon leaf oil, Ceylon ......................................................1544Cinnamon tincture...................................................................1545Cinnarizine ................................................................................1545Ciprofibrate ...............................................................................1547Ciprofloxacin.............................................................................1548Ciprofloxacin hydrochloride..................................................1550Circular dichroism (2.2.41.) ....................................................... 66Cisapride monohydrate........................................................... 1551Cisapride tartrate .....................................................................1552



Cisplatin ..............................................................................6.3-4097Citalopram hydrobromide ...............................................6.4-4605Citalopram hydrochloride ...............................................6.4-4607Citric acid, anhydrous .............................................................1554Citric acid monohydrate .........................................................1555Citronella oil..............................................................................1556Cladribine ..................................................................................1557Clarithromycin..........................................................................1559Clarity and degree of opalescence of liquids (2.2.1.).............21Clary sage oil............................................................................. 1561Classical swine-fever vaccine (live, prepared in cellcultures) ............................................................................6.2-3669

Clazuril for veterinary use .....................................................1562Clebopride malate ....................................................................1564Clemastine fumarate ........................................................6.1-3430Clenbuterol hydrochloride.....................................................1567Clindamycin hydrochloride....................................................1568Clindamycin phosphate ..........................................................1570Clioquinol .................................................................................. 1571Clobazam ...................................................................................1572Clobetasol propionate.............................................................1573Clobetasone butyrate .......................................................6.6-5225Clodronate disodium tetrahydrate ................................6.2-3722Clofazimine................................................................................1577Clofibrate ...................................................................................1578Clomifene citrate ......................................................................1579Clomipramine hydrochloride.................................................1580Clonazepam...............................................................................1582Clonidine hydrochloride..................................................6.3-4102Clopamide...........................................................................6.1-3431Closantel sodium dihydrate for veterinary use .................1584Clostridium botulinum vaccine for veterinary use ............. 894Clostridium chauvoei vaccine for veterinary use.......6.4-4567Clostridium novyi alpha antitoxin for veterinary use ........ 973Clostridium novyi (type B) vaccine for veterinaryuse......................................................................................6.6-5185

Clostridium perfringens beta antitoxin for veterinary use..................................................................................................... 974

Clostridium perfringens epsilon antitoxin for veterinary use..................................................................................................... 975

Clostridium perfringens vaccine for veterinary use ........... 897Clostridium septicum vaccine for veterinary use................ 899Closures and containers for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 352

Closures and containers for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 378

Closures and tubing, silicone elastomer for (3.1.9.)........... 358Closures for containers for aqueous parenteral preparations,for powders and for freeze-dried powders, rubber(3.2.9.) ........................................................................................ 386

Clotrimazole.......................................................................6.1-3433Clove ...........................................................................................1587Clove oil .....................................................................................1588Cloxacillin sodium....................................................................1589Clozapine ...................................................................................1590Coagulation factor II, assay of (2.7.18.)................................. 234Coagulation factor IX, human...............................................2064Coagulation factor IX, human, assay of (2.7.11.)................. 229Coagulation factors, activated (2.6.22.)................................. 198Coagulation factors, assay of heparin (2.7.12.) ................... 230Coagulation factor VII, human ............................................. 2061Coagulation factor VII, human, assay of (2.7.10.) ............... 228Coagulation factor VIII, human.....................................6.6-5264Coagulation factor VIII, human, assay of (2.7.4.).................216Coagulation factor VIII (rDNA), human .............................2063Coagulation factor X, assay of (2.7.19.) ................................. 235Coagulation factor XI, human...............................................2065Coagulation factor XI, human, assay of (2.7.22.) ................ 238

Coated granules ......................................................................... 724Coated tablets ............................................................................. 749Cocaine hydrochloride............................................................1592Coccidiosis vaccine (live) for chickens .........................6.2-3665Coconut oil, refined..........................................................6.2-3723Coconut oil, refined..........................................................6.6-5226Cocoyl caprylocaprate.............................................................1594Codeine ...............................................................................6.1-3434Codeine hydrochloride dihydrate.........................................1596Codeine phosphate hemihydrate..........................................1598Codeine phosphate sesquihydrate .......................................1599Codergocrine mesilate .....................................................6.3-4103Cod-liver oil, farmed .........................................................6.3-4105Cod-liver oil (type A).........................................................6.3-4109Cod-liver oil (type B).........................................................6.3-4113Cola ............................................................................................. 1611Colchicine .................................................................................. 1612Cold-water vibriosis vaccine (inactivated) forsalmonids..........................................................................6.2-3671

Colestyramine ........................................................................... 1613Colibacillosis vaccine (inactivated), neonatal piglet........... 934Colibacillosis vaccine (inactivated), neonatal ruminant .... 936Colistimethate sodium ............................................................ 1614Colistin sulphate ...................................................................... 1615Colloidal anhydrous silica ......................................................2877Colloidal hydrated silica .........................................................2877Colloidal silica, hydrophobic .................................................2878Colloidal silver, for external use ...........................................2879Colony-forming cell assay for human haematopoieticprogenitor cells (2.7.28.) ........................................................ 242

Colophony ..................................................................................1617Coloration of liquids (2.2.2.)...................................................... 22Common stinging nettle for homoeopathicpreparations............................................................................1075

Comparative table of porosity of sintered-glass filters(2.1.2.)............................................................................................15

Complexometric titrations (2.5.11.)........................................ 140Composition of fatty acids by gas chromatography(2.4.22.) .............................................................................6.6-5071

Composition of fatty acids in oils rich in omega-3 acids(2.4.29.) .............................................................................6.6-5073

Compressed lozenges................................................................ 734Concentrated solutions for haemodialysis .........................2022Concentrates for injections or infusions............................... 736Concentrates for intrauterine solutions.......................6.3-3977Conductivity (2.2.38.) .................................................................. 59Coneflower herb, purple ........................................................2785Coneflower root, narrow-leaved............................................2483Coneflower root, pale..............................................................2602Coneflower root, purple .........................................................2787Conjugated estrogens .............................................................1824Consistency by penetrometry, measurement of(2.9.9.) ...............................................................................6.2-3641

Containers (3.2.)......................................................................... 373Containers and closures for parenteral preparations andophthalmic preparations, polypropylene for (3.1.6.)........ 352

Containers and closures for pharmaceutical use, plastic(3.2.2.) ........................................................................................ 378

Containers and tubing for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 356

Containers for aqueous solutions for infusion, plastic(3.2.2.1.) ..................................................................................... 379

Containers for aqueous solutions for intravenous infusion,materials based on plasticised poly(vinyl chloride) for(3.1.14.) ...................................................................................... 366

Containers for dry dosage forms for oral administration,materials based on non-plasticised poly(vinyl chloride) for(3.1.11.)..............................................................................6.4-4417



Containers for human blood and blood components,materials based on plasticised poly(vinyl chloride) for(3.1.1.1.) ..................................................................................... 339

Containers for human blood and blood components,materials for (3.1.1.) ................................................................ 339

Containers for human blood and blood components, plastic,sterile (3.2.3.) ............................................................................ 379

Containers for non-injectable aqueous solutions, materialsbased on non-plasticised poly(vinyl chloride) for(3.1.10.) ...................................................................................... 360

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene with additives for (3.1.5.) ..... 349

Containers for parenteral preparations and for ophthalmicpreparations, polyethylene without additives for(3.1.4.)......................................................................................... 348

Containers for pharmaceutical use, glass (3.2.1.)...... 6.6-5117Containers for preparations not for parenteral use,polyethylene terephthalate for (3.1.15) .............................. 369

Containers of plasticised poly(vinyl chloride) for humanblood and blood components, empty sterile (3.2.4.) ........ 381

Containers of plasticised poly(vinyl chloride) for human bloodcontaining anticoagulant solution, sterile (3.2.5.)............ 382

Contamination, microbial : microbial enumeration tests(2.6.12.) .............................................................................6.5-4769

Contamination, microbial : test for specified micro-organisms(2.6.13.) .............................................................................6.5-4773

Content uniformity of single-dose preparations (2.9.6.).... 278Control of impurities in substances for pharmaceutical use(5.10.).................................................................................6.5-4805

Control of microbiological quality, alternative methods for(5.1.6.)......................................................................................... 532

Copolymer, basic butylated methacrylate ..........................1254Copolymer, methacrylic acid - ethyl acrylate (1:1) ....6.2-3781Copolymer, methacrylic acid - ethyl acrylate (1:1) dispersion30 per cent .......................................................................6.3-4220

Copolymer (type A), ammonio methacrylate ..................... 1175Copolymer (type B), ammonio methacrylate ......................1176Copovidone.................................................................................1617Copper acetate monohydrate for homoeopathic prepara-tions ..........................................................................................1075

Copper for homoeopathic preparations.............................. 1076Copper sulphate, anhydrous.................................................. 1619Copper sulphate pentahydrate..............................................1620Coriander ...................................................................................1620Coriander oil ............................................................................. 1621Cortisone acetate .....................................................................1622Cotton, absorbent ....................................................................1624Cottonseed oil, hydrogenated .......................................6.2-3724Couch grass rhizome ..............................................................1625Creams.................................................................................6.3-3980Cresol, crude .............................................................................1626Croscarmellose sodium....................................................6.5-4865Crospovidone .....................................................................6.3-4119Crotamiton ................................................................................1629Crystalline and partially crystalline solids, characterisationby X-ray powder diffraction (XRPD) of (2.9.33.) ......6.3-3945

Cutaneous application, liquid preparations for................... 728Cutaneous application, powders for .............................6.3-3978Cutaneous application, semi-solid preparations for ..6.3-3979Cutaneous application, veterinary liquid preparationsfor ................................................................................................ 752

Cutaneous foams........................................................................ 728Cyanocobalamin .......................................................................1630Cyanocobalamin (57Co) capsules ............................................ 983Cyanocobalamin (57Co) solution ............................................. 984Cyanocobalamin (58Co) capsules ............................................ 985Cyanocobalamin (58Co) solution ............................................. 986Cyclizine hydrochloride...................................................6.2-3725Cyclopentolate hydrochloride ........................................6.4-4608

Cyclophosphamide...................................................................1633Cyproheptadine hydrochloride ......................................6.5-4866Cyproterone acetate ................................................................1635Cysteine hydrochloride monohydrate .................................1636Cystine........................................................................................1637Cytarabine .................................................................................1638

DDacarbazine............................................................................... 1641Dalteparin sodium ...................................................................1642Danaparoid sodium .................................................................1644Dandelion herb with root................................................6.6-5231Dandelion root...................................................................6.6-5232Dapsone .....................................................................................1646Daunorubicin hydrochloride .................................................1647D-Camphor ................................................................................. 1400Decyl oleate ...............................................................................1648Deferoxamine mesilate............................................................1649Degree of coloration of liquids (2.2.2.).................................... 22Dembrexine hydrochloride monohydrate for veteri-nary use ...................................................................................1650

Demeclocycline hydrochloride.............................................. 1651Density of powders, bulk density and tapped(2.9.34.) .............................................................................6.5-4789

Density of solids (2.2.42.) ................................................6.6-5046Density of solids, gas pycnometric (2.9.23.)................6.2-3642Density, relative (2.2.5.) .............................................................. 25Dental type silica......................................................................2878Depressor substances (2.6.11.)................................................ 166Deptropine citrate....................................................................1653Dequalinium chloride..............................................................1654Desflurane ..........................................................................6.4-4613Desipramine hydrochloride ...................................................1655Deslanoside ...............................................................................1656Desmopressin.....................................................................6.5-4871Desogestrel ................................................................................1658Desoxycortone acetate............................................................1659Detector tubes, gas (2.1.6.) .........................................................17Determination of aflatoxin B1 in herbal drugs (2.8.18.).... 256Determination of essential oils in herbal drugs (2.8.12.).. 251Determination of nitrogen by sulphuric acid digestion(2.5.9.) ........................................................................................ 139

Determination of primary aromatic amino-nitrogen(2.5.8.) ........................................................................................ 139

Determination of tannins in herbal drugs (2.8.14.)............ 255Determination of water by distillation (2.2.13.) .....................31Detomidine hydrochloride for veterinary use ...................1660Devil’s claw dry extract...........................................................1662Devil’s claw root ................................................................6.2-3729Dexamethasone ........................................................................1663Dexamethasone acetate...................................................6.3-4123Dexamethasone isonicotinate ...............................................1666Dexamethasone sodium phosphate .....................................1667Dexchlorpheniramine maleate ..............................................1669Dexpanthenol............................................................................1670Dextran 1 for injection.....................................................6.3-4124Dextran 40 for injection ..................................................6.3-4125Dextran 60 for injection ..................................................6.3-4126Dextran 70 for injection ..................................................6.3-4127Dextranomer .............................................................................1675Dextrans, molecular mass distribution in (2.2.39.) .............. 60Dextrin.................................................................................6.4-4614Dextromethorphan hydrobromide ....................................... 1676Dextromoramide tartrate .......................................................1677Dextropropoxyphene hydrochloride.............................6.6-5233Diazepam ...................................................................................1679Diazoxide ...................................................................................1680Dibrompropamidine diisetionate .......................................... 1681Dibutyl phthalate .....................................................................1682



Dichloromethane......................................................................2387Diclazuril for veterinary use..................................................1683Diclofenac potassium ..............................................................1685Diclofenac sodium ...................................................................1686Dicloxacillin sodium ................................................................1687Dicycloverine hydrochloride..................................................1689Didanosine.................................................................................1689Dienestrol .................................................................................. 1691Diethylcarbamazine citrate ....................................................1693Diethylene glycol and ethylene glycol in ethoxylatedsubstances (2.4.30.)..................................................................131

Diethylene glycol monoethyl ether......................................1694Diethylene glycol palmitostearate........................................1695Diethyl phthalate ..............................................................6.1-3441Diethylstilbestrol ......................................................................1696Diffraction, laser light, particle size analysis by(2.9.31.) ............................................................................6.6-5103

Diflunisal.............................................................................6.4-4615Digitalis leaf ..............................................................................1698Digitoxin..................................................................................... 1700Digoxin ................................................................................6.6-5234Dihydralazine sulphate, hydrated .................................6.1-3442Dihydrocodeine hydrogen tartrate....................................... 1704Dihydroergocristine mesilate ................................................ 1705Dihydroergotamine mesilate ..........................................6.4-4616Dihydroergotamine tartrate .................................................. 1709Dihydrostreptomycin sulphate for veterinary use .....6.2-3730Dihydrotachysterol .................................................................. 1712Diltiazem hydrochloride ..................................................6.1-3446Dimenhydrinate.................................................................6.5-4873Dimercaprol............................................................................... 1716Dimethylacetamide ...................................................................1717Dimethylaniline, N,N- (2.4.26.)................................................ 127Dimethyl sulfoxide ................................................................... 1716Dimeticone .........................................................................6.2-3732Dimetindene maleate .............................................................. 1719Dinoprostone ............................................................................ 1722Dinoprost trometamol............................................................. 1720Diosmin ...................................................................................... 1723Dioxan and ethylene oxide (2.4.25.) ...................................... 126Dip concentrates ........................................................................ 753Diphenhydramine hydrochloride.......................................... 1725Diphenoxylate hydrochloride ................................................ 1726Diphtheria and tetanus toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ............................................. 241

Diphtheria and tetanus vaccine (adsorbed) ......................... 763Diphtheria and tetanus vaccine (adsorbed, reduced antigen(s)content)...................................................................................... 764

Diphtheria antitoxin .................................................................. 965Diphtheria, tetanus and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 765

Diphtheria, tetanus and pertussis (acellular, component)vaccine (adsorbed)................................................................... 767

Diphtheria, tetanus and pertussis vaccine (adsorbed) ..... 768Diphtheria, tetanus and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .............................. 770

Diphtheria, tetanus, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) .......... 771

Diphtheria, tetanus, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 774

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) .................. 775

Diphtheria, tetanus, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) .................................................................. 778

Diphtheria, tetanus, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 780

Diphtheria, tetanus, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed).......................................6.3-3983

Diphtheria, tetanus, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)................................................................... 785

Diphtheria, tetanus, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 787

Diphtheria vaccine (adsorbed) ................................................ 789Diphtheria vaccine (adsorbed), assay of (2.7.6.) ...................217Diphtheria vaccine (adsorbed, reduced antigen content).. 791Dipivefrine hydrochloride ...................................................... 1727Dipotassium clorazepate ........................................................ 1728Dipotassium phosphate .......................................................... 1729Diprophylline ............................................................................ 1730Dipyridamole............................................................................. 1731Dirithromycin.....................................................................6.1-3447Disintegration of suppositories and pessaries (2.9.2.) ....... 265Disintegration of tablets and capsules (2.9.1.) ...........6.3-3943Disodium edetate ..................................................................... 1734Disodium phosphate, anhydrous...................................6.3-4128Disodium phosphate dihydrate............................................. 1735Disodium phosphate dodecahydrate ............................6.1-3449Disopyramide ............................................................................ 1737Disopyramide phosphate........................................................ 1738Dispersible tablets ..................................................................... 750Dissolution, apparent (2.9.43.).......................................6.1-3327Dissolution, intrinsic (2.9.29.) ................................................. 309Dissolution test for lipophilic solid dosage forms(2.9.42.) ...................................................................................... 332

Dissolution test for solid dosage forms (2.9.3.) ..........6.6-5091Dissolution test for transdermal patches (2.9.4.)................ 275Distemper vaccine (live), canine ............................................. 887Distemper vaccine (live) for mustelids .................................. 900Distillation range (2.2.11.).......................................................... 30Distribution estimation by analytical sieving, particle-size(2.9.38) (5.8.)....................................................................6.6-5145

Distribution estimation by analytical sieving, particle-size(2.9.38.) .............................................................................6.6-5112

Disulfiram .................................................................................. 1739Dithranol.................................................................................... 1740DL-Methionine ...........................................................................2380DL-α-Tocopheryl hydrogen succinate...................................3093Dobutamine hydrochloride.....................................................1741Docetaxel trihydrate.........................................................6.6-5236Docusate sodium...................................................................... 1743Dodecyl gallate ......................................................................... 1744Dog rose..................................................................................... 1744Domperidone ............................................................................ 1745Domperidone maleate............................................................. 1747Dopamine hydrochloride........................................................ 1749Dopexamine dihydrochloride ................................................ 1750Dorzolamide hydrochloride ................................................... 1752Dosage units, uniformity of (2.9.40.) ............................6.1-3325Dosulepin hydrochloride........................................................ 1753Doxapram hydrochloride........................................................ 1754Doxazosin mesilate .................................................................. 1756Doxepin hydrochloride ....................................................6.4-4618Doxorubicin hydrochloride.................................................... 1759Doxycycline hyclate ................................................................. 1760Doxycycline monohydrate...................................................... 1762Doxylamine hydrogen succinate....................................6.1-3451Droperidol.................................................................................. 1765Droppers (2.1.1.)............................................................................15Drop point (2.2.17.)...................................................................... 33Drops (nasal) and sprays (liquid nasal) ................................. 731Drops, oral ................................................................................... 730Drospirenone .....................................................................6.5-4874Dry extracts ........................................................................6.1-3344Dry residue of extracts (2.8.16.).............................................. 256



