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detailed certificates of analysis • acknowledged by regulatory authorities worldw
ide • pharmaceutical im
purities • custom synthesised impurities • pharmaceutical primary standards
Impurity testing beyond pharmacopeial methods
LGC Quality - ISO Guide 34 • GMP/GLP • ISO 9001 • ISO/IEC 17025 • ISO/IEC 17043
ALL LGC PRODUCTS
LINK DIRECTLY TO
WEBSHOP
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LGC Quality - ISO Guide 34 • GMP/GLP • ISO 9001 • ISO/IEC 17025 • ISO/IEC 17043
© LGC Limited, 2015. All rights reserved. LGC Standards is part of the LGC Group. 4573/GJ/1015
www.lgcstandards.com • Science for a safer world
More than 5,000 impurities from Atorvastatin to Zopiclone
LGC offers over 5,000 reference materials to identify and quantify impurities in APIs, finished dosage forms and excipients.
• Get all your impurities from a single source• Over 5,000 impurities from all relevant
suppliers• Compliant with ICH guidelines Q3A and Q3B • LGC manufactured impurities accompanied
by the most detailed certificate of analysis• Customised impurities available from LGC
@LGCStdsPharma
4573_Impurities_advert_A4_1015-CB.indd 1 10/30/2015 3:55:43 PM
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Regulatory backgroundImpurity reference materials are designed to detect, identify, quantify and qualify impurities in a drug substance in accordance with the ICH guidelines Q3A to Q3D and Q7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
The ICH does not prioritise at any point any given range of standards over another, whether officially recognised or not, for use within the pharmaceutical industry. Rather, it is central that the chosen reference material is suitable for its intended use.
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Always supplied Supplied depending on purpose and/or request Not supplied
Identity confirmation Purity analysis Residuals analysis Assay Intended use3
IR NMR MS HPLC Water Residual solventsSulphated
ashMass
balanceOrthogonal
method
Reference standards by LGC
LGC impurity standard1 Universal
Other materials
Pharmacopoeial standard2 Monograph
1 LGC impurity standards can be identified by the product code part “MM” in catalogues and on the webshop at www.lgcstandards.com.2 Pharmacopoeial standards are normally characterised for their intended purpose. This information is not typically available to users.3 Universal: For in-house quantitative and qualitative QC applications and for method validation. Also for monograph when compared to compendial RS. Monograph: Pharmacopoeial reference standards are designed and to be used strictly for the purpose of the monograph. The risk of incorrect use lies with the
user. Assay is provided if used quantitatively, and may be derived from mass balance and orthogonal method.
How to navigate your way through the reference materials maze?
Pharmacopoeial/Monographstandards
A pharmacopoeial reference standard is a reference standard for active ingredients, excipients and impurity substances established under the aegis of and approved by the relevant Pharmacopoeia, such as USP, EP, BP and JP.
Pharmacopoeial reference standards should only be used for the purposes which are described in the relevant monograph, for which they can be considered a primary reference standard. This is because they have been characterised and tested only for suitability for the official purpose, and they are not supplied with a detailed certificate of analysis thus significantly limiting their usability and value. Other than in those specific situations, the official status of these materials is not valid.
In general text 5.12, the EP states:
‘European Pharmacopoeia Chemical Reference Substance. A substance ... intended for use as stated in a monograph ... of the European Pharmacopoeia.’
and ‘If a European Pharmacopoeia reference
standard is to be used for any purpose other than that for which it has been established, its suitability for the new use has to be fully demonstrated ... Any value
assigned to a reference standard is valid for the intended use and not necessarily for other uses.’
In general chapter , the USP states:
‘When approved as suitable for use … in the USP, USP RS also assume official status and legal recognition in the US. Assessment of the suitability for use in other applications rests with the user.’
Indeed, cases have been reported to LGC where users were challenged by the regulatory authorities to justify the off-compendial use of pharmacopoeial materials or users have contacted LGC seeking advice on how to avoid such regulatory challenges.
LGC impurity reference standards
LGC Standards has a catalogue of over 3,500 impurity reference standards developed over 20 years serving the pharmaceutical industry. These standards are released with a quantitative and qualitative certificate of analysis (CoA) according to ISO 9001:2015. They are valid impurity reference standards for the development and validation of analytical methods, routine quality control and stability testing.
Have a look at the table below which visualises the differences between pharmacopoeial reference materials and LGC impurity standards.
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How this listing can help you
In our catalogue ‘Pharmaceutical impurities and primary reference standards’ we have already linked our impurity standards to the listings of EP wherever possible. With this catalogue, we respond to the demand of the pharmaceutical industry to also link our products to the USP descriptions. This listing of almost 500 compounds on the following pages contains the compound description and part number according to USP, suitable chemical name(s) and the corresponding LGC part number of our equivalent impurity reference standard.
Please note that in some cases salt forms or different salt forms of the compounds are provided. It is strongly recommended that prior to ordering the user checks to ensure that the LGC suggested alternative will be suitable for its intended use.
We believe that this listing – together with our catalogue – will be a valuable resource for
all users who want to benefit from the many advantages that LGC’s impurity standards can offer when non-pharmacopoeial methods have to be developed and applied, including:
Detailed CofA with qualitative and quantitative characterisation for method development, validation and ongoing use in stability testing and quality control
Certainty of consistent supply, not dependant on monograph changes
Compared to other suppliers and the documentation of their products, we offer an attractive price on a per-mg basis and in many cases our products are cheaper on a per-mg basis than the pharmacopoeial equivalents.
For further information or to see if we can match other pharmacopoeial standards against our range of products, please contact your local LGC office or send an email to [email protected].
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Example certificate of analysis Front cover
MM0095.16 lot number 15573 page 6/6
III. Water Content
Method: Karl Fischer titration
Results: Average 0.20 %
Number of results n=3
Standard deviation 0.01 %
IV. Residual Solvents
Method: 1H-NMR
Result: 0.46 % Chloroform
0.04 % n-Hexane
V. Final Result
Total impurities (HPLC) 0.15 %
Water content 0.20 %
Residual solvents 0.50 %
Assay (100 % method)1 99.15 %
The assay is assessed to be 99.2 % ‘as is’
The assay 'as is' is equivalent to the assay based on the not anhydrous and not dried substance respectively.
Release Date: 2012-05-24 LGC GmbH
Dr. Sabine Schröder
Product Release
1 The calculation of the 100 % method follows the formula:
Assay (%) = (100 % - KF - RES) Purity HPLC (%)100 %*
Water (KF) and Residual solvents (RES) are considered as absolute contributions, HPLC purity is considered as relative
contribution.
Certificate_ref_substance.indd 6 1/14/2014 12:41:42 PM
MM0095.16 lot number 15573 page 5/6
Minutes0 5 10 15 20 25 30 35
mA
U
0
100
200
300
400
500
600
mA
U
0
100
200
300
400
500
600
3.66
5.95
8.40
12.7
2
15.1
8
23.0
7
Surveyor PDA 4-220nmRetention Time
Area Percent Report - Sorted by Signal
Pk # Retention Time Area Area % 1 3.66 1422 0.02 2 5.95 2481 0.04 3 8.40 6745401 99.85 4 12.72 1480 0.02 5 15.18 3383 0.05 6 23.07 1693 0.03
Totals 6755860 100.00
For the calculation the system peaks were ignored. The content of the analyte was determined as ratio of
the peak area of the analyte and the cumulative areas of the purities, added up to 100 %.
Results: Average 99.85 %
Number of results n=3
Standard deviation 0.01 %
Certificate_ref_substance.indd 5 1/14/2014 12:41:41 PM
MM0095.16 lot number 15573 page 4/6
Ic. IR Spectrum
Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy
The signals of the IR spectrum and their interpretation are consistent with the structural formula.
II. Purity
The purity of the reference substance was analysed by high performance liquid chromatography (HPLC).
HPLC Conditions:
Column: Conditions: Detector: Injector:
Hypersil Gold (C18) 1.0 ml/min, 40 °C DAD Auto
5 µm, 150 x 4.6 mm 0 – 15 min Water/Acetonitrile 80/20 15 – 20 min Water/Acetonitrile to 60/40 20 – 25 min Water/Acetonitrile 60/40 25 – 30 min Water/Acetonitrile to 80/20 30 – 35 min Water/Acetonitrile 80/20 (v/v);
0.1 % H3PO4
220 nm 5 µl; 0.0654 mg/ml in
Water/Acetonitrile 50/50 (v/v)
Certificate_ref_substance.indd 4 1/14/2014 12:41:41 PM
MM0095.16 lot number 15573 page 3/6
Ib. Mass Spectrum
Method: 4.5 kV ESI; vaporization temperature: 200 °C, direct inlet
m/z fragments
376 [ M – H ]
211 [ C8H7N2O3S ]
147 [ C8H7N2O ]
The signals of the mass spectrum and their interpretation are consistent with the structural formula.
Certificate_ref_substance.indd 3 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 2/6
I. Identity
The identity of the reference substance was established by following analyses.
Ia. 1H-NMR Spectrum
Conditions: 400 MHz, DMSO-d6
The structure is confirmed with the signals of the spectrum and their interpretation.
Certificate_ref_substance.indd 2 1/14/2014 12:41:40 PM
6 pages
Catalogue Number: MM0095.16
Lot Number: 15573
Long-term Storage: 2 to 8 °C, dark
Appearance: white solid
Melting Point: 185 °C (dec.)
Assay ‘as is’: 99.2 %
Reference Substance
4-Methoxy-2-[[(5-methoxy-1H-benzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole Sulphone N-Oxide)
N
OS
NH
N
O
OO O
Molecular Formula: C17H19N3O5S Molecular Weight: 377.42 CAS Number: [ 158812-85-2 ]
Date of shipment:
This certificate is valid for two years from the date of shipment provided the substance is stored under the recommended conditions.
Certificate of analysis - impurities reference materials
CERTIFICATE
analysis • consultancy• validation • research
LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, GermanyTel: +49 3371 68 16 80 Fax: +49 3371 68 16 89 Web: www.lgcgroup.com
Certificate_ref_substance.indd 1 1/14/2014 12:41:40 PM
6 pages
Catalogue Number: MM0095.16
Lot Number: 15573
Long-term Storage: 2 to 8 °C, dark
Appearance: white solid
Melting Point: 185 °C (dec.)
Assay ‘as is’: 99.2 %
Reference Substance
4-Methoxy-2-[[(5-methoxy-1H-benzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole Sulphone N-Oxide)
N
OS
NH
N
O
OO O
Molecular Formula: C17H19N3O5S Molecular Weight: 377.42 CAS Number: [ 158812-85-2 ]
Date of shipment:
This certificate is valid for two years from the date of shipment provided the substance is stored under the recommended conditions.