Duck plague vaccine (live) ....................................................... 901Duck viral hepatitis type I vaccine (live)............................... 902Dwarf pine oil ........................................................................... 1766Dydrogesterone .................................................................6.3-4128

EEar drops and ear sprays.......................................................... 720Ear powders ................................................................................ 720Ear preparations......................................................................... 719Ear preparations, semi-solid .................................................... 720Ear sprays and ear drops.......................................................... 720Ear tampons................................................................................ 720Ear washes................................................................................... 720Ebastine ..................................................................................... 1771Econazole .................................................................................. 1772Econazole nitrate ..................................................................... 1773Edetic acid ................................................................................. 1774Edrophonium chloride............................................................ 1775Effervescent granules................................................................ 724Effervescent powders ................................................................ 739Effervescent tablets ................................................................... 749Efficacy of antimicrobial preservation (5.1.3.) ............6.6-5129Efficacy of veterinary vaccines and immunosera, evaluationof (5.2.7.) ...........................................................................6.1-3335

Egg drop syndrome ′76 vaccine (inactivated)...................... 904Elder flower............................................................................... 1776Electrophoresis (2.2.31) (5.8.) ........................................6.6-5143Electrophoresis (2.2.31.) ..................................................6.6-5041Electrophoresis, capillary (2.2.47) (5.8.) ......................6.6-5143Electrophoresis, capillary (2.2.47.) ................................6.6-5047Eleutherococcus....................................................................... 1777Emedastine difumarate........................................................... 1779Emetine hydrochloride heptahydrate.................................. 1780Emetine hydrochloride pentahydrate.................................. 1781Empty sterile containers of plasticised poly(vinyl chloride)for human blood and blood components (3.2.4.) ............. 381

Emulsifying cetostearyl alcohol (type A) .....................6.2-3717Emulsifying cetostearyl alcohol (type B).....................6.2-3718Emulsions, solutions and suspensions, oral ........................ 729Enalaprilat dihydrate .............................................................. 1784Enalapril maleate ..................................................................... 1782Encephalitis vaccine (inactivated), tick-borne ..................... 845Endotoxins, bacterial (2.6.14.)........................................6.6-5077Endotoxins, bacterial, guidelines for using the test for(5.1.10.) .............................................................................6.6-5130

Enilconazole for veterinary use............................................ 1785Enoxaparin sodium.................................................................. 1787Enoxolone.................................................................................. 1788Enzootic pneumonia vaccine (inactivated), porcine ..6.5-4818Ephedrine, anhydrous............................................................. 1789Ephedrine hemihydrate .......................................................... 1790Ephedrine hydrochloride ....................................................... 1791Ephedrine hydrochloride, racemic....................................... 1792Epinastine hydrochloride ................................................6.6-5241Epinephrine........................................................................6.2-3686Epinephrine tartrate ................................................................1114Epirubicin hydrochloride ....................................................... 1793Equine herpesvirus vaccine (inactivated) ............................. 905Equine influenza vaccine (inactivated) ................................. 907Equisetum stem........................................................................ 1794Ergocalciferol.....................................................................6.3-4133Ergometrine maleate............................................................... 1797Ergotamine tartrate................................................................. 1798Erysipelas vaccine (inactivated), swine ................................. 955Erythritol ............................................................................6.3-4134Erythromycin ............................................................................ 1801Erythromycin estolate.............................................................1803Erythromycin ethylsuccinate.................................................1806Erythromycin lactobionate ....................................................1808

Erythromycin stearate ............................................................ 1810Erythropoietin concentrated solution................................. 1813Eserine salicylate .....................................................................2677Eserine sulphate.......................................................................2678Esketamine hydrochloride ......................................................1817Esomeprazole magnesium trihydrate...........................6.3-4136Essential oils ............................................................................... 680Essential oils, assay of 1,8-cineole in (2.8.11.) ..................... 250Essential oils, fatty oils and resinified essential oils in(2.8.7.)......................................................................................... 250

Essential oils, foreign esters in (2.8.6.) ................................. 250Essential oils in herbal drugs, determination of (2.8.12.).. 251Essential oils, odour and taste (2.8.8.) .................................. 250Essential oils, residue on evaporation (2.8.9.)..................... 250Essential oils, solubility in alcohol (2.8.10.)......................... 250Essential oils, water in (2.8.5.) ................................................ 249Ester value (2.5.2.) ..................................................................... 137Estradiol benzoate............................................................6.1-3455Estradiol hemihydrate............................................................. 1819Estradiol valerate ..................................................................... 1821Estriol .........................................................................................1822Estrogens, conjugated ............................................................1824Etacrynic acid ....................................................................6.5-4879Etamsylate ..........................................................................6.2-3737Ethacridine lactate monohydrate..................................6.3-4138Ethambutol hydrochloride..............................................6.1-3456Ethanol (96 per cent) ..............................................................1829Ethanol, anhydrous ................................................................. 1831Ethanol content and alcoholimetric tables (2.9.10.) .......... 281Ether ...........................................................................................1833Ether, anaesthetic....................................................................1834Ethinylestradiol ........................................................................1834Ethionamide..............................................................................1835Ethosuximide ............................................................................1836Ethoxylated substances, ethylene glycol and diethyleneglycol in (2.4.30.) ......................................................................131

Ethyl acetate .............................................................................1838Ethyl acrylate - methacrylic acid copolymer (1:1) .....6.2-3781Ethyl acrylate - methacrylic acid copolymer (1:1) dispersion30 per cent .......................................................................6.3-4220

Ethylcellulose ........................................................................... 1841Ethylenediamine ......................................................................1843Ethylene glycol and diethylene glycol in ethoxylatedsubstances (2.4.30.)..................................................................131

Ethylene glycol monopalmitostearate.................................1842Ethylene glycol monostearate...............................................1842Ethylene oxide and dioxan (2.4.25.) ...................................... 126Ethylhexanoic acid, 2- (2.4.28.) ............................................... 129Ethylmorphine hydrochloride...............................................1843Ethyl oleate ...............................................................................1838Ethyl parahydroxybenzoate...................................................1839Ethyl parahydroxybenzoate sodium ....................................1840Etidronate disodium................................................................1844Etilefrine hydrochloride .........................................................1845Etodolac .....................................................................................1847Etofenamate ..............................................................................1849Etofylline....................................................................................1850Etomidate .................................................................................. 1851Etoposide ...................................................................................1852Eucalyptus leaf .........................................................................1857Eucalyptus oil ....................................................................6.2-3738Eugenol ......................................................................................1859European goldenrod ...............................................................2000European viper venom antiserum.......................................... 970Evaluation of efficacy of veterinary vaccines and immunosera(5.2.7.)................................................................................6.1-3335

Evaluation of safety of each batch of veterinary vaccines andimmunosera (5.2.9.) ................................................................ 567



Evaluation of safety of veterinary vaccines and immunosera(5.2.6.) ........................................................................................ 556

Evening primrose oil, refined.........................................6.6-5242Extractable volume of parenteral preparations, test for(2.9.17.)....................................................................................... 287

Extracts ...............................................................................6.1-3343Extracts, dry .......................................................................6.1-3344Extracts, dry residue of (2.8.16.)............................................. 256Extracts, liquid...................................................................6.1-3343Extracts, loss on drying of (2.8.17.)........................................ 256Extracts, soft ......................................................................6.1-3344Extraneous agents in viral vaccines for human use, tests for(2.6.16.) ...................................................................................... 190

Extraneous agents : tests in batches of finished product ofavian live virus vaccines (2.6.25.)......................................... 202

Extraneous agents : tests in seed lots of avian viral vaccines(2.6.24.) .............................................................................6.5-4778

Eye drops ..................................................................................... 721Eye lotions................................................................................... 721Eye preparations ........................................................................ 721Eye preparations, semi-solid .................................................... 722

FF0 concept to steam sterilisation of aqueous preparations,application of (5.1.5.) .....................................................6.3-3958

Factor II, human coagulation, assay of (2.7.18.) ................. 234Factor IX, human coagulation ..............................................2064Factor IX, human coagulation, assay of (2.7.11.) ................ 229Factor VII, human coagulation............................................. 2061Factor VII, human coagulation, assay of (2.7.10.) .............. 228Factor VIII, human coagulation ....................................6.6-5264Factor VIII, human coagulation, assay of (2.7.4.) ................216Factor VIII (rDNA), human coagulation .............................2063Factor X, human coagulation, assay of (2.7.19.) ................. 235Factor XI, human coagulation ..............................................2065Factor XI, human coagulation, assay of (2.7.22.)................ 238Falling ball viscometer method (2.2.49.) ................................ 84Famotidine.................................................................................1865Fat, hard..............................................................................6.3-4164Fatty acids, composition by gas chromatography(2.4.22.) .............................................................................6.6-5071

Fatty acids in oils rich in omega-3 acids, composition of(2.4.29.) .............................................................................6.6-5073

Fatty oils, alkaline impurities in (2.4.19.) ..............................117Fatty oils and herbal drugs, heavy metals in (2.4.27.) ....... 128Fatty oils and resinified essential oils in essential oils(2.8.7.)......................................................................................... 250

Fatty oils, foreign oils in, by thin-layer chromatography(2.4.21.) .......................................................................................117

Fatty oils, identification by thin-layer chromatography(2.3.2.) ...............................................................................6.6-5067

Fatty oils, sterols in (2.4.23.) ................................................... 120Fatty oils, vegetable..........................................................6.4-4553Fc function of immunoglobulin, test for (2.7.9.) ........6.5-4785Febantel for veterinary use....................................................1870Felbinac ......................................................................................1866Feline calicivirosis vaccine (inactivated) ............................... 909Feline calicivirosis vaccine (live)..............................................910Feline chlamydiosis vaccine (inactivated)..............................911Feline infectious enteritis (feline panleucopenia) vaccine(inactivated) .............................................................................. 912

Feline infectious enteritis (feline panleucopenia) vaccine(live) .............................................................................................913

Feline leukaemia vaccine (inactivated)...................................914Feline panleucopenia vaccine (inactivated).......................... 912Feline panleucopenia vaccine (live) ........................................913Feline viral rhinotracheitis vaccine (inactivated) .................916Feline viral rhinotracheitis vaccine (live)...............................917Felodipine ..................................................................................1867

Felypressin.................................................................................1869Fenbendazole for veterinary use .......................................... 1871Fenbufen ....................................................................................1872Fennel, bitter.............................................................................1873Fennel, sweet............................................................................. 1874Fenofibrate ................................................................................1875Fenoterol hydrobromide......................................................... 1876Fentanyl .....................................................................................1878Fentanyl citrate.........................................................................1879Fenticonazole nitrate ..............................................................1880Fenugreek...........................................................................6.6-5245Fermentation, products of ....................................................... 693Ferric chloride hexahydrate ..................................................1882Ferrous fumarate .....................................................................1883Ferrous gluconate.............................................................6.3-4141Ferrous sulphate, dried...........................................................1885Ferrous sulphate heptahydrate......................................6.6-5245Feverfew.....................................................................................1887Fexofenadine hydrochloride ..................................................1888Fibrinogen, human ..................................................................2066Fibrin sealant kit ......................................................................1890Filgrastim concentrated solution ..................................6.3-4142Finasteride................................................................................. 1891Fineness, powder (2.9.35.) ..............................................6.2-3648Fish oil, rich in omega-3 acids...............................................1893Flavoxate hydrochloride .........................................................1895Flecainide acetate ....................................................................1896Flocculation value (Lf) of diphtheria and tetanus toxins andtoxoids (Ramon assay) (2.7.27.) ............................................ 241

Flowability (2.9.16.) ................................................................... 286Flow cytometry (2.7.24.) ........................................................... 240Flubendazole ............................................................................1898Flucloxacillin magnesium octahydrate ........................6.2-3741Flucloxacillin sodium ..............................................................1899Fluconazole...............................................................................1900Flucytosine ................................................................................1902Fludarabine phosphate...........................................................1903Fludeoxyglucose (18F) injection .....................................6.2-3678Fludrocortisone acetate..........................................................1906Flumazenil .................................................................................1908Flumazenil (N-[11C]methyl) injection ..................................... 989Flumequine ...............................................................................1909Flumetasone pivalate .............................................................. 1910Flunarizine dihydrochloride.................................................. 1911Flunitrazepam........................................................................... 1913Flunixin meglumine for veterinary use............................... 1914Fluocinolone acetonide .......................................................... 1915Fluocortolone pivalate............................................................ 1916Fluorescein ................................................................................ 1918Fluorescein sodium ................................................................. 1919Fluorides (2.4.5.) ........................................................................ 112Fluorimetry (2.2.21.) ................................................................... 36Fluorodopa (18F) (prepared by electrophilic substitution)injection ..................................................................................... 990

Fluorouracil...............................................................................1920Fluoxetine hydrochloride .......................................................1922Flupentixol dihydrochloride ..................................................1924Fluphenazine decanoate ........................................................1926Fluphenazine dihydrochloride..............................................1928Fluphenazine enantate ...........................................................1927Flurazepam monohydrochloride ..........................................1930Flurbiprofen .......................................................................6.5-4883Fluspirilene ...............................................................................1932Flutamide...................................................................................1933Fluticasone propionate ...........................................................1934Flutrimazole..............................................................................1936Fluvastatin sodium ...........................................................6.4-4623Fluvoxamine maleate .......................................................6.3-4144Foams, cutaneous ...................................................................... 728



Foams, intrauterine ..........................................................6.3-3977Foams, medicated ...................................................................... 723Foams, rectal ............................................................................... 746Foams, vaginal ............................................................................ 752Folic acid....................................................................................1938Foot-and-mouth disease (ruminants) vaccine(inactivated) ...............................................................................918

Foreign esters in essential oils (2.8.6.) .................................. 250Foreign matter (2.8.2.) .............................................................. 249Foreign oils in fatty oils by thin-layer chromatography(2.4.21.) .......................................................................................117

Formaldehyde, free (2.4.18.) .....................................................117Formaldehyde solution (35 per cent) ..................................1939Formoterol fumarate dihydrate ............................................1940Foscarnet sodium hexahydrate......................................6.5-4884Fosfomycin calcium .................................................................1943Fosfomycin sodium..................................................................1945Fosfomycin trometamol ..........................................................1946Fowl cholera vaccine (inactivated) ......................................... 920Fowl-pox vaccine (live) .............................................................. 921Framycetin sulphate................................................................1947Frangula bark ...........................................................................1949Frangula bark dry extract, standardised .....................6.5-4885Frankincense, Indian .............................................................. 2128Free formaldehyde (2.4.18.) ......................................................117Freezing point (2.2.18.)............................................................... 35Fresh bilberry fruit dry extract, refined andstandardised.....................................................................6.4-4624

Friability of granules and spheroids (2.9.41.) ...................... 330Friability of uncoated tablets (2.9.7) (5.8.) ..................6.6-5144Friability of uncoated tablets (2.9.7.)............................6.6-5100Fructose ..................................................................................... 1951Fucus .......................................................................................... 2213Fumitory ....................................................................................1952Functional groups and ions, identification reactions of(2.3.1.)......................................................................................... 103

Furosemide................................................................................1953Furunculosis vaccine (inactivated, oil-adjuvanted, injectable)for salmonids ...................................................................6.2-3668

Fusidic acid ...............................................................................1954

GGalactose.............................................................................6.3-4151Gallamine triethiodide ............................................................1959Gallium (67Ga) citrate injection ............................................... 992Ganciclovir..........................................................................6.6-5249Gargles.......................................................................................... 733Garlic for homoeopathic preparations ................................1077Garlic powder............................................................................ 1961Gas adsorption, specific surface area by (2.9.26)(5.8.)...................................................................................6.6-5144

Gas adsorption, specific surface area by (2.9.26.)......6.6-5100Gas chromatography (2.2.28.) ................................................... 45Gas detector tubes (2.1.6.) ..........................................................17Gases, carbon dioxide in (2.5.24.)..................................6.3-3915Gases, carbon monoxide in (2.5.25.) .............................6.3-3915Gases, nitrogen monoxide and nitrogen dioxide in(2.5.26.) ...................................................................................... 146

Gases, nitrous oxide in (2.5.35.).............................................. 152Gases, oxygen in (2.5.27.) ................................................6.3-3916Gases, water in (2.5.28.)............................................................ 146Gas-gangrene antitoxin, mixed ................................................ 966Gas-gangrene antitoxin (novyi) ............................................... 966Gas-gangrene antitoxin (perfringens) .................................... 967Gas-gangrene antitoxin (septicum)......................................... 968Gas pycnometric density of solids (2.9.23.) .................6.2-3642Gastro-resistant capsules .......................................................... 718Gastro-resistant granules.......................................................... 724Gastro-resistant tablets ............................................................. 750

Gelatin .................................................................................6.3-4151Gels.......................................................................................6.3-3980Gels for injections ...................................................................... 737Gemcitabine hydrochloride....................................................1963Gemfibrozil .........................................................................6.6-5250General notices (1.)...........................................................6.5-4759General texts on biological products (5.2.) .......................... 547General texts on microbiology (5.1.)...................................... 525Gene transfer medicinal products for human use(5.14.).................................................................................6.6-5149

Gentamicin sulphate................................................................1965Gentian root ..............................................................................1967Gentian tincture .......................................................................1968Gestodene ...........................................................................6.5-4889Ginger ..................................................................................6.2-3751Gingival solutions ...................................................................... 733Ginkgo dry extract, refined and quantified.................6.1-3461Ginkgo leaf .........................................................................6.5-4891Ginseng....................................................................................... 1971Glass containers for pharmaceutical use (3.2.1.) ....... 6.6-5117Glibenclamide ...........................................................................1972Gliclazide.................................................................................... 1974Glimepiride ................................................................................1975Glipizide ..............................................................................6.6-5252Glossary.........................................................................................717Glossary (dosage forms) ............................................................717Glucagon, human.....................................................................1979Glucose, anhydrous ..........................................................6.3-4153Glucose, liquid ...................................................................6.2-3752Glucose, liquid, spray-dried.............................................6.4-4629Glucose monohydrate ......................................................6.3-4154Glutamic acid ............................................................................1984Glutathione.........................................................................6.1-3463Glycerol ......................................................................................1987Glycerol (85 per cent)..............................................................1988Glycerol dibehenate .................................................................1990Glycerol distearate ................................................................... 1991Glycerol monocaprylate..........................................................1992Glycerol monocaprylocaprate................................................1993Glycerol monolinoleate ...........................................................1994Glycerol mono-oleate........................................................6.3-4155Glycerol monostearate 40-55.................................................1996Glycerol triacetate.................................................................... 3112Glyceryl trinitrate solution..............................................6.4-4629Glycine........................................................................................1998Glycyrrhizate ammonium....................................................... 1179Goldenrod ..................................................................................1999Goldenrod, European..............................................................2000Goldenseal rhizome..........................................................6.6-5254Gonadorelin acetate ................................................................2003Gonadotrophin, chorionic ......................................................2004Gonadotrophin, equine serum, for veterinary use............2005Goserelin ....................................................................................2005Gramicidin .................................................................................2007Granisetron hydrochloride..............................................6.3-4156Granules ....................................................................................... 723Granules and powders for oral solutions andsuspensions............................................................................... 729

Granules and powders for syrups........................................... 730Granules and spheroids, friability of (2.9.41.)...................... 330Granules, coated......................................................................... 724Granules, effervescent............................................................... 724Granules, gastro-resistant......................................................... 724Granules, modified-release ....................................................... 724Greater celandine..................................................................... 2010Griseofulvin ............................................................................... 2011Guaiacol ..............................................................................6.5-4892Guaifenesin................................................................................ 2014Guanethidine monosulphate ................................................. 2015



Guar .....................................................................................6.6-5255Guar galactomannan ........................................................6.6-5256Guidelines for using the test for bacterial endotoxins(5.1.10.) .............................................................................6.6-5130

Guidelines for using the test for sterility (5.1.9.) .......6.3-3958

HHaematopoietic products, numeration of CD34/CD45+ cellsin (2.7.23.).................................................................................. 238

Haematopoietic progenitor cells, human, colony-forming cellassay for (2.7.28.) ..................................................................... 242

Haematopoietic stem cells, human ...............................6.3-4165Haemodiafiltration and for haemofiltration, solutionsfor ..............................................................................................2025

Haemodialysis, concentrated solutions for ........................2022Haemodialysis solutions, concentrated, water fordiluting..............................................................................6.3-4163

Haemodialysis, solutions for..................................................2022Haemofiltration and for haemodiafiltration,solutions for ............................................................................2025

Haemophilus type b (conjugate), diphtheria, tetanus andpertussis (acellular, component) vaccine (adsorbed)....... 771

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component) and poliomyelitis(inactivated) vaccine (adsorbed) ..................................6.3-3983

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis (acellular, component), hepatitis B (rDNA) andpoliomyelitis (inactivated) vaccine (adsorbed) .................. 780

Haemophilus type b (conjugate), diphtheria, tetanus,pertussis and poliomyelitis (inactivated) vaccine(adsorbed).................................................................................. 787

Haemophilus type b conjugate vaccine........................6.3-3985Haemorrhagic disease vaccine (inactivated), rabbit ........... 949Halofantrine hydrochloride ...................................................2027Haloperidol................................................................................2028Haloperidol decanoate............................................................2030Halothane .................................................................................. 2031Hamamelis leaf ..................................................................6.1-3471Hard capsules.............................................................................. 718Hard fat ...............................................................................6.3-4164Hard paraffin............................................................................. 2612Harmonisation, pharmacopoeial (5.8.).........................6.6-5143Hawthorn berries .....................................................................2034Hawthorn leaf and flower ...............................................6.6-5261Hawthorn leaf and flower dry extract ..........................6.6-5262Hawthorn leaf and flower liquid extract, quantified........2037Heavy bismuth subnitrate ...................................................... 1315Heavy kaolin.......................................................................6.3-4183Heavy magnesium carbonate .........................................6.5-4921Heavy magnesium oxide..................................................6.4-4662Heavy metals (2.4.8.) ................................................................. 112Heavy metals in herbal drugs and fatty oils (2.4.27.)......... 128Hedera helix for homoeopathic preparations....................1078Helium........................................................................................2038Heparin, assay of (2.7.5.) ...........................................................217Heparin calcium ................................................................6.4-4635Heparin in coagulation factors, assay of (2.7.12.)............... 230Heparins, low-molecular-mass ............................................... 2041Heparin sodium.................................................................6.4-4636Hepatitis A immunoglobulin, human ..................................2068Hepatitis A (inactivated) and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 794

Hepatitis A vaccine, assay of (2.7.14.) .................................... 232Hepatitis A vaccine (inactivated, adsorbed) ................6.6-5171Hepatitis A vaccine (inactivated, virosome) ................6.6-5172Hepatitis B immunoglobulin for intravenous administration,human ......................................................................................2069

Hepatitis B immunoglobulin, human ..................................2069

Hepatitis B (rDNA), diphtheria and tetanus vaccine(adsorbed).................................................................................. 765

Hepatitis B (rDNA), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ........................ 774

Hepatitis B (rDNA), diphtheria, tetanus, pertussis (acellular,component), poliomyelitis (inactivated) and haemophilustype b conjugate vaccine (adsorbed) ................................... 780

Hepatitis B vaccine (rDNA)...................................................... 800Hepatitis B vaccine (rDNA), assay of (2.7.15.) ..................... 233Hepatitis C virus (HCV), validation of nucleic acidamplification techniques for the detection of HCV RNA inplasma pools : Guidelines ....................................................... 195

Heptaminol hydrochloride .....................................................2043Herbal drug preparations......................................................... 684Herbal drugs ............................................................................... 684Herbal drugs and fatty oils, heavy metals in (2.4.27.)........ 128Herbal drugs, determination of aflatoxin B1 in (2.8.18.)... 256Herbal drugs, determination of essential oils in herbal drugs(2.8.12.) ...................................................................................... 251

Herbal drugs, determination of tannins (2.8.14.) ............... 255Herbal drugs for homoeopathic preparations ............6.5-4827Herbal drugs : sampling and sample preparation(2.8.20.) ...................................................................................... 258

Herbal teas................................................................................... 685Herpes zoster (shingles) vaccine (live) .........................6.3-3991Hexamidine diisetionate .........................................................2044Hexetidine..................................................................................2045Hexobarbital..............................................................................2047Hexosamines in polysaccharide vaccines (2.5.20.) ............. 143Hexylresorcinol.........................................................................2047Highly purified water .......................................................6.3-4342Histamine (2.6.10.)..................................................................... 165Histamine dihydrochloride ....................................................2049Histamine phosphate ..............................................................2049Histidine.....................................................................................2050Histidine hydrochloride monohydrate ................................ 2051Homatropine hydrobromide ..................................................2052Homatropine methylbromide ................................................2053Homoeopathic preparations ..................................................1065Homoeopathic preparations, arsenious trioxide for ........1073Homoeopathic preparations, calcium iodide tetrahydratefor .............................................................................................. 1074

Homoeopathic preparations, common stinging nettlefor ..............................................................................................1075

Homoeopathic preparations, copper acetate monohydratefor ..............................................................................................1075

Homoeopathic preparations, copper for............................. 1076Homoeopathic preparations, garlic for ...............................1077Homoeopathic preparations, hedera helix for...................1078Homoeopathic preparations, herbal drugs for ...........6.5-4827Homoeopathic preparations, honey bee for.......................1079Homoeopathic preparations, hyoscyamus for ...................1079Homoeopathic preparations, hypericum for ......................1080Homoeopathic preparations, iron for .................................. 1081Homoeopathic preparations, mother tinctures for...........1072Homoeopathic preparations, oriental cashew for.............1082Homoeopathic preparations, saffron for.............................1084Homoeopathic stocks (methods of preparation of) andpotentisation....................................................................6.1-3385

Honey .........................................................................................2055Honey bee for homoeopathic preparations........................1079Hop strobile........................................................................6.1-3472Human α-1-proteinase inhibitor ....................................6.2-3762Human albumin injection, iodinated (125I)............................ 993Human albumin solution ................................................6.6-5263Human anti-D immunoglobulin .....................................6.2-3757Human anti-D immunoglobulin, assay of (2.7.13.).............. 230Human anti-D immunoglobulin for intravenousadministration ........................................................................2059



Human antithrombin III, assay of (2.7.17.) ........................... 234Human antithrombin III concentrate ..................................2060Human coagulation factor II, assay of (2.7.18.)................... 234Human coagulation factor IX................................................2064Human coagulation factor IX, assay of (2.7.11.).................. 229Human coagulation factor VII .............................................. 2061Human coagulation factor VII, assay of (2.7.10.) ................ 228Human coagulation factor VIII......................................6.6-5264Human coagulation factor VIII, assay of (2.7.4.)..................216Human coagulation factor VIII (rDNA)...............................2063Human coagulation factor X, assay of (2.7.19.) ................... 235Human coagulation factor XI................................................2065Human coagulation factor XI, assay of (2.7.22.) ................. 238Human fibrinogen....................................................................2066Human haematopoietic progenitor cells, colony-forming cellassay for (2.7.28.) ..................................................................... 242

Human haematopoietic stem cells ................................6.3-4165Human hepatitis A immunoglobulin ...................................2068Human hepatitis B immunoglobulin ...................................2069Human hepatitis B immunoglobulin for intravenousadministration ........................................................................2069

Human insulin .......................................................................... 2137Human measles immunoglobulin.........................................2069Human normal immunoglobulin...................................6.6-5266Human normal immunoglobulin for intravenousadministration .................................................................6.6-5268

Human papillomavirus vaccine (rDNA) .......................6.6-5175Human plasma for fractionation....................................6.2-3759Human plasma (pooled and treated for virusinactivation) .....................................................................6.3-4168

Human plasmin inhibitor, assay of (2.7.25.)................6.5-4786Human protein C, assay of (2.7.30.) ..............................6.2-3631Human protein S, assay of (2.7.31.) ..............................6.2-3632Human prothrombin complex...............................................2076Human rabies immunoglobulin............................................2078Human rubella immunoglobulin ..........................................2079Human tetanus immunoglobulin .........................................2079Human varicella immunoglobulin........................................2080Human varicella immunoglobulin for intravenousadministration ........................................................................ 2081

Human von Willebrand factor............................................... 2081Human von Willebrand factor, assay of (2.7.21.) ................ 237Hyaluronidase ..........................................................................2082Hydralazine hydrochloride ....................................................2083Hydrochloric acid, concentrated...........................................2085Hydrochloric acid, dilute ........................................................2085Hydrochlorothiazide.........................................................6.4-4637Hydrocodone hydrogen tartrate 2.5-hydrate ..............6.4-4639Hydrocortisone..................................................................6.5-4897Hydrocortisone acetate........................................................... 2091Hydrocortisone hydrogen succinate ....................................2092Hydrogenated arachis oil ................................................6.2-3694Hydrogenated castor oil ......................................................... 1432Hydrogenated cottonseed oil .........................................6.2-3724Hydrogenated soya-bean oil............................................6.2-3837Hydrogenated vegetable oils, nickel in (2.4.31.)...................131Hydrogenated wool fat............................................................3226Hydrogen peroxide solution (30 per cent) .........................2094Hydrogen peroxide solution (3 per cent)............................2094Hydromorphone hydrochloride ............................................2095Hydrophobic colloidal silica ..................................................2878Hydrous wool fat ......................................................................3227Hydroxocobalamin acetate.....................................................2096Hydroxocobalamin chloride...................................................2098Hydroxocobalamin sulphate ..................................................2099Hydroxycarbamide ................................................................... 2100Hydroxyethylcellulose............................................................. 2102Hydroxyethylmethylcellulose ................................................2390Hydroxyethyl salicylate........................................................... 2101

Hydroxyl value (2.5.3.) .............................................................. 137Hydroxypropylbetadex.....................................................6.3-4170Hydroxypropylcellulose .......................................................... 2105Hydroxypropylmethylcellulose.......................................6.3-4171Hydroxypropylmethylcellulose phthalate.................... 6.3-4174Hydroxyzine hydrochloride ................................................... 2106Hymecromone........................................................................... 2107Hyoscine..................................................................................... 2108Hyoscine butylbromide ........................................................... 2109Hyoscine hydrobromide.......................................................... 2110Hyoscyamine sulphate ............................................................ 2112Hyoscyamus for homoeopathic preparations ....................1079Hypericum ..........................................................................6.2-3839Hypericum for homoeopathic preparations .......................1080Hypromellose .....................................................................6.3-4171Hypromellose phthalate .................................................. 6.3-4174

IIbuprofen ............................................................................6.1-3479Iceland moss.............................................................................. 2121ICH (5.8.).............................................................................6.6-5143Ichthammol ........................................................................6.3-4177Identification (2.3.) .................................................................... 103Identification and control of residual solvents (2.4.24.).... 121Identification of fatty oils by thin-layer chromatography(2.3.2.) ...............................................................................6.6-5067

Identification of phenothiazines by thin-layerchromatography (2.3.3.) ......................................................... 107

Identification reactions of ions and functional groups(2.3.1.)......................................................................................... 103

Idoxuridine ................................................................................ 2122Ifosfamide .................................................................................. 2123Imipenem ................................................................................... 2125Imipramine hydrochloride ..............................................6.5-4903Immunochemical methods (2.7.1.) ......................................... 209Immunoglobulin for human use, anti-T lymphocyte,animal.......................................................................................1203

Immunoglobulin for intravenous administration, humananti-D ........................................................................................2059

Immunoglobulin for intravenous administration, humanhepatitis B ...............................................................................2069

Immunoglobulin for intravenous administration, humannormal ...............................................................................6.6-5268

Immunoglobulin for intravenous administration, humanvaricella.................................................................................... 2081

Immunoglobulin, human anti-D ....................................6.2-3757Immunoglobulin, human anti-D, assay of (2.7.13.) ............. 230Immunoglobulin, human hepatitis A...................................2068Immunoglobulin, human hepatitis B ..................................2069Immunoglobulin, human measles ........................................2069Immunoglobulin, human normal ..................................6.6-5266Immunoglobulin, human rabies ...........................................2078Immunoglobulin, human rubella .........................................2079Immunoglobulin, human tetanus.........................................2079Immunoglobulin, human varicella .......................................2080Immunoglobulin, test for anticomplementary activity of(2.6.17.)..............................................................................6.6-5081

Immunoglobulin, test for Fc function of (2.7.9.)........6.5-4785Immunological veterinary medicinal products, substances ofanimal origin for the production of (5.2.5.) ..............6.5-4801

Immunosera and vaccines, phenol in (2.5.15.) .................... 142Immunosera and vaccines, veterinary, evaluation of efficacyof (5.2.7.) ...........................................................................6.1-3335

Immunosera and vaccines, veterinary, evaluation of safety(5.2.6.) ........................................................................................ 556

Immunosera and vaccines, veterinary, evaluation of thesafety of each batch (5.2.9.) ................................................... 567

Immunosera for human use, animal...................................... 685Immunosera for veterinary use............................................... 687



Implants ....................................................................................... 737Impurities in substances for pharmaceutical use, control of(5.10.).................................................................................6.5-4805

Indapamide................................................................................ 2127Indian frankincense................................................................. 2128Indicators, relationship between approximate pH and colour(2.2.4.) .......................................................................................... 25

Indinavir sulphate.................................................................... 2130Indium (111In) chloride solution .............................................. 994Indium (111In) oxine solution ................................................... 995Indium (111In) pentetate injection........................................... 996Indometacin .............................................................................. 2132Inductively coupled plasma-atomic emission spectrometry(2.2.57.) ........................................................................................ 96

Inductively coupled plasma-mass spectrometry (2.2.58.).... 98Infectious bovine rhinotracheitis vaccine (live)................... 924Infectious bronchitis vaccine (inactivated), avian ............... 864Infectious bronchitis vaccine (live), avian....................6.1-3371Infectious bursal disease vaccine (inactivated), avian........ 867Infectious bursal disease vaccine (live), avian ..................... 869Infectious chicken anaemia vaccine (live) ...................6.5-4817Infectious encephalomyelitis vaccine (live), avian .............. 871Infectious laryngotracheitis vaccine (live), avian ................ 872Influenza vaccine (split virion, inactivated) ......................... 801Influenza vaccine (surface antigen, inactivated)................. 803Influenza vaccine (surface antigen, inactivated, prepared incell cultures) ....................................................................6.4-4557

Influenza vaccine (surface antigen, inactivated,virosome) ................................................................................... 806

Influenza vaccine (whole virion, inactivated) ...................... 808Influenza vaccine (whole virion, inactivated, prepared in cellcultures) ............................................................................6.4-4559

Infrared absorption spectrophotometry (2.2.24.) ................. 39Infusions ...................................................................................... 736Inhalation gas, krypton (81MKr) .............................................1000Inhalation, preparations for..................................................... 739Inhalation, preparations for : aerodynamic assessment of fineparticles (2.9.18.) ..................................................................... 287

Injectable insulin preparations ............................................. 2146Injections ..................................................................................... 736Injections, gels for...................................................................... 737Injections or infusions, concentrates for .............................. 736Injections or infusions, powders for ...................................... 736Inositol, myo- ............................................................................2460Inserts, ophthalmic.................................................................... 722Insulin aspart ............................................................................ 2133Insulin, bovine .......................................................................... 2135Insulin, human.......................................................................... 2137Insulin injection, biphasic ...................................................... 2140Insulin injection, biphasic isophane .................................... 2140Insulin injection, isophane......................................................2141Insulin injection, soluble .........................................................2141Insulin lispro ..............................................................................2141Insulin, porcine......................................................................... 2144Insulin preparations, injectable ............................................ 2146Insulin zinc injectable suspension ....................................... 2148Insulin zinc injectable suspension (amorphous) .............. 2149Insulin zinc injectable suspension (crystalline) ................ 2149Interferon alfa-2 concentrated solution .............................. 2150Interferon beta-1a concentrated solution....................6.5-4904Interferon gamma-1b concentrated solution ..................... 2153Interferons, assay of (5.6.)........................................................ 627International System (SI) units (1.) ..............................6.5-4759Intramammary preparations for veterinary use.................. 725Intraruminal devices ................................................................. 725Intrauterine capsules .......................................................6.3-3977Intrauterine foams ............................................................6.3-3977Intrauterine preparations for veterinary use ..............6.3-3977Intrauterine solutions, suspensions..............................6.3-3977

Intrauterine sticks.............................................................6.3-3977Intrauterine tablets...........................................................6.3-3977Intrinsic dissolution (2.9.29.) .................................................. 309In vivo assay of poliomyelitis vaccine (inactivated)(2.7.20.) ...................................................................................... 235

Iobenguane (123I) injection....................................................... 997Iobenguane (131I) injection for diagnostic use ..................... 998Iobenguane (131I) injection for therapeutic use ................... 999Iobenguane sulphate for radiopharmaceuticalpreparations.....................................................................6.6-5189

Iodinated (125I) human albumin injection ............................. 993Iodinated povidone..................................................................2734Iodine.......................................................................................... 2156Iodine value (2.5.4.) ................................................................... 137Iohexol........................................................................................ 2157Ionic concentration, potentiometric determination of usingion-selective electrodes (2.2.36.)............................................. 58