Certificate of analysis - impurities reference materials
CERTIFICATE
analysis • consultancy• validation • research
LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, GermanyTel: +49 3371 68 16 80 Fax: +49 3371 68 16 89 Web: www.lgcgroup.com
Certificate_ref_substance.indd 1 1/14/2014 12:41:40 PM
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MM0095.16 lot number 15573 page 6/6
III. Water Content
Method: Karl Fischer titration
Results: Average 0.20 %
Number of results n=3
Standard deviation 0.01 %
IV. Residual Solvents
Method: 1H-NMR
Result: 0.46 % Chloroform
0.04 % n-Hexane
V. Final Result
Total impurities (HPLC) 0.15 %
Water content 0.20 %
Residual solvents 0.50 %
Assay (100 % method)1 99.15 %
The assay is assessed to be 99.2 % ‘as is’
The assay 'as is' is equivalent to the assay based on the not anhydrous and not dried substance respectively.
Release Date: 2012-05-24 LGC GmbH
Dr. Sabine Schröder
Product Release
1 The calculation of the 100 % method follows the formula:
Assay (%) = (100 % - KF - RES) Purity HPLC (%)100 %*
Water (KF) and Residual solvents (RES) are considered as absolute contributions, HPLC purity is considered as relative
contribution.
Certificate_ref_substance.indd 6 1/14/2014 12:41:42 PM
MM0095.16 lot number 15573 page 5/6
Minutes0 5 10 15 20 25 30 35
mA
U
0
100
200
300
400
500
600
mA
U
0
100
200
300
400
500
600
3.66
5.95
8.40
12.7
2
15.1
8
23.0
7
Surveyor PDA 4-220nmRetention Time
Area Percent Report - Sorted by Signal
Pk # Retention Time Area Area % 1 3.66 1422 0.02 2 5.95 2481 0.04 3 8.40 6745401 99.85 4 12.72 1480 0.02 5 15.18 3383 0.05 6 23.07 1693 0.03
Totals 6755860 100.00
For the calculation the system peaks were ignored. The content of the analyte was determined as ratio of
the peak area of the analyte and the cumulative areas of the purities, added up to 100 %.
Results: Average 99.85 %
Number of results n=3
Standard deviation 0.01 %
Certificate_ref_substance.indd 5 1/14/2014 12:41:41 PM
MM0095.16 lot number 15573 page 4/6
Ic. IR Spectrum
Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy
The signals of the IR spectrum and their interpretation are consistent with the structural formula.
II. Purity
The purity of the reference substance was analysed by high performance liquid chromatography (HPLC).
HPLC Conditions:
Column: Conditions: Detector: Injector:
Hypersil Gold (C18) 1.0 ml/min, 40 °C DAD Auto
5 µm, 150 x 4.6 mm 0 – 15 min Water/Acetonitrile 80/20 15 – 20 min Water/Acetonitrile to 60/40 20 – 25 min Water/Acetonitrile 60/40 25 – 30 min Water/Acetonitrile to 80/20 30 – 35 min Water/Acetonitrile 80/20 (v/v);
0.1 % H3PO4
220 nm 5 µl; 0.0654 mg/ml in
Water/Acetonitrile 50/50 (v/v)
Certificate_ref_substance.indd 4 1/14/2014 12:41:41 PM
MM0095.16 lot number 15573 page 3/6
Ib. Mass Spectrum
Method: 4.5 kV ESI; vaporization temperature: 200 °C, direct inlet
m/z fragments
376 [ M – H ]
211 [ C8H7N2O3S ]
147 [ C8H7N2O ]
The signals of the mass spectrum and their interpretation are consistent with the structural formula.
Certificate_ref_substance.indd 3 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 2/6
I. Identity
The identity of the reference substance was established by following analyses.
Ia. 1H-NMR Spectrum
Conditions: 400 MHz, DMSO-d6
The structure is confirmed with the signals of the spectrum and their interpretation.
Certificate_ref_substance.indd 2 1/14/2014 12:41:40 PM
Example certificate of analysis Page 2
6 pages
Catalogue Number: MM0095.16
Lot Number: 15573
Long-term Storage: 2 to 8 °C, dark
Appearance: white solid
Melting Point: 185 °C (dec.)
Assay ‘as is’: 99.2 %
Reference Substance
4-Methoxy-2-[[(5-methoxy-1H-benzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole Sulphone N-Oxide)
N
OS
NH
N
O
OO O
Molecular Formula: C17H19N3O5S Molecular Weight: 377.42 CAS Number: [ 158812-85-2 ]
Date of shipment:
This certificate is valid for two years from the date of shipment provided the substance is stored under the recommended conditions.
Certificate of analysis - impurities reference materials
CERTIFICATE
analysis • consultancy• validation • research
LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, GermanyTel: +49 3371 68 16 80 Fax: +49 3371 68 16 89 Web: www.lgcgroup.com
Certificate_ref_substance.indd 1 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 2/6
I. Identity
The identity of the reference substance was established by following analyses.
Ia. 1H-NMR Spectrum
Conditions: 400 MHz, DMSO-d6
The structure is confirmed with the signals of the spectrum and their interpretation.
Certificate_ref_substance.indd 2 1/14/2014 12:41:40 PM
-
MM0095.16 lot number 15573 page 6/6
III. Water Content
Method: Karl Fischer titration
Results: Average 0.20 %
Number of results n=3
Standard deviation 0.01 %
IV. Residual Solvents
Method: 1H-NMR
Result: 0.46 % Chloroform
0.04 % n-Hexane
V. Final Result
Total impurities (HPLC) 0.15 %
Water content 0.20 %
Residual solvents 0.50 %
Assay (100 % method)1 99.15 %
The assay is assessed to be 99.2 % ‘as is’
The assay 'as is' is equivalent to the assay based on the not anhydrous and not dried substance respectively.
Release Date: 2012-05-24 LGC GmbH
Dr. Sabine Schröder
Product Release
1 The calculation of the 100 % method follows the formula:
Assay (%) = (100 % - KF - RES) Purity HPLC (%)100 %*
Water (KF) and Residual solvents (RES) are considered as absolute contributions, HPLC purity is considered as relative
contribution.
Certificate_ref_substance.indd 6 1/14/2014 12:41:42 PM
MM0095.16 lot number 15573 page 5/6
Minutes0 5 10 15 20 25 30 35
mA
U
0
100
200
300
400
500
600
mA
U
0
100
200
300
400
500
600
3.66
5.95
8.40
12.7
2
15.1
8
23.0
7
Surveyor PDA 4-220nmRetention Time
Area Percent Report - Sorted by Signal
Pk # Retention Time Area Area % 1 3.66 1422 0.02 2 5.95 2481 0.04 3 8.40 6745401 99.85 4 12.72 1480 0.02 5 15.18 3383 0.05 6 23.07 1693 0.03
Totals 6755860 100.00
For the calculation the system peaks were ignored. The content of the analyte was determined as ratio of
the peak area of the analyte and the cumulative areas of the purities, added up to 100 %.
Results: Average 99.85 %
Number of results n=3
Standard deviation 0.01 %
Certificate_ref_substance.indd 5 1/14/2014 12:41:41 PM
MM0095.16 lot number 15573 page 4/6
Ic. IR Spectrum
Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy
The signals of the IR spectrum and their interpretation are consistent with the structural formula.
II. Purity
The purity of the reference substance was analysed by high performance liquid chromatography (HPLC).
HPLC Conditions:
Column: Conditions: Detector: Injector:
Hypersil Gold (C18) 1.0 ml/min, 40 °C DAD Auto
5 µm, 150 x 4.6 mm 0 – 15 min Water/Acetonitrile 80/20 15 – 20 min Water/Acetonitrile to 60/40 20 – 25 min Water/Acetonitrile 60/40 25 – 30 min Water/Acetonitrile to 80/20 30 – 35 min Water/Acetonitrile 80/20 (v/v);
0.1 % H3PO4
220 nm 5 µl; 0.0654 mg/ml in
Water/Acetonitrile 50/50 (v/v)
Certificate_ref_substance.indd 4 1/14/2014 12:41:41 PM
MM0095.16 lot number 15573 page 3/6
Ib. Mass Spectrum
Method: 4.5 kV ESI; vaporization temperature: 200 °C, direct inlet
m/z fragments
376 [ M – H ]
211 [ C8H7N2O3S ]
147 [ C8H7N2O ]
The signals of the mass spectrum and their interpretation are consistent with the structural formula.
Certificate_ref_substance.indd 3 1/14/2014 12:41:40 PM
Example certificate of analysis Page 3
MM0095.16 lot number 15573 page 2/6
I. Identity
The identity of the reference substance was established by following analyses.
Ia. 1H-NMR Spectrum
Conditions: 400 MHz, DMSO-d6
The structure is confirmed with the signals of the spectrum and their interpretation.
Certificate_ref_substance.indd 2 1/14/2014 12:41:40 PM
6 pages
Catalogue Number: MM0095.16
Lot Number: 15573
Long-term Storage: 2 to 8 °C, dark
Appearance: white solid
Melting Point: 185 °C (dec.)
Assay ‘as is’: 99.2 %
Reference Substance
4-Methoxy-2-[[(5-methoxy-1H-benzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole Sulphone N-Oxide)
N
OS
NH
N
O
OO O
Molecular Formula: C17H19N3O5S Molecular Weight: 377.42 CAS Number: [ 158812-85-2 ]
Date of shipment:
This certificate is valid for two years from the date of shipment provided the substance is stored under the recommended conditions.
Certificate of analysis - impurities reference materials
CERTIFICATE
analysis • consultancy• validation • research
LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, GermanyTel: +49 3371 68 16 80 Fax: +49 3371 68 16 89 Web: www.lgcgroup.com
Certificate_ref_substance.indd 1 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 3/6
Ib. Mass Spectrum
Method: 4.5 kV ESI; vaporization temperature: 200 °C, direct inlet
m/z fragments
376 [ M – H ]
211 [ C8H7N2O3S ]
147 [ C8H7N2O ]
The signals of the mass spectrum and their interpretation are consistent with the structural formula.
Certificate_ref_substance.indd 3 1/14/2014 12:41:40 PM
-
MM0095.16 lot number 15573 page 6/6
III. Water Content
Method: Karl Fischer titration
Results: Average 0.20 %
Number of results n=3
Standard deviation 0.01 %
IV. Residual Solvents
Method: 1H-NMR
Result: 0.46 % Chloroform
0.04 % n-Hexane
V. Final Result
Total impurities (HPLC) 0.15 %
Water content 0.20 %
Residual solvents 0.50 %
Assay (100 % method)1 99.15 %
The assay is assessed to be 99.2 % ‘as is’
The assay 'as is' is equivalent to the assay based on the not anhydrous and not dried substance respectively.
Release Date: 2012-05-24 LGC GmbH
Dr. Sabine Schröder
Product Release
1 The calculation of the 100 % method follows the formula:
Assay (%) = (100 % - KF - RES) Purity HPLC (%)100 %*
Water (KF) and Residual solvents (RES) are considered as absolute contributions, HPLC purity is considered as relative
contribution.
Certificate_ref_substance.indd 6 1/14/2014 12:41:42 PM
MM0095.16 lot number 15573 page 5/6
Minutes0 5 10 15 20 25 30 35
mA
U
0
100
200
300
400
500
600
mA
U
0
100
200
300
400
500
600
3.66
5.95
8.40
12.7
2
15.1
8
23.0
7
Surveyor PDA 4-220nmRetention Time
Area Percent Report - Sorted by Signal
Pk # Retention Time Area Area % 1 3.66 1422 0.02 2 5.95 2481 0.04 3 8.40 6745401 99.85 4 12.72 1480 0.02 5 15.18 3383 0.05 6 23.07 1693 0.03
Totals 6755860 100.00
For the calculation the system peaks were ignored. The content of the analyte was determined as ratio of
the peak area of the analyte and the cumulative areas of the purities, added up to 100 %.
Results: Average 99.85 %
Number of results n=3
Standard deviation 0.01 %
Certificate_ref_substance.indd 5 1/14/2014 12:41:41 PM
MM0095.16 lot number 15573 page 4/6
Ic. IR Spectrum
Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy
The signals of the IR spectrum and their interpretation are consistent with the structural formula.
II. Purity
The purity of the reference substance was analysed by high performance liquid chromatography (HPLC).
HPLC Conditions:
Column: Conditions: Detector: Injector:
Hypersil Gold (C18) 1.0 ml/min, 40 °C DAD Auto
5 µm, 150 x 4.6 mm 0 – 15 min Water/Acetonitrile 80/20 15 – 20 min Water/Acetonitrile to 60/40 20 – 25 min Water/Acetonitrile 60/40 25 – 30 min Water/Acetonitrile to 80/20 30 – 35 min Water/Acetonitrile 80/20 (v/v);
0.1 % H3PO4
220 nm 5 µl; 0.0654 mg/ml in
Water/Acetonitrile 50/50 (v/v)
Certificate_ref_substance.indd 4 1/14/2014 12:41:41 PM
Example certificate of analysis Page 4
MM0095.16 lot number 15573 page 3/6
Ib. Mass Spectrum
Method: 4.5 kV ESI; vaporization temperature: 200 °C, direct inlet
m/z fragments
376 [ M – H ]
211 [ C8H7N2O3S ]
147 [ C8H7N2O ]
The signals of the mass spectrum and their interpretation are consistent with the structural formula.
Certificate_ref_substance.indd 3 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 2/6
I. Identity
The identity of the reference substance was established by following analyses.
Ia. 1H-NMR Spectrum
Conditions: 400 MHz, DMSO-d6
The structure is confirmed with the signals of the spectrum and their interpretation.
Certificate_ref_substance.indd 2 1/14/2014 12:41:40 PM
6 pages
Catalogue Number: MM0095.16
Lot Number: 15573
Long-term Storage: 2 to 8 °C, dark
Appearance: white solid
Melting Point: 185 °C (dec.)
Assay ‘as is’: 99.2 %
Reference Substance
4-Methoxy-2-[[(5-methoxy-1H-benzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole Sulphone N-Oxide)
N
OS
NH
N
O
OO O
Molecular Formula: C17H19N3O5S Molecular Weight: 377.42 CAS Number: [ 158812-85-2 ]
Date of shipment:
This certificate is valid for two years from the date of shipment provided the substance is stored under the recommended conditions.
Certificate of analysis - impurities reference materials
CERTIFICATE
analysis • consultancy• validation • research
LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, GermanyTel: +49 3371 68 16 80 Fax: +49 3371 68 16 89 Web: www.lgcgroup.com
Certificate_ref_substance.indd 1 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 4/6
Ic. IR Spectrum
Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy
The signals of the IR spectrum and their interpretation are consistent with the structural formula.
II. Purity
The purity of the reference substance was analysed by high performance liquid chromatography (HPLC).
HPLC Conditions:
Column: Conditions: Detector: Injector:
Hypersil Gold (C18) 1.0 ml/min, 40 °C DAD Auto
5 µm, 150 x 4.6 mm 0 – 15 min Water/Acetonitrile 80/20 15 – 20 min Water/Acetonitrile to 60/40 20 – 25 min Water/Acetonitrile 60/40 25 – 30 min Water/Acetonitrile to 80/20 30 – 35 min Water/Acetonitrile 80/20 (v/v);
0.1 % H3PO4
220 nm 5 µl; 0.0654 mg/ml in
Water/Acetonitrile 50/50 (v/v)
Certificate_ref_substance.indd 4 1/14/2014 12:41:41 PM
-
MM0095.16 lot number 15573 page 6/6
III. Water Content
Method: Karl Fischer titration
Results: Average 0.20 %
Number of results n=3
Standard deviation 0.01 %
IV. Residual Solvents
Method: 1H-NMR
Result: 0.46 % Chloroform
0.04 % n-Hexane
V. Final Result
Total impurities (HPLC) 0.15 %
Water content 0.20 %
Residual solvents 0.50 %
Assay (100 % method)1 99.15 %
The assay is assessed to be 99.2 % ‘as is’
The assay 'as is' is equivalent to the assay based on the not anhydrous and not dried substance respectively.
Release Date: 2012-05-24 LGC GmbH
Dr. Sabine Schröder
Product Release
1 The calculation of the 100 % method follows the formula:
Assay (%) = (100 % - KF - RES) Purity HPLC (%)100 %*
Water (KF) and Residual solvents (RES) are considered as absolute contributions, HPLC purity is considered as relative
contribution.
Certificate_ref_substance.indd 6 1/14/2014 12:41:42 PM
MM0095.16 lot number 15573 page 5/6
Minutes0 5 10 15 20 25 30 35
mA
U
0
100
200
300
400
500
600
mA
U
0
100
200
300
400
500
600
3.66
5.95
8.40
12.7
2
15.1
8
23.0
7
Surveyor PDA 4-220nmRetention Time
Area Percent Report - Sorted by Signal
Pk # Retention Time Area Area % 1 3.66 1422 0.02 2 5.95 2481 0.04 3 8.40 6745401 99.85 4 12.72 1480 0.02 5 15.18 3383 0.05 6 23.07 1693 0.03
Totals 6755860 100.00
For the calculation the system peaks were ignored. The content of the analyte was determined as ratio of
the peak area of the analyte and the cumulative areas of the purities, added up to 100 %.
Results: Average 99.85 %
Number of results n=3
Standard deviation 0.01 %
Certificate_ref_substance.indd 5 1/14/2014 12:41:41 PM
Example certificate of analysis Page 5
MM0095.16 lot number 15573 page 4/6
Ic. IR Spectrum
Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy
The signals of the IR spectrum and their interpretation are consistent with the structural formula.
II. Purity
The purity of the reference substance was analysed by high performance liquid chromatography (HPLC).
HPLC Conditions:
Column: Conditions: Detector: Injector:
Hypersil Gold (C18) 1.0 ml/min, 40 °C DAD Auto
5 µm, 150 x 4.6 mm 0 – 15 min Water/Acetonitrile 80/20 15 – 20 min Water/Acetonitrile to 60/40 20 – 25 min Water/Acetonitrile 60/40 25 – 30 min Water/Acetonitrile to 80/20 30 – 35 min Water/Acetonitrile 80/20 (v/v);
0.1 % H3PO4
220 nm 5 µl; 0.0654 mg/ml in
Water/Acetonitrile 50/50 (v/v)
Certificate_ref_substance.indd 4 1/14/2014 12:41:41 PM
MM0095.16 lot number 15573 page 3/6
Ib. Mass Spectrum
Method: 4.5 kV ESI; vaporization temperature: 200 °C, direct inlet
m/z fragments
376 [ M – H ]
211 [ C8H7N2O3S ]
147 [ C8H7N2O ]
The signals of the mass spectrum and their interpretation are consistent with the structural formula.
Certificate_ref_substance.indd 3 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 2/6
I. Identity
The identity of the reference substance was established by following analyses.
Ia. 1H-NMR Spectrum
Conditions: 400 MHz, DMSO-d6
The structure is confirmed with the signals of the spectrum and their interpretation.
Certificate_ref_substance.indd 2 1/14/2014 12:41:40 PM
6 pages
Catalogue Number: MM0095.16
Lot Number: 15573
Long-term Storage: 2 to 8 °C, dark
Appearance: white solid
Melting Point: 185 °C (dec.)
Assay ‘as is’: 99.2 %
Reference Substance
4-Methoxy-2-[[(5-methoxy-1H-benzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole Sulphone N-Oxide)
N
OS
NH
N
O
OO O
Molecular Formula: C17H19N3O5S Molecular Weight: 377.42 CAS Number: [ 158812-85-2 ]
Date of shipment:
This certificate is valid for two years from the date of shipment provided the substance is stored under the recommended conditions.
Certificate of analysis - impurities reference materials
CERTIFICATE
analysis • consultancy• validation • research
LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, GermanyTel: +49 3371 68 16 80 Fax: +49 3371 68 16 89 Web: www.lgcgroup.com
Certificate_ref_substance.indd 1 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 5/6
Minutes0 5 10 15 20 25 30 35
mA
U
0
100
200
300
400
500
600
mA
U
0
100
200
300
400
500
600
3.66
5.95
8.40
12.7
2
15.1
8
23.0
7
Surveyor PDA 4-220nmRetention Time
Area Percent Report - Sorted by Signal
Pk # Retention Time Area Area % 1 3.66 1422 0.02 2 5.95 2481 0.04 3 8.40 6745401 99.85 4 12.72 1480 0.02 5 15.18 3383 0.05 6 23.07 1693 0.03
Totals 6755860 100.00
For the calculation the system peaks were ignored. The content of the analyte was determined as ratio of
the peak area of the analyte and the cumulative areas of the purities, added up to 100 %.
Results: Average 99.85 %
Number of results n=3
Standard deviation 0.01 %
Certificate_ref_substance.indd 5 1/14/2014 12:41:41 PM
-
MM0095.16 lot number 15573 page 6/6
III. Water Content
Method: Karl Fischer titration
Results: Average 0.20 %
Number of results n=3
Standard deviation 0.01 %
IV. Residual Solvents
Method: 1H-NMR
Result: 0.46 % Chloroform
0.04 % n-Hexane
V. Final Result
Total impurities (HPLC) 0.15 %
Water content 0.20 %
Residual solvents 0.50 %
Assay (100 % method)1 99.15 %
The assay is assessed to be 99.2 % ‘as is’
The assay 'as is' is equivalent to the assay based on the not anhydrous and not dried substance respectively.