Ions and functional groups, identification reactions of(2.3.1.)......................................................................................... 103

Ion-selective electrodes, potentiometric determination ofionic concentration (2.2.36.) ................................................... 58

Iopamidol ................................................................................... 2160Iopanoic acid............................................................................. 2162Iopromide............................................................................6.5-4907Iotalamic acid............................................................................ 2163Iotrolan....................................................................................... 2164Ioxaglic acid .............................................................................. 2167Ipecacuanha liquid extract, standardised ........................... 2168Ipecacuanha, prepared.....................................................6.2-3770Ipecacuanha root ..................................................................... 2170Ipecacuanha tincture, standardised..................................... 2171Ipratropium bromide........................................................6.2-3771Iron (2.4.9.) .................................................................................. 115Iron for homoeopathic preparations ................................... 1081Irrigation, preparations for ...................................................... 743Isoconazole................................................................................ 2173Isoconazole nitrate .................................................................. 2175Isoelectric focusing (2.2.54) (5.8.) .................................6.6-5143Isoelectric focusing (2.2.54.)...........................................6.6-5052Isoflurane....................................................................................2176Isoleucine................................................................................... 2177Isomalt........................................................................................ 2178Isoniazid..................................................................................... 2180Isophane insulin injection.......................................................2141Isoprenaline hydrochloride.................................................... 2181Isoprenaline sulphate.............................................................. 2182Isopropyl alcohol...................................................................... 2182Isopropyl myristate.................................................................. 2183Isopropyl palmitate.................................................................. 2184Isosorbide dinitrate, diluted ................................................. 2185Isosorbide mononitrate, diluted .......................................... 2186Isotretinoin ................................................................................ 2188Isoxsuprine hydrochloride ..................................................... 2189Ispaghula husk ......................................................................... 2191Ispaghula seed .......................................................................... 2192Isradipine ................................................................................... 2192Itraconazole .......................................................................6.4-4645Ivermectin.................................................................................. 2196Ivy leaf ........................................................................................ 2198

JJavanese turmeric .................................................................... 3150Java tea ................................................................................6.4-4649Josamycin...................................................................................2204Josamycin propionate..............................................................2205Juniper........................................................................................2206Juniper oil ..................................................................................2207



KKanamycin acid sulphate ....................................................... 2211Kanamycin monosulphate...................................................... 2212Kaolin, heavy......................................................................6.3-4183Kelp ............................................................................................. 2213Ketamine hydrochloride ......................................................... 2214Ketobemidone hydrochloride................................................ 2215Ketoconazole ............................................................................ 2216Ketoprofen................................................................................. 2218Ketorolac trometamol .............................................................2220Ketotifen hydrogen fumarate ................................................ 2221Knotgrass...................................................................................2223Krypton (81mKr) inhalation gas..............................................1000

LLabetalol hydrochloride .........................................................2227Lactic acid..................................................................................2228Lactic acid, (S)- .........................................................................2229Lactitol monohydrate.......................................................6.5-4913Lactobionic acid ....................................................................... 2231Lactose, anhydrous...........................................................6.5-4914Lactose monohydrate.......................................................6.5-4916Lactulose.............................................................................6.3-4191Lactulose, liquid ................................................................6.3-4193Lamivudine................................................................................2238Lamotrigine........................................................................6.6-5273Lansoprazole......................................................................6.6-5274Laser light diffraction, particle size analysis by(2.9.31.) ............................................................................6.6-5103

Lauromacrogol 400 ..........................................................6.3-4196Lauroyl macrogolglycerides ..................................................2242Lavender flower........................................................................2243Lavender oil...............................................................................2244Lavender oil, spike............................................................6.5-4962Lead in sugars (2.4.10.) ............................................................ 115Leflunomide ..............................................................................2245Lemon oil ...................................................................................2246Lemon verbena leaf ..........................................................6.3-4199Leptospirosis vaccine (inactivated), bovine.......................... 876Leptospirosis vaccine (inactivated), canine .......................... 888Letrozole ....................................................................................2249Leucine.......................................................................................2250Leuprorelin................................................................................ 2251Levamisole for veterinary use ...............................................2253Levamisole hydrochloride ...............................................6.4-4653Levocabastine hydrochloride ................................................2255Levocarnitine ............................................................................2257Levodopa....................................................................................2258Levodropropizine ..............................................................6.3-4200Levomenthol ............................................................................. 2261Levomepromazine hydrochloride.........................................2262Levomepromazine maleate ....................................................2263Levomethadone hydrochloride ......................................6.5-4917Levonorgestrel ..........................................................................2266Levothyroxine sodium ............................................................2267Lidocaine ............................................................................6.1-3485Lidocaine hydrochloride.........................................................2269Light liquid paraffin ................................................................ 2612Light magnesium carbonate...........................................6.4-4661Light magnesium oxide ...................................................6.4-4663Lime flower ...............................................................................2270Limit tests (2.4.)...........................................................................111Limit tests, standard solutions for (4.1.2.)...................6.4-4535Lincomycin hydrochloride .....................................................2271Linen thread, sterile, in distributor for veterinary use ...1058Linoleoyl macrogolglycerides................................................2273Linseed .......................................................................................2273Linseed oil, virgin .............................................................6.6-5276

Liothyronine sodium........................................................6.4-4654Lipophilic solid dosage forms, dissolution test for(2.9.42.) ...................................................................................... 332

Liquid chromatography (2.2.29.) .............................................. 46Liquid extracts ...................................................................6.1-3343Liquid glucose ...................................................................6.2-3752Liquid glucose, spray-dried.............................................6.4-4629Liquid lactulose .................................................................6.3-4193Liquid maltitol ..........................................................................2332Liquid paraffin .......................................................................... 2613Liquid preparations for cutaneous application ................... 728Liquid preparations for cutaneous application,veterinary .................................................................................. 752

Liquid preparations for inhalation ......................................... 740Liquid preparations for oral use............................................. 728Liquids, clarity and degree of opalescence of (2.2.1.) ...........21Liquid sorbitol (crystallising) ................................................2942Liquid sorbitol (non-crystallising) ........................................2943Liquid sorbitol, partially dehydrated ............................6.3-4307Liquorice dry extract for flavouring purposes ...........6.1-3488Liquorice ethanolic liquid extract, standardised .......6.2-3775Liquorice root ....................................................................6.6-5276Lisinopril dihydrate .................................................................2277Lithium carbonate ...................................................................2279Lithium citrate..........................................................................2279L-Methionine ([11C]methyl) injection.................................... 1001Lobeline hydrochloride...........................................................2280Lomustine.................................................................................. 2281Loosestrife .................................................................................2283Loperamide hydrochloride.....................................................2283Loperamide oxide monohydrate...........................................2285Loratadine ..........................................................................6.6-5277Lorazepam.................................................................................2288Losartan potassium..........................................................6.4-4655Loss on drying (2.2.32.).............................................................. 53Loss on drying of extracts (2.8.17.) ........................................ 256Lovage root................................................................................2290Lovastatin ...........................................................................6.6-5279Low-molecular-mass heparins ............................................... 2041Lozenges and pastilles.............................................................. 734Lozenges, compressed .............................................................. 734Lubricant, silicone oil (3.1.8.).................................................. 358Lymecycline........................................................................6.1-3489Lynestrenol.........................................................................6.3-4202Lyophilisates, oral ...................................................................... 748Lysine acetate ...........................................................................2295Lysine hydrochloride...............................................................2296

MMacrogol 15 hydroxystearate ................................................2305Macrogol 20 glycerol monostearate ....................................2304Macrogol 40 sorbitol heptaoleate .................................6.3-4207Macrogol 6 glycerol caprylocaprate.....................................2302Macrogol cetostearyl ether .................................................... 2301Macrogolglycerol cocoates.....................................................2302Macrogolglycerol hydroxystearate .......................................2303Macrogolglycerol ricinoleate .................................................2304Macrogol lauryl ether .............................................................2306Macrogol oleate ........................................................................2307Macrogol oleyl ether ...............................................................2308Macrogols...................................................................................2308Macrogol stearate..................................................................... 2311Macrogol stearyl ether............................................................ 2312Magaldrate..........................................................................6.3-4207Magnesium (2.4.6.) .................................................................... 112Magnesium acetate tetrahydrate .......................................... 2313Magnesium aluminium silicate ......................................6.3-4024Magnesium and alkaline-earth metals (2.4.7.) ..................... 112Magnesium aspartate dihydrate ........................................... 2314



Magnesium carbonate, heavy .........................................6.5-4921Magnesium carbonate, light ...........................................6.4-4661Magnesium chloride 4.5-hydrate .......................................... 2317Magnesium chloride hexahydrate ........................................ 2316Magnesium citrate, anhydrous.......................................6.4-4661Magnesium citrate dodecahydrate ................................6.6-5285Magnesium citrate nonahydrate ....................................6.6-5285Magnesium gluconate......................................................6.1-3495Magnesium glycerophosphate............................................... 2318Magnesium hydroxide............................................................. 2319Magnesium lactate dihydrate ................................................2320Magnesium oxide, heavy..................................................6.4-4662Magnesium oxide, light....................................................6.4-4663Magnesium peroxide ............................................................... 2321Magnesium pidolate ................................................................2322Magnesium stearate..........................................................6.5-4921Magnesium sulphate heptahydrate......................................2325Magnesium trisilicate ..............................................................2325Maize oil, refined...............................................................6.6-5286Maize starch .......................................................................6.3-4212Malathion...................................................................................2327Maleic acid.................................................................................2328Malic acid ...................................................................................2329Mallow flower............................................................................2330Mallow leaf..........................................................................6.3-4212Maltitol ................................................................................6.3-4213Maltitol, liquid...........................................................................2332Maltodextrin.......................................................................6.5-4924Mandarin oil ..............................................................................2333Manganese gluconate ......................................................6.1-3495Manganese glycerophosphate, hydrated......................6.4-4664Manganese sulphate monohydrate ......................................2335Mannheimia vaccine (inactivated) for cattle ........................ 927Mannheimia vaccine (inactivated) for sheep........................ 928Mannitol ..............................................................................6.4-4665Maprotiline hydrochloride .....................................................2337Marbofloxacin for veterinary use ..................................6.1-3496Marek’s disease vaccine (live).................................................. 930Marshmallow leaf .....................................................................2338Marshmallow root ....................................................................2339Mass spectrometry (2.2.43.)....................................................... 68Mass spectrometry, inductively coupled plasma- (2.2.58.).. 98Mass uniformity of delivered doses from multidose containers(2.9.27.) ...................................................................................... 309

Mass uniformity of single-dose preparations (2.9.5.) ......... 278Mastic..........................................................................................2340Materials based on non-plasticised poly(vinyl chloride) forcontainers for dry dosage forms for oral administration(3.1.11.)..............................................................................6.4-4417

Materials based on non-plasticised poly(vinyl chloride)for containers for non-injectable, aqueous solutions(3.1.10.) ...................................................................................... 360

Materials based on plasticised poly(vinyl chloride) forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 366

Materials based on plasticised poly(vinyl chloride) forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 339

Materials based on plasticised poly(vinyl chloride) fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 342

Materials for containers for human blood and bloodcomponents (3.1.1.) ................................................................. 339

Materials used for the manufacture of containers (3.1.) ... 339Matricaria flower......................................................................2340Matricaria liquid extract ..................................................6.2-3780Matricaria oil .............................................................................2342Meadowsweet ............................................................................2344Measles immunoglobulin, human ........................................2069

Measles, mumps and rubella vaccine (live) .................6.1-3347Measles, mumps, rubella and varicella vaccine (live)..6.6-5178Measles vaccine (live) .......................................................6.1-3348Measurement of consistency by penetrometry(2.9.9.) ...............................................................................6.2-3641

Mebendazole .............................................................................2345Meclozine hydrochloride........................................................2346Medicated chewing gum, dissolution test for (2.9.25.) ...... 304Medicated chewing gums ......................................................... 719Medicated feeding stuffs for veterinary use, premixes for.. 739Medicated foams......................................................................... 723Medicated plasters ............................................................6.3-3980Medicated tampons.................................................................... 751Medicated vaginal tampons ..................................................... 752Medicinal air.......................................................................6.3-4020Medicinal air, synthetic........................................................... 1121Medium-chain triglycerides.............................................6.6-5348Medronic acid for radiopharmaceutical preparations........6.5-4823

Medroxyprogesterone acetate ...............................................2347Mefenamic acid ..................................................................6.6-5286Mefloquine hydrochloride......................................................2350Megestrol acetate .....................................................................2352Meglumine.................................................................................2353Melilot.........................................................................................2354Melissa leaf .........................................................................6.4-4668Melissa leaf dry extract ....................................................6.6-5288Meloxicam...........................................................................6.3-4218Melting point - capillary method (2.2.14.)............................... 32Melting point - instantaneous method (2.2.16.) .................... 33Melting point - open capillary method (2.2.15.) .................... 32Menadione .................................................................................2356Meningococcal group C conjugate vaccine...........................814Meningococcal polysaccharide vaccine..................................816Menthol, racemic......................................................................2356Mepivacaine hydrochloride....................................................2357Meprobamate ............................................................................2359Mepyramine maleate ...............................................................2360Mercaptopurine ........................................................................ 2361Mercuric chloride..................................................................... 2361Mercury porosimetry, porosity and pore-size distribution ofsolids by (2.9.32.) ............................................................6.2-3643

Mesalazine .................................................................................2362Mesna..........................................................................................2364Mesterolone...............................................................................2366Mestranol ...................................................................................2367Metacresol .................................................................................2368Metamizole sodium .................................................................2369Metformin hydrochloride .......................................................2370Methacrylate copolymer, basic butylated ...........................1254Methacrylic acid - ethyl acrylate copolymer (1:1) ......6.2-3781Methacrylic acid - ethyl acrylate copolymer (1:1) dispersion30 per cent .......................................................................6.3-4220

Methacrylic acid - methyl methacrylate copolymer (1:1) ..2373Methacrylic acid - methyl methacrylate copolymer (1:2) .. 2374Methadone hydrochloride...................................................... 2374Methanol ....................................................................................2376Methanol and 2-propanol, test for (2.9.11.) .......................... 282Methaqualone ...........................................................................2377Methenamine ............................................................................2378Methionine ................................................................................2379Methionine ([11C]methyl) injection, L-.................................. 1001Methionine, DL- .........................................................................2380Methods in pharmacognosy (2.8.) .......................................... 249Methods of preparation of homoeopathic stocks andpotentisation....................................................................6.1-3385

Methods of preparation of sterile products (5.1.1.) ............ 525Methotrexate ......................................................................6.3-4220Methylatropine bromide .........................................................2383



Methylatropine nitrate ............................................................2383Methylcellulose..................................................................6.3-4223Methyldopa.........................................................................6.5-4925Methylene blue .........................................................................2402Methylene chloride ..................................................................2387Methylergometrine maleate............................................6.5-4926Methylhydroxyethylcellulose .................................................2390Methyl nicotinate .....................................................................2390Methyl parahydroxybenzoate ................................................ 2391Methylpentoses in polysaccharide vaccines (2.5.21.) ......... 143Methylphenidate hydrochloride.....................................6.6-5289Methylphenobarbital ...............................................................2392Methylprednisolone.................................................................2393Methylprednisolone acetate...................................................2395Methylprednisolone hydrogen succinate ............................2397Methylpyrrolidone, N- .............................................................2399Methylrosanilinium chloride .................................................2400Methyl salicylate....................................................................... 2401Methyltestosterone ...........................................................6.3-4226Methylthioninium chloride ....................................................2402Metixene hydrochloride ..........................................................2404Metoclopramide.................................................................6.2-3783Metoclopramide hydrochloride.............................................2407Metolazone ................................................................................2407Metoprolol succinate...............................................................2409Metoprolol tartrate .................................................................. 2410Metrifonate ................................................................................ 2412Metronidazole ........................................................................... 2414Metronidazole benzoate ......................................................... 2415Mexiletine hydrochloride........................................................ 2416Mianserin hydrochloride .................................................6.3-4227Miconazole ................................................................................ 2418Miconazole nitrate ...................................................................2420Microbial enumeration tests (microbiological examination ofnon-sterile products) (2.6.12.) ......................................6.5-4769

Microbiological assay of antibiotics (2.7.2.).................6.3-3935Microbiological control of cellular products (2.6.27.) ........ 205Microbiological examination of non-sterile products :microbial enumeration tests (2.6.12.).........................6.5-4769

Microbiological examination of non-sterile products : test forspecified micro-organisms (2.6.13.) ............................6.5-4773

Microbiological quality, alternative methods for control of(5.1.6.)......................................................................................... 532

Microbiological quality of non-sterile pharmaceuticalpreparations and substances for pharmaceutical use(5.1.4.)................................................................................6.3-3957

Microbiology, general texts on (5.1.) ..................................... 525Microcrystalline cellulose................................................6.3-4080Microcrystalline cellulose and carmellose sodium...........2422Micro determination of water (2.5.32.).................................. 147Microscopy, optical (2.9.37) (5.8.) .................................6.6-5144Microscopy, optical (2.9.37.) ...........................................6.6-5110Midazolam .................................................................................2422Milk thistle dry extract, refined and standardised............2426Milk-thistle fruit........................................................................2425Minimising the risk of transmitting animal spongiformencephalopathy agents via human and veterinary medicinalproducts (5.2.8.) ....................................................................... 558

Minocycline hydrochloride dihydrate ..................................2427Minoxidil ....................................................................................2429Mint oil, partly dementholised ..............................................2430Mirtazapine ........................................................................6.5-4927Misoprostol................................................................................2433Mitomycin ..................................................................................2434Mitoxantrone hydrochloride..................................................2436Modafinil ....................................................................................2437Modified-release capsules......................................................... 718Modified-release granules ........................................................ 724Modified-release tablets ............................................................ 750

Molecular mass distribution in dextrans (2.2.39.) ................ 60Molgramostim concentrated solution .................................2438Molsidomine.......................................................................6.5-4929Mometasone furoate................................................................ 2441Monoclonal antibodies for human use.................................. 690Morantel hydrogen tartrate for veterinary use .................2443Morphine hydrochloride..................................................6.1-3501Morphine sulphate............................................................6.2-3785Moss, Iceland ............................................................................ 2121Mother tinctures for homoeopathic preparations ............1072Motherwort ...............................................................................2447Mouthwashes .............................................................................. 733Moxidectin for veterinary use ........................................6.5-4931Moxifloxacin hydrochloride ............................................6.2-3786Moxonidine................................................................................2453Mucoadhesive preparations ..................................................... 735Mullein flower...........................................................................2454Multidose containers, uniformity of mass of delivered doses(2.9.27.) ...................................................................................... 309

Mumps, measles and rubella vaccine (live) .................6.1-3347Mumps, measles, rubella and varicella vaccine (live)..6.6-5178Mumps vaccine (live) ........................................................6.1-3349Mupirocin...................................................................................2454Mupirocin calcium ...................................................................2456Mycobacteria (2.6.2.) ................................................................. 159Mycophenolate mofetil............................................................2458Mycoplasma gallisepticum vaccine (inactivated)................. 932Mycoplasmas (2.6.7.).........................................................6.1-3317myo-Inositol ..............................................................................2460Myrrh .......................................................................................... 2461Myrrh tincture .......................................................................... 2461Myxomatosis vaccine (live) for rabbits .................................. 933

NNabumetone ..............................................................................2465N-Acetyltryptophan...........................................................6.3-4016N-Acetyltyrosine ....................................................................... 1106Nadolol .......................................................................................2466Nadroparin calcium .................................................................2467Naftidrofuryl hydrogen oxalate.............................................2470Nalidixic acid.............................................................................2472Naloxone hydrochloride dihydrate.......................................2473Naltrexone hydrochloride....................................................... 2474Nandrolone decanoate ............................................................2476Naphazoline hydrochloride.............................................6.3-4235Naphazoline nitrate .................................................................2479Naproxen.............................................................................6.2-3791Naproxen sodium ..............................................................6.1-3507Narrow-leaved coneflower root .............................................2483Nasal drops and liquid nasal sprays....................................... 731Nasal powders............................................................................. 732Nasal preparations ..................................................................... 730Nasal preparations, semi-solid................................................. 732Nasal sprays (liquid) and nasal drops .................................... 730Nasal sticks.................................................................................. 732Nasal washes ............................................................................... 732Near-infrared spectrophotometry (2.2.40.)............................. 62Neohesperidin-dihydrochalcone ...........................................2485Neomycin sulphate ..................................................................2487Neonatal piglet colibacillosis vaccine (inactivated) ............ 934Neonatal ruminant colibacillosis vaccine (inactivated) ..... 936Neostigmine bromide ..............................................................2489Neostigmine metilsulfate........................................................2490Neroli oil ....................................................................................2490Netilmicin sulphate..................................................................2492Nettle leaf...................................................................................2493Neurovirulence test for poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 193

Neurovirulence test of live viral vaccines (2.6.18.) ............. 193



Nevirapine, anhydrous............................................................2495Newcastle disease vaccine (inactivated) ................................ 937Newcastle disease vaccine (live).............................................. 939Nicergoline ................................................................................2496Nickel in hydrogenated vegetable oils (2.4.31.)....................131Nickel in polyols (2.4.15.) ..........................................................116Niclosamide, anhydrous .........................................................2497Niclosamide monohydrate .....................................................2498Nicotinamide .............................................................................2499Nicotine ...............................................................................6.6-5293Nicotine resinate ...............................................................6.6-5294Nicotinic acid ............................................................................2502Nifedipine...................................................................................2503Niflumic acid ......................................................................6.1-3508Nifuroxazide .......................................................................6.1-3510Nikethamide ..............................................................................2505Nilutamide ..........................................................................6.2-3792Nimesulide.................................................................................2506Nimodipine ................................................................................2507Nitrazepam ................................................................................2508Nitrendipine ..............................................................................2509Nitric acid .................................................................................. 2510Nitric oxide .........................................................................6.2-3794Nitrofural ................................................................................... 2512Nitrofurantoin........................................................................... 2513Nitrogen ..............................................................................6.2-3795Nitrogen determination by sulphuric acid digestion(2.5.9.) ........................................................................................ 139

Nitrogen determination, primary aromatic amino(2.5.8.) ........................................................................................ 139

Nitrogen, low-oxygen............................................................... 2514Nitrogen monoxide and nitrogen dioxide in gases(2.5.26.) ...................................................................................... 146

Nitrous oxide............................................................................. 2515Nitrous oxide in gases (2.5.35.)............................................... 152Nizatidine................................................................................... 2516N-Methylpyrrolidone................................................................2399NMR spectrometry (2.2.33.)............................................6.3-3909N,N-Dimethylaniline (2.4.26.) .................................................. 127Nomegestrol acetate................................................................ 2518Nonoxinol 9............................................................................... 2519Non-sterile products, microbiological examination of(microbial enumeration tests) (2.6.12.) ......................6.5-4769

Non-sterile products, microbiological examination of (test forspecified micro-organisms) (2.6.13.) ...........................6.5-4773

Noradrenaline hydrochloride ................................................2520Noradrenaline tartrate ............................................................ 2521Norcholesterol injection, iodinated (131I) ............................1003Norepinephrine hydrochloride..............................................2520Norepinephrine tartrate ......................................................... 2521Norethisterone..........................................................................2523Norethisterone acetate ...........................................................2524Norfloxacin.........................................................................6.2-3796Norgestimate .............................................................................2526Norgestrel ..................................................................................2527Normal immunoglobulin for intravenous administration,human ...............................................................................6.6-5268

Normal immunoglobulin, human..................................6.6-5266Nortriptyline hydrochloride............................................6.6-5295Noscapine ..................................................................................2529Noscapine hydrochloride........................................................2530Notoginseng root ..................................................................... 2531Nuclearmagnetic resonance spectrometry (2.2.33.) ..6.3-3909Nucleated cell count and viability (2.7.29.) .......................... 243Nucleic acid amplification techniques (2.6.21.) ................... 195Nucleic acids in polysaccharide vaccines (2.5.17.) .............. 142Numeration of CD34/CD45+ cells in haematopoieticproducts (2.7.23.) ..................................................................... 238

Nutmeg oil ..........................................................................6.2-3797

Nystatin ......................................................................................2534

OO-Acetyl in polysaccharide vaccines (2.5.19.) ...................... 143Oak bark ....................................................................................2539Octoxinol 10 ..............................................................................2539Octyldodecanol .........................................................................2540Octyl gallate ..............................................................................2539Odour (2.3.4.).............................................................................. 107Odour and taste of essential oils (2.8.8.) .............................. 250Ofloxacin.............................................................................6.2-3801Oils, essential .............................................................................. 680Oils, fatty, identification by thin-layer chromatography(2.3.2.) ...............................................................................6.6-5067

Oils, fatty, vegetable .........................................................6.4-4553Oils rich in omega-3 acids, composition of fatty acids in(2.4.29.) .............................................................................6.6-5073

Oils rich in omega-3 acids, total cholesterol in (2.4.32.) ... 132Ointments ...........................................................................6.3-3980Oleic acid ...................................................................................2543Oleoresins ...........................................................................6.1-3344Oleoyl macrogolglycerides.....................................................2543Oleyl alcohol .............................................................................2544Olive leaf .............................................................................6.3-4241Olive leaf dry extract ........................................................6.4-4673Olive oil, refined ................................................................6.6-5301Olive oil, virgin ..................................................................6.6-5302Olsalazine sodium....................................................................2548Omega-3-acid ethyl esters 60..........................................6.3-4242Omega-3-acid ethyl esters 90..........................................6.3-4244Omega-3 acids, composition of fatty acids in oils rich in(2.4.29.) .............................................................................6.6-5073

Omega-3 acids, fish oil rich in ...............................................1893Omega-3 acids, total cholesterol in oils rich in (2.4.32.) ... 132Omega-3-acid triglycerides ..............................................6.3-4246Omeprazole ...............................................................................2557Omeprazole magnesium..................................................6.3-4248Omeprazole sodium.................................................................2558Ondansetron hydrochloride dihydrate ................................2560Opalescence of liquids, clarity and degree of (2.2.1.)............21Ophthalmic inserts .................................................................... 722Opium dry extract, standardised ..........................................2562Opium, prepared.......................................................................2563Opium, raw ................................................................................2564Opium tincture, standardised................................................2565Optical microscopy (2.9.37) (5.8.)..................................6.6-5144Optical microscopy (2.9.37.) ...........................................6.6-5110Optical rotation (2.2.7.)............................................................... 26Oral drops .................................................................................... 730Oral lyophilisates........................................................................ 748Oral powders............................................................................... 738Oral solutions, emulsions and suspensions ......................... 729Oral use, liquid preparations for............................................. 728Orbifloxacin for veterinary use ......................................6.6-5302Orciprenaline sulphate.....................................................6.2-3804Oregano......................................................................................2568Organ preservation, solutions for.........................................2929Oriental cashew for homoeopathic preparations..............1082Orodispersible tablets ............................................................... 750Oromucosal capsules ................................................................ 734Oromucosal drops, oromucosal sprays and sublingualsprays.......................................................................................... 733

Oromucosal preparations......................................................... 732Oromucosal preparations, semi-solid..................................... 733Oromucosal solutions and oromucosal suspensions ......... 733Oromucosal sprays, oromucosal drops and sublingualsprays.......................................................................................... 732

Oromucosal suspensions and oromucosal solutions ......... 732Orphenadrine citrate...............................................................2569



Orphenadrine hydrochloride.................................................2570Osmolality (2.2.35.)...................................................................... 57Ouabain......................................................................................2571Oxacillin sodium monohydrate ......................................6.2-3806Oxaliplatin ..........................................................................6.3-4249Oxazepam ..................................................................................2577Oxeladin hydrogen citrate......................................................2578Oxfendazole for veterinary use......................................6.2-3808Oxidising substances (2.5.30.)................................................. 147Oxitropium bromide ................................................................ 2581Oxolinic acid.......................................................................6.5-4937Oxprenolol hydrochloride ......................................................2583Oxybuprocaine hydrochloride...............................................2584Oxybutynin hydrochloride .....................................................2585Oxycodone hydrochloride ......................................................2587Oxygen (15O) ..............................................................................1004Oxygen.................................................................................6.6-5304Oxygen-flask method (2.5.10.)................................................. 140Oxygen in gases (2.5.27.).................................................6.3-3916Oxymetazoline hydrochloride ........................................6.3-4252Oxytetracycline dihydrate ......................................................2590Oxytetracycline hydrochloride .............................................. 2591Oxytocin .....................................................................................2593Oxytocin concentrated solution............................................2594

PPaclitaxel.............................................................................6.3-4257Pale coneflower root ...............................................................2602Palmitic acid..............................................................................2604Pamidronate disodium pentahydrate ..................................2604Pancreas powder ...............................................................6.3-4260Pancuronium bromide ............................................................2608Pansy, wild (flowering aerial parts) ..................................... 3217Pantoprazole sodium sesquihydrate.............................6.1-3518Papaverine hydrochloride ......................................................2609Paper chromatography (2.2.26.) ............................................... 43Paracetamol .............................................................................. 2611Paraffin, hard ............................................................................ 2612Paraffin, light liquid ................................................................ 2612Paraffin, liquid .......................................................................... 2613Paraffin, white soft ...........................................................6.5-4941Paraffin, yellow soft..........................................................6.2-3816Parainfluenza virus vaccine (live), bovine............................ 878Parainfluenza virus vaccine (live), canine ............................ 890Paraldehyde............................................................................... 2615Paramyxovirus 1 (Newcastle disease) vaccine (inactivated),avian ........................................................................................... 937

Parenteral preparations............................................................ 735Parenteral preparations, test for extractable volume of(2.9.17.)....................................................................................... 287

Parnaparin sodium .................................................................. 2616Paroxetine hydrochloride, anhydrous ................................. 2616Paroxetine hydrochloride hemihydrate............................... 2619Particles, fine, aerodynamic assessment of in preparationsfor inhalation (2.9.18.) ............................................................ 287

Particle size analysis by laser light diffraction(2.9.31.) .............................................................................6.6-5103

Particle-size distribution estimation by analytical sieving(2.9.38) (5.8.)....................................................................6.6-5145

Particle-size distribution estimation by analytical sieving(2.9.38.) .............................................................................6.6-5112

Particulate contamination : sub-visible particles (2.9.19.).. 300Particulate contamination : visible particles (2.9.20.) ........ 302Parvovirosis vaccine (inactivated), canine ............................ 891Parvovirosis vaccine (inactivated), porcine .......................... 946Parvovirosis vaccine (live), canine.......................................... 892Passion flower .......................................................................... 2621Passion flower dry extract .....................................................2622Pastes...................................................................................6.3-3980

Pasteurella vaccine (inactivated) for sheep .......................... 941Pastilles and lozenges............................................................... 734Patches, transdermal................................................................. 737Patches, transdermal, dissolution test for (2.9.4.) .............. 275Pea starch ...........................................................................6.3-4263Pefloxacin mesilate dihydrate ...............................................2623Pelargonium root .....................................................................2625Penbutolol sulphate ................................................................2625Penetrometry, measurement of consistency by(2.9.9.) ...............................................................................6.2-3641

Penicillamine......................................................................6.5-4941Pentaerythrityl tetranitrate, diluted .............................6.5-4943Pentamidine diisetionate........................................................2630Pentazocine............................................................................... 2631Pentazocine hydrochloride ....................................................2632Pentazocine lactate .................................................................2632Pentetate sodium calcium for radiopharmaceuticalpreparations.....................................................................6.3-4001

Pentobarbital ............................................................................2633Pentobarbital sodium..............................................................2634Pentoxifylline ............................................................................2635Pentoxyverine hydrogen citrate............................................2637Peppermint leaf .................................................................6.6-5309Peppermint leaf dry extract ............................................6.4-4677Peppermint oil ..........................................................................2639Pepsin powder ...................................................................6.3-4263Peptide mapping (2.2.55) (5.8.)......................................6.6-5143Peptide mapping (2.2.55.) ...............................................6.6-5054Peptides, synthetic, acetic acid in (2.5.34.)........................... 151Pergolide mesilate.................................................................... 2641Perindopril tert-butylamine....................................................2643Peritoneal dialysis, solutions for...........................................2646Peroxide value (2.5.5.)............................................................... 138Perphenazine .....................................................................6.3-4265Pertussis (acellular, component), diphtheria and tetanusvaccine (adsorbed)................................................................... 767

Pertussis (acellular, component), diphtheria, tetanus andhaemophilus type b conjugate vaccine (adsorbed) .......... 771

Pertussis (acellular, component), diphtheria, tetanus andhepatitis B (rDNA) vaccine (adsorbed) ............................... 774

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed) .................. 775

Pertussis (acellular, component), diphtheria, tetanus andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) .................................................................. 778

Pertussis (acellular, component), diphtheria, tetanus,hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 780

Pertussis (acellular, component), diphtheria, tetanus,poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed).......................................6.3-3983

Pertussis, diphtheria, tetanus and poliomyelitis (inactivated)vaccine (adsorbed)................................................................... 785

Pertussis, diphtheria, tetanus, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 787

Pertussis vaccine (acellular), assay of (2.7.16.).................... 233Pertussis vaccine (acellular, component, adsorbed) .......... 820Pertussis vaccine (acellular, co-purified, adsorbed) ........... 822Pertussis vaccine (adsorbed) ................................................... 824Pertussis vaccine, assay of (2.7.7.) .......................................... 222Pertussis vaccine (whole cell, adsorbed)......................6.6-5179Peru balsam........................................................................6.2-3817Pessaries....................................................................................... 751Pessaries and suppositories, disintegration of (2.9.2.) ...... 265Pesticide residues (2.8.13.)..............................................6.2-3637Pethidine hydrochloride.........................................................2650Pharmaceutical technical procedures (2.9.)......................... 263Pharmacognosy, methods in (2.8.)......................................... 249Pharmacopoeial harmonisation (5.8.) ..........................6.6-5143



Phenazone..........................................................................6.6-5310Pheniramine maleate ..............................................................2652Phenobarbital ...........................................................................2653Phenobarbital sodium.............................................................2654Phenol .................................................................................6.3-4266Phenol in immunosera and vaccines (2.5.15.) ..................... 142Phenolphthalein.......................................................................2656Phenolsulfonphthalein ...........................................................2657Phenothiazines, identification by thin-layer chromatography(2.3.3.) ........................................................................................ 107

Phenoxyethanol........................................................................2657Phenoxymethylpenicillin .................................................6.1-3520Phenoxymethylpenicillin potassium.............................6.1-3521Phentolamine mesilate ...........................................................2662Phenylalanine ...........................................................................2663Phenylbutazone .......................................................................2664Phenylephrine...........................................................................2665Phenylephrine hydrochloride................................................2667Phenylmercuric acetate ..........................................................2668Phenylmercuric borate ...........................................................2669Phenylmercuric nitrate ...........................................................2669Phenylpropanolamine hydrochloride ..................................2670Phenytoin............................................................................6.4-4677Phenytoin sodium.............................................................6.4-4679Phloroglucinol, anhydrous ....................................................2672Phloroglucinol dihydrate .......................................................2673Pholcodine..........................................................................6.3-4266Phosphates (2.4.11.) ...................................................................116Phosphoric acid, concentrated .............................................2675Phosphoric acid, dilute ...........................................................2676Phosphorus in polysaccharide vaccines (2.5.18.) ............... 142pH, potentiometric determination of (2.2.3.) ......................... 24Phthalylsulfathiazole ..............................................................2676Physical and physicochemical methods (2.2.) ........................21Physostigmine salicylate.........................................................2677Physostigmine sulphate..........................................................2678Phytomenadione ......................................................................2679Phytosterol ................................................................................2680Picotamide monohydrate .......................................................2682Pilocarpine hydrochloride...............................................6.3-4268Pilocarpine nitrate ............................................................6.3-4269Pimobendan ..............................................................................2685Pimozide ....................................................................................2686Pindolol ......................................................................................2688Pine (dwarf) oil ......................................................................... 1766Pine sylvestris oil .....................................................................2689Pinus pinaster type turpentine oil ....................................... 3151Pipemidic acid trihydrate .......................................................2690Piperacillin ................................................................................ 2691Piperacillin sodium..................................................................2692Piperazine adipate ...................................................................2694Piperazine citrate..............................................................6.5-4945Piperazine hydrate...................................................................2696Piracetam...................................................................................2697Pirenzepine dihydrochloride monohydrate .......................2698Piretanide ..................................................................................2699Piroxicam ...................................................................................2700Pivampicillin..............................................................................2702Pivmecillinam hydrochloride.................................................2704Plasma for fractionation, human...................................6.2-3759Plasma (pooled and treated for virus inactivation),human ...............................................................................6.3-4168

Plasmid vectors for human use, bacterial cells used for themanufacture of ................................................................6.6-5152

Plasmin inhibitor, assay of human (2.7.25.) ................6.5-4786Plasters, medicated...........................................................6.3-3979Plastic additives (3.1.13.).................................................6.2-3655Plastic containers and closures for pharmaceutical use(3.2.2.) ........................................................................................ 378

Plastic containers for aqueous solutions for infusion(3.2.2.1.) ..................................................................................... 379

Plastic containers for human blood and blood components,sterile (3.2.3.) ............................................................................ 379

Plastic syringes, single-use, sterile (3.2.8.) ........................... 384Pneumococcal polysaccharide conjugate vaccine(adsorbed).................................................................................. 825