Release Date: 2012-05-24 LGC GmbH
Dr. Sabine Schröder
Product Release
1 The calculation of the 100 % method follows the formula:
Assay (%) = (100 % - KF - RES) Purity HPLC (%)100 %*
Water (KF) and Residual solvents (RES) are considered as absolute contributions, HPLC purity is considered as relative
contribution.
Certificate_ref_substance.indd 6 1/14/2014 12:41:42 PM
MM0095.16 lot number 15573 page 5/6
Minutes0 5 10 15 20 25 30 35
mA
U
0
100
200
300
400
500
600
mA
U
0
100
200
300
400
500
600
3.66
5.95
8.40
12.7
2
15.1
8
23.0
7
Surveyor PDA 4-220nmRetention Time
Area Percent Report - Sorted by Signal
Pk # Retention Time Area Area % 1 3.66 1422 0.02 2 5.95 2481 0.04 3 8.40 6745401 99.85 4 12.72 1480 0.02 5 15.18 3383 0.05 6 23.07 1693 0.03
Totals 6755860 100.00
For the calculation the system peaks were ignored. The content of the analyte was determined as ratio of
the peak area of the analyte and the cumulative areas of the purities, added up to 100 %.
Results: Average 99.85 %
Number of results n=3
Standard deviation 0.01 %
Certificate_ref_substance.indd 5 1/14/2014 12:41:41 PM
Example certificate of analysis Page 6
MM0095.16 lot number 15573 page 4/6
Ic. IR Spectrum
Method: Attenuated Total Reflection Fourier Transform Infrared (ATR-FTIR) Spectroscopy
The signals of the IR spectrum and their interpretation are consistent with the structural formula.
II. Purity
The purity of the reference substance was analysed by high performance liquid chromatography (HPLC).
HPLC Conditions:
Column: Conditions: Detector: Injector:
Hypersil Gold (C18) 1.0 ml/min, 40 °C DAD Auto
5 µm, 150 x 4.6 mm 0 – 15 min Water/Acetonitrile 80/20 15 – 20 min Water/Acetonitrile to 60/40 20 – 25 min Water/Acetonitrile 60/40 25 – 30 min Water/Acetonitrile to 80/20 30 – 35 min Water/Acetonitrile 80/20 (v/v);
0.1 % H3PO4
220 nm 5 µl; 0.0654 mg/ml in
Water/Acetonitrile 50/50 (v/v)
Certificate_ref_substance.indd 4 1/14/2014 12:41:41 PM
MM0095.16 lot number 15573 page 3/6
Ib. Mass Spectrum
Method: 4.5 kV ESI; vaporization temperature: 200 °C, direct inlet
m/z fragments
376 [ M – H ]
211 [ C8H7N2O3S ]
147 [ C8H7N2O ]
The signals of the mass spectrum and their interpretation are consistent with the structural formula.
Certificate_ref_substance.indd 3 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 2/6
I. Identity
The identity of the reference substance was established by following analyses.
Ia. 1H-NMR Spectrum
Conditions: 400 MHz, DMSO-d6
The structure is confirmed with the signals of the spectrum and their interpretation.
Certificate_ref_substance.indd 2 1/14/2014 12:41:40 PM
6 pages
Catalogue Number: MM0095.16
Lot Number: 15573
Long-term Storage: 2 to 8 °C, dark
Appearance: white solid
Melting Point: 185 °C (dec.)
Assay ‘as is’: 99.2 %
Reference Substance
4-Methoxy-2-[[(5-methoxy-1H-benzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole Sulphone N-Oxide)
N
OS
NH
N
O
OO O
Molecular Formula: C17H19N3O5S Molecular Weight: 377.42 CAS Number: [ 158812-85-2 ]
Date of shipment:
This certificate is valid for two years from the date of shipment provided the substance is stored under the recommended conditions.
Certificate of analysis - impurities reference materials
CERTIFICATE
analysis • consultancy• validation • research
LGC GmbH, Im Biotechnologiepark, TGZ II, D-14943 Luckenwalde, GermanyTel: +49 3371 68 16 80 Fax: +49 3371 68 16 89 Web: www.lgcgroup.com
Certificate_ref_substance.indd 1 1/14/2014 12:41:40 PM
MM0095.16 lot number 15573 page 6/6
III. Water Content
Method: Karl Fischer titration
Results: Average 0.20 %
Number of results n=3
Standard deviation 0.01 %
IV. Residual Solvents
Method: 1H-NMR
Result: 0.46 % Chloroform
0.04 % n-Hexane
V. Final Result
Total impurities (HPLC) 0.15 %
Water content 0.20 %
Residual solvents 0.50 %
Assay (100 % method)1 99.15 %
The assay is assessed to be 99.2 % ‘as is’
The assay 'as is' is equivalent to the assay based on the not anhydrous and not dried substance respectively.
Release Date: 2012-05-24 LGC GmbH
Dr. Sabine Schröder
Product Release
1 The calculation of the 100 % method follows the formula:
Assay (%) = (100 % - KF - RES) Purity HPLC (%)100 %*
Water (KF) and Residual solvents (RES) are considered as absolute contributions, HPLC purity is considered as relative
contribution.
Certificate_ref_substance.indd 6 1/14/2014 12:41:42 PM
-
LGC impurities according to USP declaration system
Acebutolol Related Compound A (N-(3-Acetyl-4-hydroxyphenyl)butanamide)O
OH
N
H
O
CAS 40188-45-2
M.W. 221.2524
C12
H15
N O3
Producer Code Quantity / Comment
LGC MM 0435.03 100 mg
USP 1000612 20 mg
Acebutolol Related Compound I (N-[3-Acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]
phenyl]butanamide)
O
O N
H
OH
N
H
O
CAS 441019-91-6
M.W. 322.3993
C17
H26
N2
O4
Producer Code Quantity / Comment
LGC MM 0435.09 50 mg
USP 1000699 20 mg
Acetaminophen Related Compound A (4-(Acetylamino)phenyl Acetate (N,O-Diacetyl-4-
aminophenol))
N
H
O
O
O
CAS 2623-33-8
M.W. 193.1992
C10
H11
N O3
Producer Code Quantity / Comment
LGC MM 0042.04 100 mg
USP 1003010 15 mg
Acetaminophen Related Compound B (N-(4-Hydroxyphenyl)-propanamide (N-Propionyl-4
-aminophenol))
N
H
O
OH
CAS 1693-37-4
M.W. 165.1891
C9
H11
N O2
Producer Code Quantity / Comment
LGC MM 0042.05 100 mg
USP 1003027 30 mg
Acetaminophen Related Compound C (N-(2-Hydroxyphenyl)-acetamide (2-
Acetamidophenol))
N
H
O
OH
CAS 614-80-2
M.W. 151.1626
C8
H9
N O2
Producer Code Quantity / Comment
LGC MM 0042.08 100 mg
USP 1003031 50 mg
Acetaminophen Related Compound D (N-Phenylacetamide (Acetanilide))
N
H
O
CAS 103-84-4
M.W. 135.1632
C8
H9
N O
Producer Code Quantity / Comment
LGC MM 0042.10 100 mg
USP 1003042 50 mg
Acetaminophen Related Compound F (4-Nitrophenol)
N
+
O
O
OH
CAS 100-02-7
M.W. 139.1088
C6
H5
N O3
Producer Code Quantity / Comment
LGC MM 0042.03 100 mg
USP 1003064 50 mg
[email protected] don't find what you are looking for? Suggest a reference standard by emailing
Visit us at www.lgcstandards.com.1
Symyx 05261514092D 1 1.00000 0.00000 0
16 16 0 0 0 999 V2000 6.0713 2.1148 0.0000 C 0 0 0 0 0 0 0 0 0 6.0713 0.7044 0.0000 C 0 0 0 0 0 0 0 0 0 7.2851 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 8.4990 0.7044 0.0000 C 0 0 0 0 0 0 0 0 0 8.4990 2.1148 0.0000 C 0 0 0 0 0 0 0 0 0 7.2851 2.8193 0.0000 C 0 0 0 0 0 0 0 0 0 7.2851 4.2193 0.0000 C 0 0 0 0 0 0 0 0 0 6.0727 4.9193 0.0000 O 0 0 0 0 0 0 0 0 0 8.4976 4.9193 0.0000 C 0 0 0 0 0 0 0 0 0 9.7122 2.8135 0.0000 O 0 0 0 0 0 0 0 0 0 4.8581 0.0058 0.0000 N 0 0 0 0 0 0 0 0 0 3.6373 0.7106 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 0.0106 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 2.1106 0.0000 O 0 0 0 0 0 0 0 0 0 1.2124 0.7106 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 0.0106 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 1 6 1 0 0 0 6 7 1 0 0 0 7 8 2 0 0 0 7 9 1 0 0 0 5 10 1 0 0 0 2 11 1 0 0 0 11 12 1 0 0 0 12 13 1 0 0 0 12 14 2 0 0 0 13 15 1 0 0 0 15 16 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