Pneumococcal polysaccharide vaccine ................................. 827Pneumonia vaccine (inactivated), porcine enzootic ..6.5-4818Poliomyelitis (inactivated), diphtheria and tetanus vaccine(adsorbed, reduced antigen(s) content) .............................. 770

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed) ........................ 775

Poliomyelitis (inactivated), diphtheria, tetanus and pertussis(acellular, component) vaccine (adsorbed, reducedantigen(s) content) .................................................................. 778

Poliomyelitis (inactivated), diphtheria, tetanus and pertussisvaccine (adsorbed)................................................................... 785

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component) and haemophilus type b conjugatevaccine (adsorbed)..........................................................6.3-3983

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis(acellular, component), hepatitis B (rDNA) and haemophilustype b conjugate vaccine (adsorbed) ................................... 780

Poliomyelitis (inactivated), diphtheria, tetanus, pertussis andhaemophilus type b conjugate vaccine (adsorbed) .......... 787

Poliomyelitis vaccine (inactivated) ................................6.3-3988Poliomyelitis vaccine (inactivated), in vivo assay of(2.7.20.) ...................................................................................... 235

Poliomyelitis vaccine (oral) .............................................6.1-3351Poliomyelitis vaccine (oral), test for neurovirulence(2.6.19.) ...................................................................................... 193

Poloxamers ................................................................................2705Polyacrylate dispersion 30 per cent..............................6.3-4270Polyamide 6/6 suture, sterile, in distributor for veterinaryuse ............................................................................................1059

Polyamide 6 suture, sterile, in distributor for veterinary use...................................................................................................1058

Polyethyleneglycols .................................................................2308Polyethylene terephthalate for containers for preparationsnot for parenteral use (3.1.15.) ............................................. 369

Poly(ethylene terephthalate) suture, sterile, in distributor forveterinary use ........................................................................1059

Poly(ethylene - vinyl acetate) for containers and tubing fortotal parenteral nutrition preparations (3.1.7.) ................. 356

Polyethylene with additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.5.) ... 349

Polyethylene without additives for containers for parenteralpreparations and for ophthalmic preparations (3.1.4.) ... 348

Polymorphism (5.9.) .................................................................. 649Polymyxin B sulphate .............................................................2707Polyolefines (3.1.3.) ................................................................... 344Polyoxyl castor oil....................................................................2304Polyoxyl hydrogenated castor oil .........................................2303Polypropylene for containers and closures for parenteralpreparations and ophthalmic preparations (3.1.6.).......... 352

Polysaccharide vaccines, hexosamines in (2.5.20.)............. 143Polysaccharide vaccines, methylpentoses in (2.5.21.)........ 143Polysaccharide vaccines, nucleic acids in (2.5.17.) ............. 142Polysaccharide vaccines, O-acetyl in (2.5.19.)...................... 143Polysaccharide vaccines, phosphorus in (2.5.18.)............... 142Polysaccharide vaccines, protein in (2.5.16.) ....................... 142Polysaccharide vaccines, ribose in (2.5.31.) ......................... 147Polysaccharide vaccines, sialic acid in (2.5.23.) .................. 144Polysaccharide vaccines, uronic acids in (2.5.22.) .............. 144Polysorbate 20 ...................................................................6.3-4271Polysorbate 40 ...................................................................6.3-4272Polysorbate 60 ...................................................................6.3-4273Polysorbate 80 ...................................................................6.6-5311



Poly(vinyl acetate)....................................................................2712Poly(vinyl acetate) dispersion 30 per cent ..................6.6-5313Poly(vinyl alcohol) ................................................................... 2715Poly(vinyl chloride), non-plasticised, materials based on forcontainers for dry dosage forms for oral administration(3.1.11.)..............................................................................6.4-4417

Poly(vinyl chloride), non-plasticised, materials based onfor containers for non-injectable aqueous solutions(3.1.10.) ...................................................................................... 360

Poly(vinyl chloride), plasticised, empty sterile containers offor human blood and blood components (3.2.4.) ............. 381

Poly(vinyl chloride), plasticised, materials based on forcontainers for aqueous solutions for intravenous infusion(3.1.14.) ...................................................................................... 366

Poly(vinyl chloride), plasticised, materials based on forcontainers for human blood and blood components(3.1.1.1.) ..................................................................................... 339

Poly(vinyl chloride), plasticised, materials based on fortubing used in sets for the transfusion of blood and bloodcomponents (3.1.1.2.).............................................................. 342

Poly(vinyl chloride), plasticised, sterile containers offor human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 382

Poppy petals, red...............................................................6.5-4955Porcine actinobacillosis vaccine (inactivated) ..................... 943Porcine enzootic pneumonia vaccine (inactivated) ...6.5-4818Porcine influenza vaccine (inactivated) ................................ 944Porcine insulin.......................................................................... 2144Porcine parvovirosis vaccine (inactivated) ........................... 946Porcine progressive atrophic rhinitis vaccine(inactivated) .....................................................................6.1-3373

Pore-size distribution of solids by mercury porosimetry,porosity and (2.9.32.) .....................................................6.2-3643

Porosimetry, mercury, porosity and pore-size distribution ofsolids by (2.9.32.) ............................................................6.2-3643

Porosity and pore-size distribution of solids by mercuryporosimetry (2.9.32.)......................................................6.2-3643

Porosity of sintered-glass filters (2.1.2.) ...................................15Porous solids including powders, wettability of(2.9.45.) .............................................................................6.5-4791

Potassium (2.4.12.) .....................................................................116Potassium acetate .................................................................... 2716Potassium bromide .................................................................. 2716Potassium carbonate............................................................... 2717Potassium chloride ...........................................................6.2-3819Potassium citrate ..............................................................6.3-4276Potassium clavulanate .....................................................6.6-5314Potassium clavulanate, diluted ......................................6.6-5316Potassium dihydrogen phosphate .................................6.3-4277Potassium hydrogen aspartate hemihydrate .....................2723Potassium hydrogen carbonate ............................................2724Potassium hydrogen tartrate.................................................2725Potassium hydroxide ...............................................................2726Potassium iodide......................................................................2726Potassium metabisulphite......................................................2727Potassium nitrate .....................................................................2728Potassium perchlorate ............................................................2728Potassium permanganate.......................................................2729Potassium sodium tartrate tetrahydrate.............................2729Potassium sorbate....................................................................2730Potassium sulphate ................................................................. 2731Potato starch......................................................................6.3-4277Potentiometric determination of ionic concentration usingion-selective electrodes (2.2.36.)............................................. 58

Potentiometric determination of pH (2.2.3.).......................... 24Potentiometric titration (2.2.20.).............................................. 35Potentisation, methods of preparation of homoeopathicstocks and.........................................................................6.1-3385

Poultices..............................................................................6.3-3980

Pour-on preparations ................................................................ 753Povidone .............................................................................6.5-4948Povidone, iodinated.................................................................2734Powdered cellulose ...........................................................6.3-4084Powder fineness (2.9.35.) ................................................6.2-3648Powder flow (2.9.36) (5.8.)..............................................6.6-5144Powder flow (2.9.36.) .......................................................6.6-5107Powders and granules for oral solutions andsuspensions............................................................................... 729

Powders and granules for syrups ........................................... 730Powders and tablets for rectal solutions and suspensions.. 746Powders, bulk density and tapped density of(2.9.34.) .............................................................................6.5-4789

Powders, ear................................................................................ 720Powders, effervescent................................................................ 739Powders for cutaneous application...............................6.3-3978Powders for eye drops and powders for eye lotions........... 722Powders for inhalation.............................................................. 742Powders for injections or infusions ....................................... 736Powders for oral drops.............................................................. 730Powders, nasal ............................................................................ 732Powders, oral .............................................................................. 738Powders, wettability of porous solids including(2.9.45.) .............................................................................6.5-4791

Poxvirus vectors for human use ....................................6.6-5154Pravastatin sodium...........................................................6.6-5318Prazepam...................................................................................2736Praziquantel ..............................................................................2737Prazosin hydrochloride ..........................................................2738Prednicarbate............................................................................ 2740Prednisolone ............................................................................. 2741Prednisolone acetate............................................................... 2742Prednisolone pivalate.............................................................. 2744Prednisolone sodium phosphate .......................................... 2745Prednisone................................................................................. 2746Pregelatinised starch........................................................6.6-5335Prekallikrein activator (2.6.15.) .............................................. 189Premixes for medicated feeding stuffs for veterinary use.. 739Preparations for inhalation...................................................... 739Preparations for inhalation : aerodynamic assessment of fineparticles (2.9.18.) ..................................................................... 287

Preparations for irrigation....................................................... 743Pressurised pharmaceutical preparations ............................ 744Prilocaine................................................................................... 2748Prilocaine hydrochloride........................................................2750Primaquine diphosphate ........................................................ 2751Primary aromatic amino-nitrogen, determination of(2.5.8.) ........................................................................................ 139

Primary standards for volumetric solutions (4.2.1.) ..6.4-4545Primidone ..................................................................................2752Primula root ..............................................................................2753Probenecid.................................................................................2754Procainamide hydrochloride .................................................2755Procaine benzylpenicillin .......................................................1287Procaine hydrochloride ..........................................................2756Prochlorperazine maleate ......................................................2756Products of fermentation ......................................................... 693Products of recombinant DNA technology .......................... 701Products with risk of transmitting agents of animalspongiform encephalopathies............................................... 694

Progenitor cells, human haematopoietic, colony-forming cellassay for (2.7.28.) ..................................................................... 242

Progesterone .............................................................................2757Progressive atrophic rhinitis vaccine (inactivated),porcine ..............................................................................6.1-3373

Proguanil hydrochloride ........................................................2758Proline ........................................................................................2760Promazine hydrochloride....................................................... 2761Promethazine hydrochloride................................................. 2761



Propacetamol hydrochloride .................................................2763Propafenone hydrochloride ...................................................2764Propanol.....................................................................................2766Propanol and methanol, 2-, test for (2.9.11.) ....................... 282Propantheline bromide...........................................................2767Propofol......................................................................................2768Propranolol hydrochloride.....................................................2770Propylene glycol.......................................................................2773Propylene glycol dicaprylocaprate....................................... 2774Propylene glycol dilaurate ..................................................... 2774Propylene glycol monolaurate ..............................................2775Propylene glycol monopalmitostearate...............................2776Propylene glycol monostearate.............................................2776Propyl gallate ............................................................................2771Propyl parahydroxybenzoate.................................................2772Propylthiouracil .......................................................................2777Propyphenazone ......................................................................2778Protamine hydrochloride .......................................................2779Protamine sulphate .................................................................2780Protein C, human, assay of (2.7.30.) .............................6.2-3631Protein in polysaccharide vaccines (2.5.16.) ........................ 142Protein S, human, assay of (2.7.31.)..............................6.2-3632Protein, total (2.5.33.) ............................................................... 148Prothrombin complex, human ..............................................2076Protirelin .................................................................................... 2781Proxyphylline ............................................................................2783Pseudoephedrine hydrochloride ...................................6.2-3820Psyllium seed ............................................................................2785Purified water ....................................................................6.3-4344Purified water, highly ......................................................6.3-4342Purple coneflower herb..........................................................2785Purple coneflower root...........................................................2787Pycnometric density of solids, gas (2.9.23.) ................6.2-3642Pygeum africanum bark .........................................................2789Pyrantel embonate...................................................................2790Pyrazinamide ............................................................................ 2791Pyridostigmine bromide .........................................................2792Pyridoxine hydrochloride................................................6.6-5320Pyrimethamine .........................................................................2794Pyrogens (2.6.8.)......................................................................... 164Pyrrolidone.........................................................................6.5-4950

QQuality of non-sterile pharmaceutical preparations andsubstances for pharmaceutical use, microbiological(5.1.4.)................................................................................6.3-3957

Quantified hawthorn leaf and flower liquid extract.........2037Quinidine sulphate ..................................................................2799Quinine hydrochloride............................................................2800Quinine sulphate......................................................................2802

RRabbit haemorrhagic disease vaccine (inactivated) ........... 949Rabies immunoglobulin, human ..........................................2078Rabies vaccine for human use prepared in cellcultures .............................................................................6.1-3355

Rabies vaccine (inactivated) for veterinary use..........6.1-3375Rabies vaccine (live, oral) for foxes ........................................ 952Racecadotril .......................................................................6.3-4283Racemic camphor..................................................................... 1401Racemic ephedrine hydrochloride ....................................... 1792Racemic menthol .....................................................................2356Raclopride ([11C]methoxy) injection.....................................1005Radionuclides, table of physical characteristics (5.7.) ....... 633Radiopharmaceutical preparations ........................................ 695Radiopharmaceutical preparations, iobenguane sulphatefor .......................................................................................6.6-5189

Radiopharmaceutical preparations, pentetate sodiumcalcium for........................................................................6.3-4001

Raloxifene hydrochloride ................................................6.6-5325Raman spectrometry (2.2.48.) ................................................... 82Ramipril...............................................................................6.2-3826Ramon assay, flocculation value (Lf) of diphtheria andtetanus toxins and toxoids (2.7.27.) ..................................... 241

Ranitidine hydrochloride........................................................2809Rapeseed oil, refined........................................................6.6-5326Reagents (4.1.1.) ................................................................6.4-4421Reagents (4.1.1.) ................................................................6.5-4797Reagents (4.1.1.) ................................................................6.6-5125Reagents (4.) ......................................................................6.4-4421Reagents, standard solutions, buffer solutions(4.1.) ...................................................................................6.4-4421

Recombinant DNA technology, products of......................... 701Rectal capsules ........................................................................... 745Rectal foams................................................................................ 746Rectal preparations.................................................................... 744Rectal preparations, semi-solid ............................................... 746Rectal solutions and suspensions, powders and tabletsfor ................................................................................................ 744

Rectal solutions, emulsions and suspensions...................... 745Rectal tampons........................................................................... 746Red poppy petals...............................................................6.5-4955Reference standards (5.12.) ..................................................... 663Refractive index (2.2.6.) .............................................................. 26Relationship between reaction of solution, approximate pHand colour of certain indicators (2.2.4.) ............................... 25

Relative density (2.2.5.)............................................................... 25Repaglinide................................................................................ 2812Reserpine ................................................................................... 2814Residual solvents (5.4.) ............................................................. 603Residual solvents, identification and control (2.4.24.) ...... 121Residue on evaporation of essential oils (2.8.9.)................. 250Resistance to crushing of tablets (2.9.8.) ............................. 279Resorcinol .................................................................................. 2815Restharrow root ....................................................................... 2815Retroviridae-derived vectors for human use ...............6.6-5156Rhatany root ............................................................................. 2816Rhatany tincture ...................................................................... 2817Rhinotracheitis vaccine (inactivated), viral, feline ...............916Rhinotracheitis vaccine (live), viral, feline.............................917Rhubarb ..................................................................................... 2817Ribavirin..................................................................................... 2818Riboflavin...................................................................................2820Riboflavin sodium phosphate................................................ 2821Ribose in polysaccharide vaccines (2.5.31.) ......................... 147Ribwort plantain ......................................................................2823Rice starch..........................................................................6.3-4284Rifabutin ....................................................................................2825Rifampicin..................................................................................2826Rifamycin sodium.....................................................................2827Rifaximin.............................................................................6.5-4955Rilmenidine dihydrogen phosphate.....................................2829Risperidone ...............................................................................2830Ritonavir ....................................................................................2832Rocuronium bromide ..............................................................2835Roman chamomile flower ...................................................... 1487Ropivacaine hydrochloride monohydrate...........................2837Roselle .................................................................................6.1-3529Rosemary leaf ...........................................................................2839Rosemary oil .............................................................................2840Rotating viscometer method - viscosity (2.2.10.) .................. 28Rotation, optical (2.2.7.) ............................................................. 26Rotavirus vaccine (live, oral) ..........................................6.4-4561Roxithromycin...........................................................................2842RRR-α-Tocopherol ...................................................................3088RRR-α-Tocopheryl acetate .....................................................3090



RRR-α-Tocopheryl hydrogen succinate ..............................3095Rubber closures for containers for aqueous parenteralpreparations, for powders and for freeze-dried powders(3.2.9.) ........................................................................................ 386

Rubella immunoglobulin, human.........................................2079Rubella, measles and mumps vaccine (live) ................6.1-3347Rubella, measles, mumps and varicella vaccine(live) ...................................................................................6.6-5178

Rubella vaccine (live) .......................................................6.1-3358Rutoside trihydrate..................................................................2844

SSaccharin ...................................................................................2849Saccharin sodium ....................................................................2850Safety, viral (5.1.7.) .................................................................... 543Safflower flower ................................................................6.4-4683Safflower oil, refined........................................................6.6-5329Saffron for homoeopathic preparations..............................1084Sage leaf (salvia officinalis)....................................................2853Sage leaf, three-lobed..............................................................2854Sage oil, Spanish...............................................................6.2-3838Sage tincture.............................................................................2854Salbutamol ................................................................................2855Salbutamol sulphate ...............................................................2857Salicylic acid..............................................................................2859Salmeterol xinafoate................................................................2860Salmonella Enteritidis vaccine (inactivated) for chickens.. 953Salmonella Typhimurium vaccine (inactivated) forchickens ..................................................................................... 954

Salmon oil, farmed...................................................................2862Sanguisorba root...............................................................6.1-3533Saponification value (2.5.6.) .................................................... 139Saquinavir mesilate ..........................................................6.3-4287Saw palmetto fruit ...................................................................2864Schisandra fruit.................................................................6.3-4288Scopolamine.............................................................................. 2108Scopolamine butylbromide .................................................... 2109Scopolamine hydrobromide................................................... 2110Selamectin for veterinary use ........................................6.1-3534Selegiline hydrochloride ........................................................2866Selenium disulphide................................................................2867Semi-micro determination of water (2.5.12.) ........................141Semi-solid ear preparations ..................................................... 720Semi-solid eye preparations ..................................................... 722Semi-solid intrauterine preparations ............................6.3-3977Semi-solid nasal preparations.................................................. 732Semi-solid oromucosal preparations...................................... 733Semi-solid preparations for cutaneous application ...6.3-3979Semi-solid rectal preparations................................................. 746Semi-solid vaginal preparations.............................................. 752Senega root ...............................................................................2867Senna leaf ..................................................................................2868Senna leaf dry extract, standardised ............................6.3-4289Senna pods, Alexandrian........................................................2870Senna pods, Tinnevelly...........................................................2871Separation techniques, chromatographic (2.2.46.) ...6.4-4407Serine..........................................................................................2872Sertaconazole nitrate.......................................................6.1-3535Sertraline hydrochloride .................................................6.4-4684Sesame oil, refined ...........................................................6.6-5329Sets for the transfusion of blood and blood components(3.2.6.) ........................................................................................ 383

Sevoflurane ........................................................................6.3-4294Shampoos .................................................................................... 728Shellac ................................................................................6.2-3833Shingles (herpes zoster) vaccine (live) .........................6.3-3991Sialic acid in polysaccharide vaccines (2.5.23.)................... 144Siam benzoin tincture.............................................................1278Sieves (2.1.4.) .................................................................................16

Sieve test (2.9.12.)...................................................................... 283Sieving, analytical, particle-size distribution estimation by(2.9.38) (5.8.)....................................................................6.6-5145

Sieving, analytical, particle-size distribution estimation by(2.9.38.) .............................................................................6.6-5112

SI (International System) units (1.) ..............................6.5-4759Silica, colloidal anhydrous .....................................................2877Silica, colloidal hydrated ........................................................2877Silica, dental type.....................................................................2878Silica, hydrophobic colloidal .................................................2878Silicate, aluminium magnesium.....................................6.3-4024Silicate, aluminium sodium ............................................6.3-4026Silicone elastomer for closures and tubing (3.1.9.) ............ 358Silicone oil used as a lubricant (3.1.8.) ................................. 358Silk suture, sterile, braided, in distributor for veterinary use...................................................................................................1059

Silver, colloidal, for external use ..........................................2879Silver nitrate .............................................................................2880Simeticone.................................................................................2880Simvastatin.........................................................................6.4-4686Single-dose preparations, uniformity of content (2.9.6.)... 278Single-dose preparations, uniformity of mass (2.9.5.)........ 278Sintered-glass filters (2.1.2.) .......................................................15Size-exclusion chromatography (2.2.30.)................................ 47(S)-Lactic acid............................................................................2229Smallpox vaccine (live) ....................................................6.1-3359Sodium acetate ([1-11C]) injection.........................................1006Sodium acetate trihydrate .....................................................2883Sodium alendronate .........................................................6.3-4296Sodium alginate ................................................................6.6-5331Sodium aluminium silicate .............................................6.3-4026Sodium amidotrizoate.............................................................2886Sodium aminosalicylate dihydrate .......................................2887Sodium ascorbate .............................................................6.6-5332Sodium aurothiomalate..........................................................2889Sodium benzoate .....................................................................2890Sodium bromide....................................................................... 2891Sodium calcium edetate .........................................................2892Sodium calcium pentetate for radiopharmaceuticalpreparations.....................................................................6.3-4001

Sodium caprylate .....................................................................2893Sodium carbonate, anhydrous ..............................................2894Sodium carbonate decahydrate ............................................2894Sodium carbonate monohydrate ..........................................2895Sodium carboxymethylcellulose ........................................... 1423Sodium carboxymethylcellulose, cross-linked ............6.5-4865Sodium carboxymethylcellulose, low-substituted............. 1424Sodium cetostearyl sulphate .................................................2895Sodium chloride .......................................................................2897Sodium chromate (51Cr) sterile solution .............................1007Sodium citrate ..........................................................................2898Sodium cromoglicate ..............................................................2899Sodium cyclamate....................................................................2900Sodium dihydrogen phosphate dihydrate .......................... 2901Sodium fluoride .......................................................................2902Sodium fluoride (18F) injection .............................................1008Sodium fusidate .......................................................................2902Sodium glycerophosphate, hydrated ............................6.6-5333Sodium hyaluronate .........................................................6.3-4300Sodium hydrogen carbonate .................................................2906Sodium hydroxide....................................................................2907Sodium iodide...........................................................................2907Sodium iodide (123I) injection ................................................1009Sodium iodide (123I) solution for radiolabelling ................ 1010Sodium iodide (131I) capsules for diagnostic use................1011Sodium iodide (131I) capsules for therapeutic use ............ 1012Sodium iodide (131I) solution ................................................. 1013Sodium iodide (131I) solution for radiolabelling .................1014Sodium iodohippurate (123I) injection ..................................1014



Sodium iodohippurate (131I) injection ................................. 1015Sodium lactate solution..........................................................2908Sodium laurilsulfate ................................................................ 2910Sodium metabisulphite........................................................... 2911Sodium methyl parahydroxybenzoate................................. 2911Sodium molybdate (99Mo) solution (fission) ...................... 1016Sodium molybdate dihydrate .........................................6.3-4302Sodium nitrite........................................................................... 2913Sodium nitroprusside ............................................................. 2913Sodium perborate, hydrated.................................................. 2914Sodium pertechnetate (99mTc) injection (fission) .............. 1018Sodium pertechnetate (99mTc) injection (non-fission) ......1020Sodium phenylbutyrate ...................................................6.1-3539Sodium phosphate (32P) injection ........................................1020Sodium picosulfate ..........................................................6.5-4961Sodium polystyrene sulphonate ....................................6.3-4303Sodium propionate .................................................................. 2917Sodium propyl parahydroxybenzoate.................................. 2918Sodium salicylate ..................................................................... 2919Sodium selenite pentahydrate .............................................. 2919Sodium (S)-lactate solution ...................................................2909Sodium starch glycolate (type A) .........................................2920Sodium starch glycolate (type B) ......................................... 2921Sodium starch glycolate (type C) .........................................2922Sodium stearate ................................................................6.3-4304Sodium stearyl fumarate ........................................................2924Sodium sulphate, anhydrous.................................................2924Sodium sulphate decahydrate...............................................2925Sodium sulphite, anhydrous..................................................2926Sodium sulphite heptahydrate..............................................2926Sodium thiosulphate...............................................................2927Sodium valproate .....................................................................2927Soft capsules ............................................................................... 718Softening time determination of lipophilic suppositories(2.9.22.) ...................................................................................... 302

Soft extracts .......................................................................6.1-3344Solid dosage forms, dissolution test for (2.9.3.).........6.6-5091Solids by mercury porosimetry, porosity and pore-sizedistribution of (2.9.32.)..................................................6.2-3643

Solids, density of (2.2.42.) ...............................................6.6-5046Solids, gas pycnometric density of (2.9.23.)................6.2-3642Solids (porous) including powders, wettability of(2.9.45.) .............................................................................6.5-4791

Solubility in alcohol of essential oils (2.8.10.) ..................... 250Soluble tablets ............................................................................ 750Solutions, emulsions and suspensions, oral ........................ 729Solutions for haemodialysis...................................................2022Solutions for haemodialysis, concentrated, water fordiluting..............................................................................6.3-4163

Solutions for haemofiltration and for haemodiafiltra-tion............................................................................................2025

Solutions for organ preservation..........................................2929Solutions for peritoneal dialysis ...........................................2646Solutions, suspensions, intrauterine ............................6.3-3977Solvents, residual (5.4.) ............................................................ 603Solvents, residual, identification and control (2.4.24.) ...... 121Somatostatin .............................................................................2930Somatropin................................................................................ 2931Somatropin concentrated solution ......................................2933Somatropin for injection ........................................................2935Sorbic acid.................................................................................2937Sorbitan laurate .......................................................................2938Sorbitan oleate .........................................................................2938Sorbitan palmitate ...................................................................2939Sorbitan sesquioleate..............................................................2939Sorbitan stearate......................................................................2940Sorbitan trioleate .....................................................................2940Sorbitol................................................................................6.4-4688Sorbitol, liquid (crystallising)................................................2942

Sorbitol, liquid (non-crystallising)........................................2943Sorbitol, liquid, partially dehydrated............................6.3-4307Sotalol hydrochloride .............................................................2944Soya-bean oil, hydrogenated...........................................6.2-3837Soya-bean oil, refined.......................................................6.6-5334Spanish sage oil.................................................................6.2-3838Specific surface area by air permeability (2.9.14.).............. 283Specific surface area by gas adsorption (2.9.26)(5.8.)...................................................................................6.6-5144

Specific surface area by gas adsorption (2.9.26.) ......6.6-5100Spectinomycin dihydrochloride pentahydrate ..................2947Spectinomycin sulphate tetrahydrate for veterinary use ..2949Spectrometry, atomic absorption (2.2.23.) ............................. 37Spectrometry, atomic emission (2.2.22.)................................. 36Spectrometry, mass (2.2.43.) ..................................................... 68Spectrometry, nuclear magnetic resonance(2.2.33.) .............................................................................6.3-3909

Spectrometry, Raman (2.2.48.) ................................................. 82Spectrometry, X-ray fluorescence (2.2.37.)............................. 59Spectrophotometry, infrared absorption (2.2.24.)................ 39Spectrophotometry, near-infrared (2.2.40.)............................ 62Spectrophotometry, ultraviolet and visible absorption(2.2.25.) .........................................................................................41

SPF chicken flocks for the production and quality control ofvaccines (5.2.2.) ...............................................................6.6-5137

Spheroids and granules, friability of (2.9.41.)...................... 330Spike lavender oil .............................................................6.5-4962Spiramycin..........................................................................6.1-3540Spirapril hydrochloride monohydrate.................................2954Spironolactone .........................................................................2955Spot-on preparations................................................................. 753Sprays ........................................................................................... 753Sprays (liquid nasal) and drops (nasal) ................................. 731Squalane ....................................................................................2956Standard solutions for limit tests (4.1.2.) ....................6.4-4535Standards, reference (5.12.)..................................................... 663Stannous chloride dihydrate .................................................2959Stanozolol...........................................................................6.3-4308Star anise ...................................................................................2960Star anise oil .............................................................................2962Starch glycolate (type A), sodium ........................................2920Starch glycolate (type B), sodium ........................................ 2921Starch glycolate (type C), sodium ........................................2922Starch, maize .....................................................................6.3-4212Starch, potato ....................................................................6.3-4277Starch, pregelatinised ......................................................6.6-5335Starch, rice .........................................................................6.3-4284Starch, wheat .....................................................................6.3-4346Starflower (borage) oil, refined......................................6.6-5209Statistical analysis of results of biological assays and tests(5.3.)............................................................................................ 571

Stavudine...................................................................................2964Steam sterilisation of aqueous preparations, application ofthe F0 concept (5.1.5.)....................................................6.3-3958

Stearic acid.........................................................................6.5-4963Stearoyl macrogolglycerides .................................................2967Stearyl alcohol..........................................................................2968Stem cells, human haematopoietic ...............................6.3-4165Sterile braided silk suture in distributor for veterinaryuse.............................................................................................1059

Sterile catgut.............................................................................1045Sterile catgut in distributor for veterinary use .................1057Sterile containers of plasticised poly(vinyl chloride)for human blood containing anticoagulant solution(3.2.5.) ........................................................................................ 382

Sterile linen thread in distributor for veterinary use.......1058Sterile non-absorbable strands in distributor for veterinaryuse.............................................................................................1060

Sterile non-absorbable sutures .............................................1046



Sterile plastic containers for human blood and bloodcomponents (3.2.3.) ................................................................. 379

Sterile polyamide 6/6 suture in distributor for veterinaryuse.............................................................................................1059

Sterile polyamide 6 suture in distributor for veterinaryuse.............................................................................................1058

Sterile poly(ethylene terephthalate) suture in distributor forveterinary use .........................................................................1059

Sterile products, methods of preparation (5.1.1.) ............... 525Sterile single-use plastic syringes (3.2.8.) ............................. 384Sterile synthetic absorbable braided sutures ....................1050Sterile synthetic absorbable monofilament sutures.........1052Sterilisation procedures, biological indicators (5.1.2.) ...... 527Sterility (2.6.1.) ..................................................................6.3-3919Sterility, guidelines for using the test for (5.1.9.) ......6.3-3958Sterols in fatty oils (2.4.23.)..................................................... 120Sticks ............................................................................................ 748Sticks, intrauterine ...........................................................6.3-3977Sticks, nasal................................................................................. 732St. John’s wort...................................................................6.2-3839St. John’s wort dry extract, quantified.........................6.3-4309Stomata and stomatal index (2.8.3.) ...................................... 249Stramonium leaf.......................................................................2968Stramonium, prepared.....................................................6.2-3842Strands, sterile non-absorbable, in distributor for veterinaryuse ............................................................................................1060

Streptokinase concentrated solution ...........................6.2-3843Streptomycin sulphate ............................................................2972Strontium (89Sr) chloride injection ...................................... 1021Subdivision of tablets................................................................ 748Sublingual sprays, oromucosal drops and oromucosalsprays.......................................................................................... 732

Sublingual tablets and buccal tablets ................................... 734Substances for pharmaceutical use ..............................6.5-4811Substances for pharmaceutical use, control of impurities in(5.10.).................................................................................6.5-4805

Substances of animal origin for the productionof immunological veterinary medicinal products(5.2.5.) ...............................................................................6.5-4801

Sub-visible particles, particulate contamination (2.9.19.).. 300Succinylsulfathiazole .............................................................. 2974Sucrose................................................................................6.3-4311Sucrose monopalmitate...................................................6.5-4964Sucrose stearate ................................................................6.5-4965Sufentanil ..................................................................................2977Sufentanil citrate .....................................................................2978Sugars, lead in (2.4.10.) ............................................................ 115Sugar spheres ....................................................................6.3-4312Sulbactam sodium ............................................................6.2-3845Sulfacetamide sodium......................................................6.2-3847Sulfadiazine...............................................................................2983Sulfadimidine............................................................................2984Sulfadoxine................................................................................2984Sulfafurazole.............................................................................2985Sulfaguanidine..........................................................................2986Sulfamerazine...........................................................................2987Sulfamethizole..........................................................................2988Sulfamethoxazole ....................................................................2989Sulfamethoxypyridazine for veterinary use .......................2990Sulfanilamide ............................................................................ 2991Sulfasalazine .............................................................................2992Sulfathiazole .............................................................................2994Sulfinpyrazone .........................................................................2995Sulfisomidine ............................................................................2996Sulindac .....................................................................................2996Sulphated ash (2.4.14.) ..............................................................116Sulphates (2.4.13.) ......................................................................116Sulphur dioxide (2.5.29.).......................................................... 146Sulphur for external use ........................................................2998

Sulphuric acid...........................................................................2998Sulpiride.....................................................................................2999Sultamicillin .......................................................................6.1-3545Sultamicillin tosilate dihydrate......................................6.3-4313Sumatra benzoin......................................................................1278Sumatra benzoin tincture ......................................................1279Sumatriptan succinate.....................................................6.3-4315Sunflower oil, refined ......................................................6.6-5335Supercritical fluid chromatography (2.2.45.) .........................71Suppositories .............................................................................. 745Suppositories and pessaries, disintegration of (2.9.2.)...... 265Suppositories, lipophilic, softening time determination(2.9.22.) ...................................................................................... 302

Suspensions, solutions and emulsions, oral ........................ 729Suspensions, solutions, intrauterine ............................6.3-3977Sutures, sterile non-absorbable ............................................1046Sutures, sterile synthetic absorbable braided ..................1050Sutures, sterile synthetic absorbable monofilament ......1052Suxamethonium chloride.......................................................3007Suxibuzone................................................................................3008Sweet fennel.............................................................................. 1874Sweet orange oil.......................................................................3009Swelling index (2.8.4.)............................................................... 249Swine erysipelas vaccine (inactivated) .................................. 955Swine-fever vaccine (live, prepared in cell cultures),classical .............................................................................6.2-3669

Symbols and abbreviations (1.) ......................................6.5-4759Synthetic absorbable braided sutures, sterile ...................1050Synthetic absorbable monofilament sutures, sterile........1052Syringes, plastic, sterile single-use (3.2.8.) ........................... 384Syrups........................................................................................... 730

TTable of physical characteristics of radionuclides mentionedin the European Pharmacopoeia (5.7.) ............................... 633

Tablets .......................................................................................... 748Tablets and capsules, disintegration of (2.9.1.) ..........6.3-3943Tablets, buccal ............................................................................ 734Tablets, coated............................................................................ 749Tablets, dispersible .................................................................... 750Tablets, effervescent .................................................................. 749Tablets for intrauterine solutions and suspensions ..6.3-3977Tablets for use in the mouth ................................................... 750Tablets for vaginal solutions and suspensions .................... 752Tablets, gastro-resistant............................................................ 750Tablets, intrauterine .........................................................6.3-3977Tablets, modified-release .......................................................... 750Tablets, orodispersible .............................................................. 750Tablets, resistance to crushing (2.9.8.) ................................. 279Tablets, soluble........................................................................... 750Tablets, subdivision of .............................................................. 748Tablets, sublingual..................................................................... 734Tablets, uncoated ....................................................................... 749Tablets, uncoated, friability of (2.9.7) (5.8.) ................6.6-5144Tablets, uncoated, friability of (2.9.7.) ..........................6.6-5100Tablets, vaginal........................................................................... 752Talc.......................................................................................6.6-5339Tamoxifen citrate ..................................................................... 3014Tampons, ear............................................................................... 720Tampons, medicated ................................................................. 751Tampons, rectal .......................................................................... 746Tampons, vaginal, medicated .................................................. 752Tamsulosin hydrochloride ..............................................6.5-4969Tannic acid ................................................................................ 3018Tannins in herbal drugs, determination of (2.8.14.) .......... 255Tapped density of powders, bulk density and(2.9.34.) .............................................................................6.5-4789

Tartaric acid .............................................................................. 3018Teat dips....................................................................................... 753



Tea tree oil ................................................................................. 3019Teat sprays................................................................................... 753Technetium (99mTc) bicisate injection ..................................1022Technetium (99mTc) colloidal rhenium sulphide injection............................................................................................6.3-4002

Technetium (99mTc) colloidal sulphur injection .................1024Technetium (99mTc) colloidal tin injection ..........................1025Technetium (99mTc) etifenin injection ..................................1026Technetium (99mTc) exametazime injection ........................1027Technetium (99mTc) gluconate injection ..............................1028Technetium (99mTc) human albumin injection ...................1029Technetium (99mTc) macrosalb injection.......................6.3-4003Technetium (99mTc) mebrofenin injection ....................6.3-4004Technetium (99mTc) medronate injection............................. 1031Technetium (99mTc) mertiatide injection .............................1033Technetium (99mTc) microspheres injection.................6.3-4005Technetium (99mTc) pentetate injection...............................1035Technetium (99mTc) sestamibi injection ...............................1036Technetium (99mTc) succimer injection................................1037Technetium (99mTc) tin pyrophosphate injection........6.3-4006Teicoplanin .........................................................................6.6-5341Telmisartan.........................................................................6.3-4325Temazepam................................................................................3020Tenosynovitis avian viral vaccine (live) ................................. 875Tenoxicam...........................................................................6.5-4970Terazosin hydrochloride dihydrate ......................................3022Terbinafine hydrochloride...............................................6.6-5343Terbutaline sulphate ...............................................................3025Terconazole ........................................................................6.1-3553Terfenadine.........................................................................6.1-3554Terminology used in monographs on biological products(5.2.1.)......................................................................................... 547

Test for anticomplementary activity of immunoglobulin(2.6.17.)..............................................................................6.6-5081

Test for anti-D antibodies in human immunoglobulin forintravenous administration (2.6.26.) ..........................6.5-4781

Test for extractable volume of parenteral preparations(2.9.17.)....................................................................................... 287