23 23 0 0 0 999 V2000 6.0713 2.1148 0.0000 C 0 0 0 0 0 0 0 0 0 6.0713 0.7044 0.0000 C 0 0 0 0 0 0 0 0 0 7.2851 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 8.4990 0.7044 0.0000 C 0 0 0 0 0 0 0 0 0 8.4990 2.1148 0.0000 C 0 0 0 0 0 0 0 0 0 7.2851 2.8193 0.0000 C 0 0 0 0 0 0 0 0 0 7.2851 4.2193 0.0000 C 0 0 0 0 0 0 0 0 0 6.0727 4.9193 0.0000 O 0 0 0 0 0 0 0 0 0 8.4976 4.9193 0.0000 C 0 0 0 0 0 0 0 0 0 9.7122 2.8135 0.0000 O 0 0 0 0 0 0 0 0 0 10.9238 2.1121 0.0000 C 0 0 0 0 0 0 0 0 0 12.1371 2.8108 0.0000 C 0 0 3 0 0 0 0 0 0 13.3487 2.1094 0.0000 C 0 0 0 0 0 0 0 0 0 12.1386 4.2108 0.0000 O 0 0 0 0 0 0 0 0 0 14.5619 2.8080 0.0000 N 0 0 0 0 0 0 0 0 0 15.7736 2.1067 0.0000 C 0 0 0 0 0 0 0 0 0 16.9868 2.8053 0.0000 C 0 0 0 0 0 0 0 0 0 4.8581 0.0058 0.0000 N 0 0 0 0 0 0 0 0 0 3.6373 0.7106 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 0.0106 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 2.1106 0.0000 O 0 0 0 0 0 0 0 0 0 1.2124 0.7106 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 0.0106 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 1 6 1 0 0 0 6 7 1 0 0 0 7 8 2 0 0 0 7 9 1 0 0 0 5 10 1 0 0 0 10 11 1 0 0 0 11 12 1 0 0 0 12 13 1 0 0 0 12 14 1 0 0 0 13 15 1 0 0 0 15 16 1 0 0 0 16 17 1 0 0 0 2 18 1 0 0 0 18 19 1 0 0 0 19 20 1 0 0 0 19 21 2 0 0 0 20 22 1 0 0 0 22 23 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
14 14 0 0 0 999 V2000 6.0869 2.1589 0.0000 C 0 0 0 0 0 0 0 0 0 7.2925 2.8494 0.0000 N 0 0 0 0 0 0 0 0 0 8.4980 2.1589 0.0000 C 0 0 0 0 0 0 0 0 0 4.8616 2.8494 0.0000 C 0 0 0 0 0 0 0 0 0 3.6462 2.1589 0.0000 C 0 0 0 0 0 0 0 0 0 3.6462 0.7589 0.0000 C 0 0 0 0 0 0 0 0 0 4.8616 0.0296 0.0000 C 0 0 0 0 0 0 0 0 0 6.0869 0.7589 0.0000 C 0 0 0 0 0 0 0 0 0 9.7043 2.8494 0.0000 C 0 0 0 0 0 0 0 0 0 8.4980 0.7589 0.0000 O 0 0 0 0 0 0 0 0 0 2.4308 0.0296 0.0000 O 0 0 0 0 0 0 0 0 0 1.2055 0.7103 0.0000 C 0 0 0 0 0 0 0 0 0 1.2055 2.1103 0.0000 O 0 0 0 0 0 0 0 0 0 0.0000 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 1 0 0 0 2 3 1 0 0 0 1 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 6 7 1 0 0 0 7 8 2 0 0 0 1 8 1 0 0 0 3 9 1 0 0 0 3 10 2 0 0 0 6 11 1 0 0 0 11 12 1 0 0 0 12 13 2 0 0 0 12 14 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
12 12 0 0 0 999 V2000 3.6561 2.1292 0.0000 C 0 0 0 0 0 0 0 0 0 4.8616 2.8198 0.0000 N 0 0 0 0 0 0 0 0 0 6.0672 2.1292 0.0000 C 0 0 0 0 0 0 0 0 0 2.4308 2.8198 0.0000 C 0 0 0 0 0 0 0 0 0 1.2154 2.1292 0.0000 C 0 0 0 0 0 0 0 0 0 1.2154 0.7292 0.0000 C 0 0 0 0 0 0 0 0 0 2.4308 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6561 0.7292 0.0000 C 0 0 0 0 0 0 0 0 0 7.2735 2.8198 0.0000 C 0 0 0 0 0 0 0 0 0 6.0672 0.7292 0.0000 O 0 0 0 0 0 0 0 0 0 0.0000 0.0000 0.0000 O 0 0 0 0 0 0 0 0 0 8.4790 2.1194 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 1 0 0 0 2 3 1 0 0 0 1 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 6 7 1 0 0 0 7 8 2 0 0 0 1 8 1 0 0 0 3 9 1 0 0 0 3 10 2 0 0 0 6 11 1 0 0 0 9 12 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
11 11 0 0 0 999 V2000 1.2147 2.8000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4264 2.0987 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 0.6987 0.0000 C 0 0 0 0 0 0 0 0 0 1.2117 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 0.7013 0.0000 C 0 0 0 0 0 0 0 0 0 0.0015 2.1013 0.0000 C 0 0 0 0 0 0 0 0 0 1.2162 4.2000 0.0000 O 0 0 0 0 0 0 0 0 0 4.8512 2.0961 0.0000 C 0 0 0 0 0 0 0 0 0 4.8497 0.6961 0.0000 O 0 0 0 0 0 0 0 0 0 6.0644 2.7948 0.0000 C 0 0 0 0 0 0 0 0 0 3.6396 2.7974 0.0000 N 0 0 0 0 0 0 0 0 0 1 2 1 0 0 0 2 3 2 0 0 0 3 4 1 0 0 0 4 5 2 0 0 0 5 6 1 0 0 0 1 6 2 0 0 0 1 7 1 0 0 0 8 9 2 0 0 0 8 10 1 0 0 0 8 11 1 0 0 0 2 11 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
10 10 0 0 0 999 V2000 2.4407 2.1292 0.0000 C 0 0 0 0 0 0 0 0 0 3.6462 2.8198 0.0000 N 0 0 0 0 0 0 0 0 0 4.8518 2.1292 0.0000 C 0 0 0 0 0 0 0 0 0 1.2154 2.8198 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 2.1292 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 0.7292 0.0000 C 0 0 0 0 0 0 0 0 0 1.2154 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4407 0.7292 0.0000 C 0 0 0 0 0 0 0 0 0 6.0581 2.8296 0.0000 C 0 0 0 0 0 0 0 0 0 4.8518 0.7292 0.0000 O 0 0 0 0 0 0 0 0 0 1 2 1 0 0 0 2 3 1 0 0 0 1 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 6 7 1 0 0 0 7 8 2 0 0 0 1 8 1 0 0 0 3 9 1 0 0 0 3 10 2 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
10 10 0 0 0 999 V2000 3.6393 2.1195 0.0000 C 0 0 0 0 0 0 0 0 0 4.8393 2.8068 0.0000 N 0 3 0 0 0 0 0 0 0 4.8393 4.2068 0.0000 O 0 0 0 0 0 0 0 0 0 6.0518 2.1068 0.0000 O 0 5 0 0 0 0 0 0 0 2.4197 2.8068 0.0000 C 0 0 0 0 0 0 0 0 0 1.2098 2.1195 0.0000 C 0 0 0 0 0 0 0 0 0 1.2098 0.7259 0.0000 C 0 0 0 0 0 0 0 0 0 2.4197 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6393 0.7259 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 0.0000 0.0000 O 0 0 0 0 0 0 0 0 0 1 2 1 0 0 0 1 5 2 0 0 0 5 6 1 0 0 0 6 7 2 0 0 0 7 8 1 0 0 0 8 9 2 0 0 0 1 9 1 0 0 0 7 10 1 0 0 0 2 3 2 0 0 0 2 4 1 0 0 0M CHG 2 2 1 4 -1M END
http://www.lgcstandards.com/GB/en/search/?searchPropertyName=code&text=MM0042.03mailto:[email protected]://www.lgcstandards.com
-
LGC impurities according to USP declaration system
Acetaminophen Related Compound J (N-(4-Chlorophenyl)acetamide (4-
Chloroacetanilide))
N
H
O
Cl
CAS 539-03-7
M.W. 169.6082
C8
H8
Cl N O
Producer Code Quantity / Comment
LGC MM 0042.02 100 mg
USP 1003100 50 mg
Acetyl Simvastatin ((1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-(Acetyloxy)-6-oxotetrahydro-2H-
pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-
Dimethylbutanoate)
O
O
O
O
H
O O
CAS 145576-25-6
M.W. 460.6029
C27
H40
O6
Producer Code Quantity / Comment
LGC MM 0158.02 100 mg
USP 1010208 30 mg
Acyclovir Related Compound A (2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]
ethyl Acetate)
N
NH
O
NH2
N
N
O
O
O
CAS 102728-64-3
M.W. 267.2413
C10
H13
N5
O4
Producer Code Quantity / Comment
LGC MM 0061.01 100 mg
USP 1012076 50 mg
Acyclovir Related Compound F (N-[9-[(2-Hydroxyethoxy)-methyl]-6-oxo-6,9-dihydro-1H-
purin-2-yl]acetamide)
N
NH
O
N
H
O
N
N
O
OH
CAS 110104-37-5
M.W. 267.2413
C10
H13
N5
O4
Producer Code Quantity / Comment
LGC MM 0061.06 100 mg
USP 1012054 50 mg
Acyclovir Related Compound G (2-[[(2-(Acetylamino)-6-oxo-1,6-dihydro-9H-purin-9-yl]-
methoxy]ethyl Acetate)
N
NH
O
N
H
O
N
N
O
O
O
CAS 75128-73-3
M.W. 309.278
C12
H15
N5
O5
Producer Code Quantity / Comment
LGC MM 0061.07 100 mg
USP 1012087 50 mg
Adapalene Related Compound C (1-(2-Methoxyphenyl)tricyclo[3.3.1.13,7]decane)
O
CAS 43109-77-9
M.W. 242.356
C17
H22
O
Producer Code Quantity / Comment
LGC MM 0681.01 50 mg
USP 1011732 25 mg
Adapalene Related Compound D (1,1'-[4,4'Bis(methoxy)biphenyl-3,3'-diyl]bis(tricyclo