Test for Fc function of immunoglobulin (2.7.9.) ........6.5-4785Test for methanol and 2-propanol (2.9.11.) .......................... 282Test for neurovirulence of live virus vaccines (2.6.18.) ..... 193Test for neurovirulence of poliomyelitis vaccine (oral)(2.6.19.) ...................................................................................... 193

Test for specified micro-organisms (microbiologicalexamination of non-sterile products) (2.6.13.) .........6.5-4773

Testosterone ..............................................................................3030Testosterone decanoate .......................................................... 3031Testosterone enantate.............................................................3033Testosterone isocaproate........................................................3034Testosterone propionate.........................................................3035Tests for extraneous agents in viral vaccines for human use(2.6.16.) ...................................................................................... 190

Tetanus and diphtheria toxins and toxoids, flocculation value(Lf) of, (Ramon assay) (2.7.27.) ............................................. 241

Tetanus and diphtheria vaccine (adsorbed, reducedantigen(s) content) .................................................................. 764

Tetanus antitoxin for human use ........................................... 969Tetanus antitoxin for veterinary use...................................... 976Tetanus, diphtheria and hepatitis B (rDNA) vaccine(adsorbed).................................................................................. 765

Tetanus, diphtheria and pertussis (acellular, component)vaccine (adsorbed)................................................................... 767

Tetanus, diphtheria and poliomyelitis (inactivated) vaccine(adsorbed, reduced antigen(s) content) .............................. 770

Tetanus, diphtheria, pertussis (acellular, component) andhaemophilus type b conjugate vaccine (adsorbed) .......... 771

Tetanus, diphtheria, pertussis (acellular, component) andhepatitis B (rDNA) vaccine (adsorbed) ............................... 774

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed) .................. 775

Tetanus, diphtheria, pertussis (acellular, component) andpoliomyelitis (inactivated) vaccine (adsorbed, reducedantigen(s) content) .................................................................. 778

Tetanus, diphtheria, pertussis (acellular, component),hepatitis B (rDNA), poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 780

Tetanus, diphtheria, pertussis (acellular, component),poliomyelitis (inactivated) and haemophilus type bconjugate vaccine (adsorbed).......................................6.3-3983

Tetanus, diphtheria, pertussis and poliomyelitis (inactivated)vaccine (adsorbed)................................................................... 785

Tetanus, diphtheria, pertussis, poliomyelitis (inactivated) andhaemophilus type b conjugate vaccine (adsorbed) .......... 787

Tetanus immunoglobulin, human ........................................2079Tetanus vaccine (adsorbed) ..................................................... 844Tetanus vaccine (adsorbed), assay of (2.7.8.) ....................... 223Tetanus vaccine for veterinary use ........................................ 957Tetracaine hydrochloride ................................................6.1-3556Tetracosactide....................................................................6.3-4326Tetracycline ...............................................................................3040Tetracycline hydrochloride .................................................... 3041Tetra-O-acetyl-mannose triflate for radiopharmaceuticalpreparations.....................................................................6.3-4008

Tetrazepam.........................................................................6.5-4972Tetryzoline hydrochloride......................................................3044Thallous (201Tl) chloride injection.........................................1039Theobromine.............................................................................3045Theophylline .............................................................................3046Theophylline-ethylenediamine, anhydrous..................6.6-5344Theophylline-ethylenediamine hydrate ........................6.6-5346Theophylline monohydrate....................................................3047Thermal analysis (2.2.34.) ...............................................6.1-3311Thermogravimetry (2.2.34.) ............................................6.1-3311Thiamazole ................................................................................3050Thiamine hydrochloride ......................................................... 3051Thiamine nitrate.......................................................................3053Thiamphenicol ..........................................................................3054Thin-layer chromatography (2.2.27.)........................................ 43Thioctic acid ..............................................................................3055Thiomersal.................................................................................3056Thiopental sodium and sodium carbonate.........................3057Thioridazine ..............................................................................3058Thioridazine hydrochloride ...................................................3059Three-lobed sage leaf...............................................................2854Threonine...................................................................................3060Thyme ..................................................................................6.4-4693Thyme oil ..................................................................................3063Thyme, wild ............................................................................... 3219Thymol........................................................................................3064Tiabendazole .............................................................................3064Tiamulin for veterinary use ............................................6.5-4973Tiamulin hydrogen fumarate for veterinary use ...............3068Tianeptine sodium ...................................................................3070Tiapride hydrochloride ...........................................................3071Tiaprofenic acid ........................................................................3072Tibolone ..................................................................................... 3074Ticarcillin sodium.....................................................................3075Tick-borne encephalitis vaccine (inactivated) ...................... 845Ticlopidine hydrochloride ......................................................3077Tilidine hydrochloride hemihydrate ....................................3079Timolol maleate ........................................................................3080Tinctures .............................................................................6.1-3344Tinidazole ...........................................................................6.2-3852Tinnevelly senna pods.............................................................2871Tinzaparin sodium...................................................................3082Tioconazole ...............................................................................3083Titanium dioxide ...............................................................6.4-4695



Titration, amperometric (2.2.19.).............................................. 35Titration, potentiometric (2.2.20.) ............................................ 35Titrations, complexometric (2.5.11.) ...................................... 140Tobramycin.........................................................................6.2-3854Tocopherol, all-rac-α- ..............................................................3086Tocopherol, RRR-α- .................................................................3088Tocopheryl acetate, all-rac-α- ................................................3089α-Tocopheryl acetate concentrate (powder form) ............ 3091Tocopheryl acetate, RRR-α-...................................................3090Tocopheryl hydrogen succinate, DL-α- ................................3093Tocopheryl hydrogen succinate, RRR-α- ............................3095Tolbutamide ..............................................................................3097Tolfenamic acid.........................................................................3097Tolnaftate............................................................................6.5-4975Tolu balsam ...............................................................................3099Torasemide, anhydrous........................................................... 3100Tormentil ....................................................................................3101Tormentil tincture.................................................................... 3102Tosylchloramide sodium......................................................... 3103Total ash (2.4.16.)........................................................................116Total cholesterol in oils rich in omega-3 acids (2.4.32.) .... 132Total organic carbon in water for pharmaceutical use(2.2.44.) .........................................................................................71

Total protein (2.5.33.) ............................................................... 148Toxicity, abnormal (2.6.9.)........................................................ 165Toxin, botulinum type A for injection..................................1327Tragacanth .........................................................................6.3-4328Tramadol hydrochloride ......................................................... 3104Tramazoline hydrochloride monohydrate .......................... 3106Trandolapril............................................................................... 3107Tranexamic acid ....................................................................... 3108Transdermal patches ................................................................. 737Transdermal patches, dissolution test for (2.9.4.) .............. 275Trapidil ....................................................................................... 3110Tretinoin .....................................................................................3111Triacetin ..................................................................................... 3112Triamcinolone........................................................................... 3112Triamcinolone acetonide.........................................................3114Triamcinolone hexacetonide ................................................. 3115Triamterene ........................................................................6.3-4329Tribenoside.................................................................................3117Tributyl acetylcitrate ........................................................6.6-5347Trichloroacetic acid ................................................................. 3119Triethanolamine ....................................................................... 3133Triethyl citrate .......................................................................... 3120Trifluoperazine hydrochloride .............................................. 3121Triflusal ...................................................................................... 3121Triglycerides, medium-chain...........................................6.6-5348Triglycerides, omega-3-acid.............................................6.3-4246Triglycerol diisostearate ..................................................6.1-3558Trihexyphenidyl hydrochloride............................................. 3125Trimetazidine dihydrochloride.............................................. 3126Trimethadione .......................................................................... 3127Trimethoprim............................................................................ 3128Trimipramine maleate............................................................. 3130Tri-n-butyl phosphate .............................................................. 3132Tritiated (3H) water injection.................................................1040Trolamine................................................................................... 3133Trometamol ............................................................................... 3135Tropicamide............................................................................... 3135Tropisetron hydrochloride ..................................................... 3136Trospium chloride.................................................................... 3138Troxerutin.................................................................................. 3139Trypsin ................................................................................6.3-4331Tryptophan.........................................................................6.3-4333TSE, animal, minimising the risk of transmitting via humanand veterinary medicinal products (5.2.8.) ........................ 558

TSE, animal, products with risk of transmitting agentsof.................................................................................................. 694

Tuberculin for human use, old.............................................. 3144Tuberculin purified protein derivative, avian .................... 3146Tuberculin purified protein derivative, bovine.................. 3147Tuberculin purified protein derivative for human use .... 3147Tubes for comparative tests (2.1.5.) ..........................................17Tubing and closures, silicone elastomer for (3.1.9.)........... 358Tubing and containers for total parenteral nutritionpreparations, poly(ethylene - vinyl acetate) for (3.1.7.) ... 356

Tubing used in sets for the transfusion of blood and bloodcomponents, materials based on plasticised poly(vinylchloride) for (3.1.1.2.) ............................................................. 342

Tubocurarine chloride ............................................................ 3150Turmeric, Javanese .................................................................. 3150Turpentine oil, Pinus pinaster type ..................................... 3151Tylosin for veterinary use ...................................................... 3152Tylosin phosphate bulk solution for veterinary use ........ 3154Tylosin tartrate for veterinary use ....................................... 3156Typhoid polysaccharide vaccine ............................................. 847Typhoid vaccine.......................................................................... 849Typhoid vaccine, freeze-dried.................................................. 849Typhoid vaccine (live, oral, strain Ty 21a)...................6.4-4563Tyrosine...................................................................................... 3157Tyrothricin................................................................................. 3158

UUbidecarenone.......................................................................... 3163Udder-washes .............................................................................. 753Ultraviolet and visible absorption spectrophotometry(2.2.25.) .........................................................................................41

Ultraviolet ray lamps for analytical purposes (2.1.3.)............15Uncoated tablets......................................................................... 749Undecylenic acid ...................................................................... 3164Uniformity of content of single-dose preparations(2.9.6.) ........................................................................................ 278

Uniformity of dosage units (2.9.40.) .............................6.1-3325Uniformity of mass of delivered doses from multidosecontainers (2.9.27.) .................................................................. 309

Uniformity of mass of single-dose preparations (2.9.5.) .... 278Units of the International System (SI) used in thePharmacopoeia and equivalence with other units(1.) ......................................................................................6.5-4759

Unsaponifiable matter (2.5.7.) ................................................. 139Urea............................................................................................. 3165Urofollitropin ............................................................................ 3166Urokinase................................................................................... 3167Uronic acids in polysaccharide vaccines (2.5.22.)............... 144Ursodeoxycholic acid ............................................................. 3168

VVaccines, adsorbed, aluminium in (2.5.13.)...........................141Vaccines, adsorbed, calcium in (2.5.14.)................................ 142Vaccines and immunosera, phenol in (2.5.15.) .................... 142Vaccines and immunosera, veterinary, evaluation of efficacyof (5.2.7.) ...........................................................................6.1-3335

Vaccines and immunosera, veterinary, evaluation of safety(5.2.6.) ........................................................................................ 556

Vaccines and immunosera, veterinary, evaluation of thesafety of each batch (5.2.9.) ................................................... 567

Vaccines for human use...................................................6.3-3971Vaccines for human use, cell substrates for the production of(5.2.3.) ...............................................................................6.3-3963

Vaccines for human use, viral, extraneous agents in(2.6.16.) ...................................................................................... 190

Vaccines for veterinary use...................................................... 707Vaccines, polysaccharide, hexosamines in (2.5.20.)............ 143Vaccines, polysaccharide, methylpentoses in (2.5.21.)....... 143Vaccines, polysaccharide, nucleic acids in (2.5.17.) ............ 142Vaccines, polysaccharide, O-acetyl in (2.5.19.)..................... 143



Vaccines, polysaccharide, phosphorus in (2.5.18.) ............. 142Vaccines, polysaccharide, protein in (2.5.16.) ...................... 142Vaccines, polysaccharide, ribose in (2.5.31.) ........................ 147Vaccines, polysaccharide, sialic acid in (2.5.23.) ................. 144Vaccines, polysaccharide, uronic acids in (2.5.22.)............. 144Vaccines, SPF chicken flocks for the production and qualitycontrol of (5.2.2.) ...........................................................6.6-5137

Vaccines, veterinary, cell cultures for the production of(5.2.4.) ........................................................................................ 553

Vaccines, viral live, test for neurovirulence (2.6.18.).......... 193Vaginal capsules ......................................................................... 752Vaginal foams.............................................................................. 752Vaginal preparations ................................................................. 751Vaginal preparations, semi-solid ............................................. 752Vaginal solutions and suspensions, tablets for.................... 752Vaginal solutions, emulsions and suspensions.................... 752Vaginal tablets ............................................................................ 752Vaginal tampons, medicated.................................................... 752Valerian dry aqueous extract ........................................6.4-4699Valerian dry hydroalcoholic extract..................................... 3173Valerian root...............................................................................3174Valerian tincture....................................................................... 3175Valine ...........................................................................................3176Valnemulin hydrochloride for veterinary use ................... 3177Valproic acid.............................................................................. 3178Valsartan .............................................................................6.6-5353Vancomycin hydrochloride .................................................... 3180Vanillin ....................................................................................... 3182Varicella immunoglobulin for intravenous administration,human ...................................................................................... 2081

Varicella immunoglobulin, human.......................................2080Varicella, measles, mumps and rubella vaccine (live)..6.6-5178Varicella vaccine (live)......................................................6.3-3992Vectors for human use, adenovirus ..............................6.6-5152Vectors for human use, plasmid ....................................6.6-5150Vectors for human use, plasmid, bacterial cells used for themanufacture of ................................................................6.6-5152

Vectors for human use, poxvirus...................................6.6-5154Vecuronium bromide............................................................... 3183Vedaprofen for veterinary use........................................6.5-4979Vegetable fatty oils............................................................6.4-4553Venlafaxine hydrochloride ..................................................... 3184Verapamil hydrochloride ........................................................ 3186Verbena herb............................................................................. 3188Veterinary liquid preparations for cutaneous application.. 752Veterinary medicinal products, immunological, substancesof animal origin for the production of (5.2.5.) .........6.5-4801

Veterinary vaccines and immunosera, evaluation of efficacyof (5.2.7.) ...........................................................................6.1-3335

Viability, nucleated cell count and (2.7.29.) ......................... 243Vibriosis (cold-water) vaccine (inactivated) forsalmonids..........................................................................6.2-3671

Vibriosis vaccine (inactivated) for salmonids..............6.2-3672VICH (5.8.) ..........................................................................6.6-5143Vinblastine sulphate................................................................ 3189Vincristine sulphate................................................................. 3190Vindesine sulphate .................................................................. 3192Vinorelbine tartrate ................................................................. 3194Vinpocetine................................................................................ 3196Viper venom antiserum, European ........................................ 970Viral rhinotracheitis vaccine (inactivated), feline.................916Viral rhinotracheitis vaccine (live), feline ..............................917Viral safety (5.1.7.) ..................................................................... 543Viscometer method, capillary (2.2.9.) ...................................... 27Viscometer method, falling ball (2.2.49.) ................................ 84Viscose wadding, absorbent .................................................. 3197Viscosity (2.2.8.) ........................................................................... 27Viscosity - rotating viscometer method (2.2.10.) ................... 28

Visible and ultraviolet absorption spectrophotometry(2.2.25.) .........................................................................................41

Visible particles, particulate contamination (2.9.20.) ........ 302Vitamin A ................................................................................... 3199Vitamin A concentrate (oily form), synthetic .....................3200Vitamin A concentrate (powder form), synthetic .............. 3201Vitamin A concentrate (solubilisate/emulsion),synthetic ..................................................................................3203

Volumetric analysis (4.2.) ................................................6.4-4545Volumetric solutions (4.2.2.)...........................................6.4-4546Volumetric solutions, primary standards for (4.2.1.) ..6.4-4545von Willebrand factor, human .............................................. 2081von Willebrand factor, human, assay of (2.7.21.) ................ 237

WWarfarin sodium.......................................................................3207Warfarin sodium clathrate .....................................................3208Washes, nasal.............................................................................. 732Water (15O) injection................................................................1040Water, determination by distillation (2.2.13.) .........................31Water for diluting concentrated haemodialysissolutions ...........................................................................6.3-4163

Water for injections ..........................................................6.3-4339Water for pharmaceutical use, total organic carbon in(2.2.44.) .........................................................................................71

Water, highly purified ......................................................6.3-4342Water in essential oils (2.8.5.) ................................................. 249Water in gases (2.5.28.) ............................................................ 146Water : micro determination (2.5.32.) .................................... 147Water, purified...................................................................6.3-4344Water : semi-micro determination (2.5.12.)............................141Wettability of porous solids including powders(2.9.45.) .............................................................................6.5-4791

Wheat-germ oil, refined ...................................................6.6-5357Wheat-germ oil, virgin......................................................6.6-5357Wheat starch ......................................................................6.3-4346White beeswax ..........................................................................1260White horehound..................................................................... 3216White soft paraffin............................................................6.5-4941Wild pansy (flowering aerial parts) ...................................... 3217Wild thyme ................................................................................ 3219Willow bark ........................................................................6.1-3563Willow bark dry extract ...................................................6.1-3564Wool alcohols............................................................................ 3221Wool fat ......................................................................................3222Wool fat, hydrogenated...........................................................3226Wool fat, hydrous.....................................................................3227Wormwood ................................................................................3228

XXanthan gum .....................................................................6.4-4703Xenon (133Xe) injection............................................................1042X-ray fluorescence spectrometry (2.2.37.)............................... 59X-ray powder diffraction (XRPD), characterisationof crystalline and partially crystalline solids by(2.9.33.) .............................................................................6.3-3945

Xylazine hydrochloride for veterinary use .........................3234Xylitol...................................................................................6.3-4350Xylometazoline hydrochloride ..............................................3237Xylose..........................................................................................3238

YYarrow ........................................................................................3243Yellow beeswax ......................................................................... 1261Yellow fever vaccine (live) ...............................................6.1-3365Yellow soft paraffin...........................................................6.2-3816Yohimbine hydrochloride .......................................................3244



ZZidovudine..........................................................................6.5-4983Zinc acetate dihydrate.............................................................3250Zinc acexamate ......................................................................... 3251Zinc chloride ......................................................................6.6-5361Zinc gluconate ...................................................................6.5-4984Zinc oxide...................................................................................3253Zinc stearate..............................................................................3254

Zinc sulphate heptahydrate ...................................................3254Zinc sulphate hexahydrate.....................................................3255Zinc sulphate monohydrate ............................................6.6-5361Zinc undecylenate ....................................................................3256Zolpidem tartrate .....................................................................3256Zopiclone ...................................................................................3257Zoster (shingles) vaccine (live), herpes ........................6.3-3991Zuclopenthixol decanoate ......................................................3259


numerics 2.2.5. relative density25 6.5 6.1-3313 2.2.6 ... pharmacopoeia 6.6 index numerics 1....

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