[3.3.1.13,7]decane))
O
O
CAS 932033-57-3
M.W. 482.6961
C34
H42
O2
Producer Code Quantity / Comment
LGC MM 0681.02 50 mg
USP 1011743 25 mg
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Symyx 05261514092D 1 1.00000 0.00000 0
11 11 0 0 0 999 V2000 3.6561 2.1292 0.0000 C 0 0 0 0 0 0 0 0 0 4.8616 2.8198 0.0000 N 0 0 0 0 0 0 0 0 0 6.0672 2.1292 0.0000 C 0 0 0 0 0 0 0 0 0 2.4308 2.8198 0.0000 C 0 0 0 0 0 0 0 0 0 1.2154 2.1292 0.0000 C 0 0 0 0 0 0 0 0 0 1.2154 0.7292 0.0000 C 0 0 0 0 0 0 0 0 0 2.4308 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6561 0.7292 0.0000 C 0 0 0 0 0 0 0 0 0 7.2735 2.8198 0.0000 C 0 0 0 0 0 0 0 0 0 6.0672 0.7292 0.0000 O 0 0 0 0 0 0 0 0 0 0.0000 0.0000 0.0000 Cl 0 0 0 0 0 0 0 0 0 1 2 1 0 0 0 2 3 1 0 0 0 1 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 6 7 1 0 0 0 7 8 2 0 0 0 1 8 1 0 0 0 3 9 1 0 0 0 3 10 2 0 0 0 6 11 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
34 36 0 1 0 999 V2000 1.2154 3.5004 0.0000 C 0 0 0 0 0 0 0 0 0 1.2154 2.0996 0.0000 C 0 0 0 0 0 0 0 0 0 2.4209 1.4000 0.0000 C 0 0 1 0 0 0 0 0 0 3.6265 2.0996 0.0000 C 0 0 0 0 0 0 0 0 0 3.6265 3.5004 0.0000 C 0 0 1 0 0 0 0 0 0 2.4209 4.2000 0.0000 C 0 0 2 0 0 0 0 0 0 2.4209 5.5909 0.0000 C 0 0 2 0 0 0 0 0 0 1.2154 6.2806 0.0000 C 0 0 2 0 0 0 0 0 0 0.0000 5.5909 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 1.2154 7.6814 0.0000 C 0 0 0 0 0 0 0 0 0 3.6265 4.9004 0.0000 H 0 0 0 0 0 0 0 0 0 2.4209 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 4.8419 4.2000 0.0000 O 0 0 0 0 0 0 0 0 0 6.0573 3.5004 0.0000 C 0 0 0 0 0 0 0 0 0 7.2727 4.2000 0.0000 O 0 0 0 0 0 0 0 0 0 6.0573 2.0996 0.0000 C 0 0 3 0 0 0 0 0 0 4.8419 1.4000 0.0000 C 0 0 0 0 0 0 0 0 0 7.2727 1.4000 0.0000 C 0 0 0 0 0 0 0 0 0 6.0573 0.6996 0.0000 C 0 0 0 0 0 0 0 0 0 8.4881 2.0996 0.0000 C 0 0 0 0 0 0 0 0 0 3.6265 6.2806 0.0000 C 0 0 0 0 0 0 0 0 0 4.8419 5.5909 0.0000 C 0 0 0 0 0 0 0 0 0 6.0573 6.2806 0.0000 C 0 0 2 0 0 0 0 0 0 7.2727 5.5909 0.0000 C 0 0 0 0 0 0 0 0 0 8.4881 6.2806 0.0000 C 0 0 2 0 0 0 0 0 0 8.4881 7.6814 0.0000 C 0 0 0 0 0 0 0 0 0 7.2727 8.3810 0.0000 C 0 0 0 0 0 0 0 0 0 6.0573 7.6814 0.0000 O 0 0 0 0 0 0 0 0 0 7.2727 9.7810 0.0000 O 0 0 0 0 0 0 0 0 0 9.6936 5.5909 0.0000 O 0 0 0 0 0 0 0 0 0 10.9091 6.2905 0.0000 C 0 0 0 0 0 0 0 0 0 10.9091 7.6905 0.0000 O 0 0 0 0 0 0 0 0 0 12.1245 5.5909 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 1 0 0 0 4 5 1 0 0 0 5 6 1 0 0 0 1 6 1 0 0 0 6 7 1 0 0 0 7 8 1 0 0 0 8 9 1 0 0 0 9 10 2 0 0 0 1 10 1 0 0 0 8 11 1 6 0 0 6 12 1 6 0 0 3 13 1 1 0 0 5 14 1 1 0 0 14 15 1 0 0 0 15 16 2 0 0 0 15 17 1 0 0 0 17 18 1 0 0 0 17 19 1 0 0 0 17 20 1 0 0 0 19 21 1 0 0 0 7 22 1 6 0 0 22 23 1 0 0 0 24 23 1 1 0 0 24 25 1 0 0 0 25 26 1 0 0 0 26 27 1 0 0 0 27 28 1 0 0 0 28 29 1 0 0 0 24 29 1 0 0 0 28 30 2 0 0 0 26 31 1 6 0 0 31 32 1 0 0 0 32 33 2 0 0 0 32 34 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
19 20 0 0 0 999 V2000 5.4090 -3.9603 0.0000 C 0 0 0 0 0 0 0 0 0 5.4090 -5.1463 0.0000 C 0 0 0 0 0 0 0 0 0 4.3878 -5.7396 0.0000 N 0 0 0 0 0 0 0 0 0 3.3665 -5.1463 0.0000 C 0 0 0 0 0 0 0 0 0 3.3665 -3.9603 0.0000 N 0 0 0 0 0 0 0 0 0 4.3878 -3.3670 0.0000 C 0 0 0 0 0 0 0 0 0 6.5294 -3.5981 0.0000 N 0 0 0 0 0 0 0 0 0 7.2135 -4.5530 0.0000 C 0 0 0 0 0 0 0 0 0 6.5294 -5.4925 0.0000 N 0 0 3 0 0 0 0 0 0 4.3878 -2.1810 0.0000 O 0 0 0 0 0 0 0 0 0 2.3369 -5.7396 0.0000 N 0 0 0 0 0 0 0 0 0 7.1227 -6.5054 0.0000 C 0 0 0 0 0 0 0 0 0 8.3003 -6.5054 0.0000 O 0 0 0 0 0 0 0 0 0 8.8936 -5.4925 0.0000 C 0 0 0 0 0 0 0 0 0 10.0713 -5.4925 0.0000 C 0 0 0 0 0 0 0 0 0 10.6645 -4.4706 0.0000 O 0 0 0 0 0 0 0 0 0 11.8506 -4.4706 0.0000 C 0 0 0 0 0 0 0 0 0 12.4438 -3.4410 0.0000 C 0 0 0 0 0 0 0 0 0 12.4438 -5.5002 0.0000 O 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 1 0 0 0 1 6 1 0 0 0 1 7 1 0 0 0 7 8 2 0 0 0 8 9 1 0 0 0 2 9 1 0 0 0 6 10 2 0 0 0 4 11 1 0 0 0 9 12 1 0 0 0 12 13 1 0 0 0 13 14 1 0 0 0 14 15 1 0 0 0 15 16 1 0 0 0 16 17 1 0 0 0 17 18 1 0 0 0 17 19 2 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
19 20 0 0 0 999 V2000 6.0725 3.0168 0.0000 C 0 0 0 0 0 0 0 0 0 6.0725 1.6110 0.0000 C 0 0 0 0 0 0 0 0 0 4.8620 0.9077 0.0000 N 0 0 0 0 0 0 0 0 0 3.6514 1.6110 0.0000 C 0 0 0 0 0 0 0 0 0 3.6514 3.0168 0.0000 N 0 0 0 0 0 0 0 0 0 4.8620 3.7193 0.0000 C 0 0 0 0 0 0 0 0 0 7.4005 3.4462 0.0000 N 0 0 0 0 0 0 0 0 0 8.2113 2.3135 0.0000 C 0 0 0 0 0 0 0 0 0 7.4005 1.2006 0.0000 N 0 0 3 0 0 0 0 0 0 4.8620 5.1259 0.0000 O 0 0 0 0 0 0 0 0 0 2.4310 0.9077 0.0000 N 0 0 0 0 0 0 0 0 0 8.1038 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 9.4997 0.0000 0.0000 O 0 0 0 0 0 0 0 0 0 10.2030 1.2006 0.0000 C 0 0 0 0 0 0 0 0 0 11.5989 1.2006 0.0000 C 0 0 0 0 0 0 0 0 0 12.3021 2.4112 0.0000 O 0 0 0 0 0 0 0 0 0 1.2105 1.6110 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 0.8978 0.0000 C 0 0 0 0 0 0 0 0 0 1.2006 3.0168 0.0000 O 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 1 0 0 0 1 6 1 0 0 0 1 7 1 0 0 0 7 8 2 0 0 0 8 9 1 0 0 0 2 9 1 0 0 0 6 10 2 0 0 0 4 11 1 0 0 0 9 12 1 0 0 0 12 13 1 0 0 0 13 14 1 0 0 0 14 15 1 0 0 0 15 16 1 0 0 0 11 17 1 0 0 0 17 18 1 0 0 0 17 19 2 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
22 23 0 0 0 999 V2000 6.0733 2.9970 0.0000 C 0 0 0 0 0 0 0 0 0 6.0733 1.6110 0.0000 C 0 0 0 0 0 0 0 0 0 4.8620 0.9077 0.0000 N 0 0 0 0 0 0 0 0 0 3.6514 1.6110 0.0000 C 0 0 0 0 0 0 0 0 0 3.6514 2.9970 0.0000 N 0 0 0 0 0 0 0 0 0 4.8620 3.7002 0.0000 C 0 0 0 0 0 0 0 0 0 7.4005 3.4462 0.0000 N 0 0 0 0 0 0 0 0 0 8.2113 2.3135 0.0000 C 0 0 0 0 0 0 0 0 0 7.4005 1.2006 0.0000 N 0 0 3 0 0 0 0 0 0 4.8620 5.1061 0.0000 O 0 0 0 0 0 0 0 0 0 2.4310 0.9077 0.0000 N 0 0 0 0 0 0 0 0 0 8.1038 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 9.4997 0.0000 0.0000 O 0 0 0 0 0 0 0 0 0 10.2030 1.2006 0.0000 C 0 0 0 0 0 0 0 0 0 11.5988 1.2006 0.0000 C 0 0 0 0 0 0 0 0 0 12.3021 2.4111 0.0000 O 0 0 0 0 0 0 0 0 0 1.2105 1.6110 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 0.9077 0.0000 C 0 0 0 0 0 0 0 0 0 1.2105 2.9970 0.0000 O 0 0 0 0 0 0 0 0 0 13.7079 2.4020 0.0000 C 0 0 0 0 0 0 0 0 0 14.4211 3.6125 0.0000 O 0 0 0 0 0 0 0 0 0 14.4013 1.1815 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 1 0 0 0 1 6 1 0 0 0 1 7 1 0 0 0 7 8 2 0 0 0 8 9 1 0 0 0 2 9 1 0 0 0 6 10 2 0 0 0 4 11 1 0 0 0 9 12 1 0 0 0 12 13 1 0 0 0 13 14 1 0 0 0 14 15 1 0 0 0 15 16 1 0 0 0 11 17 1 0 0 0 17 18 1 0 0 0 17 19 2 0 0 0 16 20 1 0 0 0 20 21 2 0 0 0 20 22 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
18 21 0 0 0 999 V2000 0.0000 2.1000 0.0000 C 0 0 3 0 0 0 0 0 0 0.0000 0.7000 0.0000 C 0 0 0 0 0 0 0 0 0 1.2124 0.0000 0.0000 C 0 0 3 0 0 0 0 0 0 2.4249 0.7000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 2.1000 0.0000 C 0 0 3 0 0 0 0 0 0 1.2124 2.8000 0.0000 C 0 0 0 0 0 0 0 0 0 1.2308 2.1206 0.0000 C 0 0 0 0 0 0 0 0 0 1.2308 1.4000 0.0000 C 0 0 3 0 0 0 0 0 0 0.7000 0.9082 0.0000 C 0 0 0 0 0 0 0 0 0 1.8301 1.0271 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 2.8000 0.0000 C 0 0 0 0 0 0 0 0 0 4.8497 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 6.0622 2.8000 0.0000 C 0 0 0 0 0 0 0 0 0 6.0622 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 4.8497 4.9000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 4.9000 0.0000 O 0 0 0 0 0 0 0 0 0 1.2124 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 1 0 0 0 2 3 1 0 0 0 3 4 1 0 0 0 4 5 1 0 0 0 5 6 1 0 0 0 6 1 1 0 0 0 5 7 1 0 0 0 7 8 1 0 0 0 1 9 1 0 0 0 9 8 1 0 0 0 3 10 1 0 0 0 10 8 1 0 0 0 5 11 1 0 0 0 11 12 2 0 0 0 12 13 1 0 0 0 13 14 2 0 0 0 14 15 1 0 0 0 15 16 2 0 0 0 16 11 1 0 0 0 16 17 1 0 0 0 17 18 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
36 43 0 0 0 999 V2000 0.0000 2.1000 0.0000 C 0 0 3 0 0 0 0 0 0 0.0000 0.7000 0.0000 C 0 0 0 0 0 0 0 0 0 1.2124 0.0000 0.0000 C 0 0 3 0 0 0 0 0 0 2.4249 0.7000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 2.1000 0.0000 C 0 0 3 0 0 0 0 0 0 1.2124 2.8000 0.0000 C 0 0 0 0 0 0 0 0 0 1.2308 2.0856 0.0000 C 0 0 0 0 0 0 0 0 0 1.2308 1.4000 0.0000 C 0 0 3 0 0 0 0 0 0 0.7000 0.9082 0.0000 C 0 0 0 0 0 0 0 0 0 1.8301 1.0271 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 2.8000 0.0000 C 0 0 0 0 0 0 0 0 0 4.8497 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 6.0622 2.8000 0.0000 C 0 0 0 0 0 0 0 0 0 6.0622 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 4.8497 4.9000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 4.9000 0.0000 O 0 0 0 0 0 0 0 0 0 1.2124 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 7.2746 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 7.2746 0.7000 0.0000 C 0 0 0 0 0 0 0 0 0 8.4871 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 9.6995 0.7000 0.0000 C 0 0 0 0 0 0 0 0 0 9.6995 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 8.4871 2.8000 0.0000 C 0 0 0 0 0 0 0 0 0 13.3368 2.8000 0.0000 C 0 0 3 0 0 0 0 0 0 13.3368 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 12.1244 4.9000 0.0000 C 0 0 3 0 0 0 0 0 0 10.9119 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 12.1244 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 12.1060 2.7794 0.0000 C 0 0 0 0 0 0 0 0 0 12.1060 3.5000 0.0000 C 0 0 3 0 0 0 0 0 0 12.6368 3.9918 0.0000 C 0 0 0 0 0 0 0 0 0 11.5067 3.8729 0.0000 C 0 0 0 0 0 0 0 0 0 10.9119 0.0000 0.0000 O 0 0 0 0 0 0 0 0 0 12.1244 0.7000 0.0000 C 0 0 0 0 0 0 0 0 0 10.9119 2.8000 0.0000 C 0 0 3 0 0 0 0 0 0 1 2 1 0 0 0 2 3 1 0 0 0 3 4 1 0 0 0 4 5 1 0 0 0 5 6 1 0 0 0 6 1 1 0 0 0 5 7 1 0 0 0 7 8 1 0 0 0 1 9 1 0 0 0 9 8 1 0 0 0 3 10 1 0 0 0 10 8 1 0 0 0 5 11 1 0 0 0 11 12 2 0 0 0 12 13 1 0 0 0 13 14 2 0 0 0 14 15 1 0 0 0 15 16 2 0 0 0 16 11 1 0 0 0 16 17 1 0 0 0 17 18 1 0 0 0 13 19 1 0 0 0 19 20 2 0 0 0 20 21 1 0 0 0 21 22 2 0 0 0 22 23 1 0 0 0 23 24 2 0 0 0 24 19 1 0 0 0 25 26 1 0 0 0 26 27 1 0 0 0 27 28 1 0 0 0 28 36 1 0 0 0 36 29 1 0 0 0 29 25 1 0 0 0 36 30 1 0 0 0 30 31 1 0 0 0 25 32 1 0 0 0 32 31 1 0 0 0 27 33 1 0 0 0 33 31 1 0 0 0 22 34 1 0 0 0 34 35 1 0 0 0 23 36 1 0 0 0M END
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-
LGC impurities according to USP declaration system
Adapalene Related Compound E (2,2'-Binaphthalene-6,6'-dicarboxylic Acid)
OH
O
O
O H
CAS 932033-58-4
M.W. 342.3442
C22
H14
O4
Producer Code Quantity / Comment
LGC MM 0681.03 50 mg
USP 1011754 25 mg
Albuterol Related Compound A ((1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4-hydroxy-3-
methylphenyl)ethanol) N
H
OH
OH
CAS 18910-68-4
M.W. 223.3113
C13
H21
N O2
Producer Code Quantity / Comment
LGC MM 0381.03 50 mg
USP 1012644 25 mg
Allopurinol Related Compound A (5-Amino-1H-pyrazole-4-carboxamide Hemisulphate)
2
N H2
O
N
N
H
N H2
S
O
O
OH OH
CAS 27511-79-1
M.W. 350.3118
2 C4
H6
N4
O . H2
O4
S
Producer Code Quantity / Comment
LGC MM 0034.01 100 mg
USP 1013024 25 mg
Allopurinol Related Compound D (Ethyl 5-Amino-1H-pyrazole-4-carboxylate)
O
O
N
N
H
N H2
CAS 6994-25-8
M.W. 155.1546
C6
H9
N3
O2
Producer Code Quantity / Comment
LGC MM 0034.05 100 mg
USP 1013046 35 mg
Allopurinol Related Compound E (Ethyl 5-(Formylamino)-1H-pyrazole-4-carboxylate)
O
O
N
N
H
N
H
O
CAS 31055-19-3
M.W. 183.1647
C7
H9
N3
O3
Producer Code Quantity / Comment
LGC MM 0034.06 100 mg
USP 1013068 25 mg
Amiloride Related Compound A (Methyl 3,5-Diamino-6-chloropyrazine-2-carboxylate)
N
N
O
O
N H2
NH2
Cl
CAS 1458-01-1
M.W. 202.5984
C6
H7
Cl N4
O2
Producer Code Quantity / Comment
LGC MM 0560.01 100 mg
USP 1019712 30 mg
4-Aminobenzoic Acid
OH
O
NH2
CAS 150-13-0
M.W. 137.136
C7
H7
N O2
Producer Code Quantity / Comment
LGC MM 0094.03 100 mg
USP 1019803 200 mg
4-Aminobenzoylglutamic Acid ((2S)-2-[(4-Aminobenzoyl)amino]pentanedioic Acid)
N
H
OH
O
O OH
O
NH2
CAS 4271-30-1
M.W. 266.25
C12
H14
N2
O5
Producer Code Quantity / Comment
LGC MM 0621.01 100 mg
USP 1019870 50 mg
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Symyx 05261514092D 1 1.00000 0.00000 0
26 29 0 0 0 999 V2000 9.6995 3.5000 0.0000 C 0 0 0 0 0 0 0 0 0 10.9119 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 10.9119 5.6000 0.0000 C 0 0 0 0 0 0 0 0 0 9.6995 6.3000 0.0000 C 0 0 0 0 0 0 0 0 0 8.4870 5.6000 0.0000 C 0 0 0 0 0 0 0 0 0 8.4870 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 7.2746 6.3000 0.0000 C 0 0 0 0 0 0 0 0 0 6.0622 5.6000 0.0000 C 0 0 0 0 0 0 0 0 0 4.8497 6.3000 0.0000 C 0 0 0 0 0 0 0 0 0 4.8497 7.7000 0.0000 C 0 0 0 0 0 0 0 0 0 6.0622 8.4000 0.0000 C 0 0 0 0 0 0 0 0 0 7.2746 7.7000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 5.6000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 6.3000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 7.7000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 8.4000 0.0000 C 0 0 0 0 0 0 0 0 0 1.2124 8.4000 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 7.7000 0.0000 O 0 0 0 0 0 0 0 0 0 1.2124 9.8000 0.0000 O 0 0 0 0 0 0 0 0 0 9.6995 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 10.9119 1.4000 0.0000 C 0 0 0 0 0 0 0 0 0 12.1244 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 12.1244 3.5000 0.0000 C 0 0 0 0 0 0 0 0 0 13.3368 1.4000 0.0000 C 0 0 0 0 0 0 0 0 0 13.3368 0.0000 0.0000 O 0 0 0 0 0 0 0 0 0 14.5492 2.1000 0.0000 O 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 6 1 1 0 0 0 5 7 1 0 0 0 7 8 2 0 0 0 8 9 1 0 0 0 9 10 2 0 0 0 10 11 1 0 0 0 11 12 2 0 0 0 12 7 1 0 0 0 9 13 1 0 0 0 13 14 2 0 0 0 14 15 1 0 0 0 15 16 2 0 0 0 16 10 1 0 0 0 15 17 1 0 0 0 17 18 1 0 0 0 17 19 2 0 0 0 1 20 1 0 0 0 20 21 2 0 0 0 21 22 1 0 0 0 22 23 2 0 0 0 23 2 1 0 0 0 22 24 1 0 0 0 24 25 2 0 0 0 24 26 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
16 16 0 0 0 999 V2000 1.2147 3.4985 0.0000 C 0 0 0 0 0 0 0 0 0 1.2147 2.0985 0.0000 C 0 0 0 0 0 0 0 0 0 2.4196 1.3992 0.0000 C 0 0 0 0 0 0 0 0 0 3.6245 2.0985 0.0000 C 0 0 0 0 0 0 0 0 0 3.6245 3.4985 0.0000 C 0 0 0 0 0 0 0 0 0 2.4196 4.1977 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 1.3992 0.0000 O 0 0 0 0 0 0 0 0 0 2.4196 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 4.8393 4.1977 0.0000 C 0 0 3 0 0 0 0 0 0 6.0540 3.4985 0.0000 C 0 0 0 0 0 0 0 0 0 4.8393 5.5970 0.0000 O 0 0 0 0 0 0 0 0 0 7.2688 4.1977 0.0000 N 0 0 0 0 0 0 0 0 0 8.4835 3.4985 0.0000 C 0 0 3 0 0 0 0 0 0 9.6983 4.1977 0.0000 C 0 0 0 0 0 0 0 0 0 8.4835 2.0985 0.0000 C 0 0 0 0 0 0 0 0 0 9.6983 2.7985 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 1 6 1 0 0 0 2 7 1 0 0 0 3 8 1 0 0 0 5 9 1 0 0 0 9 10 1 0 0 0 9 11 1 0 0 0 10 12 1 0 0 0 12 13 1 0 0 0 13 14 1 0 0 0 13 15 1 0 0 0 13 16 1 0 0 0M END
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Symyx 05261514092D 1 1.00000 0.00000 0
23 22 0 0 0 999 V2000 7.6092 -5.3692 0.0000 C 0 0 0 0 0 0 0 0 0 7.6092 -4.1875 0.0000 C 0 0 0 0 0 0 0 0 0 8.6346 -3.5973 0.0000 C 0 0 0 0 0 0 0 0 0 9.6682 -4.1875 0.0000 N 0 0 0 0 0 0 0 0 0 8.6346 -5.9677 0.0000 N 0 0 0 0 0 0 0 0 0 6.4935 -5.7300 0.0000 N 0 0 0 0 0 0 0 0 0 5.8129 -4.7784 0.0000 N 0 0 0 0 0 0 0 0 0 6.4935 -3.8434 0.0000 C 0 0 0 0 0 0 0 0 0 8.6346 -2.4162 0.0000 O 0 0 0 0 0 0 0 0 0 13.8382 -4.7545 0.0000 S 0 0 3 0 0 0 0 0 0 13.8382 -5.9356 0.0000 O 0 0 0 0 0 0 0 0 0 13.8382 -3.5734 0.0000 O 0 0 0 0 0 0 0 0 0 12.6571 -4.7545 0.0000 O 0 0 0 0 0 0 0 0 0 15.0193 -4.7545 0.0000 O 0 0 0 0 0 0 0 0 0 7.6092 -5.3692 0.0000 C 0 0 0 0 0 0 0 0 0 7.6092 -4.1875 0.0000 C 0 0 0 0 0 0 0 0 0 8.6346 -3.5973 0.0000 C 0 0 0 0 0 0 0 0 0 9.6682 -4.1875 0.0000 N 0 0 0 0 0 0 0 0 0 8.6346 -5.9677 0.0000 N 0 0 0 0 0 0 0 0 0 6.4935 -5.7300 0.0000 N 0 0 0 0 0 0 0 0 0 5.8129 -4.7784 0.0000 N 0 0 0 0 0 0 0 0 0 6.4935 -3.8434 0.0000 C 0 0 0 0 0 0 0 0 0 8.6346 -2.4162 0.0000 O 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 1 0 0 0 1 5 1 0 0 0 6 1 1 0 0 0 6 7 1 0 0 0 7 8 2 0 0 0 8 2 1 0 0 0 9 3 2 0 0 0 10 11 2 0 0 0 10 12 2 0 0 0 10 13 1 0 0 0 10 14 1 0 0 0 15 16 2 0 0 0 16 17 1 0 0 0 17 18 1 0 0 0 15 19 1 0 0 0 20 15 1 0 0 0 20 21 1 0 0 0 21 22 2 0 0 0 22 16 1 0 0 0 23 17 2 0 0 0M STY 1 1 MULM SLB 1 1 1M SCN 1 1 HTM SAL 1 15 1 2 3 4 5 6 7 8 9 15 16 17 18 19 20M SAL 1 3 21 22 23M SPA 1 9 1 2 3 4 5 6 7 8 9M SMT 1 2M SDI 1 4 10.6498 -2.0386 10.6498 -6.5828M SDI 1 4 5.3814 -6.5828 5.3814 -2.0386M END
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Symyx 05261514092D 1 1.00000 0.00000 0
11 11 0 0 0 999 V2000 2.1292 0.7095 0.0000 C 0 0 0 0 0 0 0 0 0 2.1292 2.1103 0.0000 C 0 0 0 0 0 0 0 0 0 3.3447 2.8099 0.0000 C 0 0 0 0 0 0 0 0 0 4.5699 2.1103 0.0000 O 0 0 0 0 0 0 0 0 0 3.3447 0.0000 0.0000 N 0 0 0 0 0 0 0 0 0 0.8067 0.2818 0.0000 N 0 0 0 0 0 0 0 0 0 0.0000 1.4099 0.0000 N 0 0 0 0 0 0 0 0 0 0.8067 2.5182 0.0000 C 0 0 0 0 0 0 0 0 0 3.3447 4.2099 0.0000 O 0 0 0 0 0 0 0 0 0 5.7853 2.8099 0.0000 C 0 0 0 0 0 0 0 0 0 6.9909 2.1103 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 1 0 0 0 1 5 1 0 0 0 6 1 1 0 0 0 6 7 1 0 0 0 7 8 2 0 0 0 8 2 1 0 0 0 9 3 2 0 0 0 4 10 1 0 0 0 10 11 1 0 0 0M END
http://www.lgcstandards.com/GB/en/search/?searchPropertyName=code&text=MM0034.05
Symyx 05261514092D 1 1.00000 0.00000 0
13 13 0 0 0 999 V2000 2.1281 0.7091 0.0000 C 0 0 0 0 0 0 0 0 0 2.1281 2.1091 0.0000 C 0 0 0 0 0 0 0 0 0 3.3428 2.8083 0.0000 C 0 0 0 0 0 0 0 0 0 4.5675 2.1091 0.0000 O 0 0 0 0 0 0 0 0 0 3.3428 0.0000 0.0000 N 0 0 0 0 0 0 0 0 0 0.8063 0.2817 0.0000 N 0 0 0 0 0 0 0 0 0 0.0000 1.4091 0.0000 N 0 0 0 0 0 0 0 0 0 0.8063 2.5168 0.0000 C 0 0 0 0 0 0 0 0 0 3.3428 4.2076 0.0000 O 0 0 0 0 0 0 0 0 0 5.7822 2.8083 0.0000 C 0 0 0 0 0 0 0 0 0 6.9871 2.1091 0.0000 C 0 0 0 0 0 0 0 0 0 4.5576 0.7000 0.0000 C 0 0 0 0 0 0 0 0 0 5.7723 0.0000 0.0000 O 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 1 0 0 0 1 5 1 0 0 0 6 1 1 0 0 0 6 7 1 0 0 0 7 8 2 0 0 0 8 2 1 0 0 0 9 3 2 0 0 0 4 10 1 0 0 0 10 11 1 0 0 0 5 12 1 0 0 0 12 13 2 0 0 0M END
http://www.lgcstandards.com/GB/en/search/?searchPropertyName=code&text=MM0034.06
Symyx 05261514092D 1 1.00000 0.00000 0
13 13 0 0 0 999 V2000 1.2124 2.1033 0.0000 C 0 0 0 0 0 0 0 0 0 1.2124 0.7011 0.0000 C 0 0 0 0 0 0 0 0 0 2.4268 0.0000 0.0000 N 0 0 0 0 0 0 0 0 0 3.6411 0.7011 0.0000 C 0 0 0 0 0 0 0 0 0 3.6411 2.1033 0.0000 C 0 0 0 0 0 0 0 0 0 2.4268 2.8044 0.0000 N 0 0 0 0 0 0 0 0 0 0.0000 2.8033 0.0000 Cl 0 0 0 0 0 0 0 0 0 4.8536 0.0011 0.0000 N 0 0 0 0 0 0 0 0 0 4.8536 2.8033 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 0.0011 0.0000 N 0 0 0 0 0 0 0 0 0 6.0660 2.1033 0.0000 O 0 0 0 0 0 0 0 0 0 4.8536 4.2033 0.0000 O 0 0 0 0 0 0 0 0 0 7.2784 2.8033 0.0000 C 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 6 1 1 0 0 0 1 7 1 0 0 0 4 8 1 0 0 0 5 9 1 0 0 0 2 10 1 0 0 0 9 11 1 0 0 0 9 12 2 0 0 0 11 13 1 0 0 0M END
http://www.lgcstandards.com/GB/en/search/?searchPropertyName=code&text=MM0560.01
Symyx 05261514092D 1 1.00000 0.00000 0
10 10 0 0 0 999 V2000 1.2118 0.7020 0.0000 C 0 0 0 0 0 0 0 0 0 2.4254 0.0000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6371 0.6996 0.0000 C 0 0 0 0 0 0 0 0 0 3.6353 2.1012 0.0000 C 0 0 0 0 0 0 0 0 0 2.4273 2.7951 0.0000 C 0 0 0 0 0 0 0 0 0 1.2156 2.0955 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 0.0024 0.0000 N 0 0 0 0 0 0 0 0 0 4.8478 2.8012 0.0000 C 0 0 0 0 0 0 0 0 0 6.0607 2.0989 0.0000 O 0 0 0 0 0 0 0 0 0 4.8459 4.2029 0.0000 O 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 1 6 1 0 0 0 1 7 1 0 0 0 4 8 1 0 0 0 8 9 1 0 0 0 8 10 2 0 0 0M END
http://www.lgcstandards.com/GB/en/search/?searchPropertyName=code&text=MM0094.03
Symyx 05261514092D 1 1.00000 0.00000 0
19 19 0 1 0 999 V2000 1.2124 3.5000 0.0000 C 0 0 0 0 0 0 0 0 0 1.2124 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 1.4000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 3.6373 3.5000 0.0000 C 0 0 0 0 0 0 0 0 0 2.4249 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 0.0000 1.4000 0.0000 N 0 0 0 0 0 0 0 0 0 4.8497 4.2000 0.0000 C 0 0 0 0 0 0 0 0 0 6.0622 3.5000 0.0000 N 0 0 0 0 0 0 0 0 0 4.8497 5.6000 0.0000 O 0 0 0 0 0 0 0 0 0 7.2746 4.2000 0.0000 C 0 0 1 0 0 0 0 0 0 8.4870 3.5000 0.0000 C 0 0 0 0 0 0 0 0 0 8.4870 2.1000 0.0000 C 0 0 0 0 0 0 0 0 0 9.6995 1.4000 0.0000 C 0 0 0 0 0 0 0 0 0 10.9119 2.1000 0.0000 O 0 0 0 0 0 0 0 0 0 9.6995 0.0000 0.0000 O 0 0 0 0 0 0 0 0 0 7.2746 5.6000 0.0000 C 0 0 0 0 0 0 0 0 0 6.0622 6.3000 0.0000 O 0 0 0 0 0 0 0 0 0 8.4870 6.3000 0.0000 O 0 0 0 0 0 0 0 0 0 1 2 2 0 0 0 2 3 1 0 0 0 3 4 2 0 0 0 4 5 1 0 0 0 5 6 2 0 0 0 6 1 1 0 0 0 2 7 1 0 0 0 5 8 1 0 0 0 8 9 1 0 0 0 8 10 2 0 0 0 9 11 1 0 0 0 11 12 1 0 0 0 12 13 1 0 0 0 13 14 1 0 0 0 14 15 1 0 0 0 14 16 2 0 0 0 11 17 1 6 0 0 17 18 2 0 0 0 17 19 1 0 0 0M END
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LGC impurities according to USP declaration system
2-Amino-5-chlorobenzophenoneN H
2
O
Cl
CAS 719-59-5
M.W. 231.6776
C13
H10
Cl N O
Producer Code Quantity / Comment
LGC MM 0028.03 100 mg
USP 1022808 25 mg
4-Aminophenol
NH2
OH
CAS 123-30-8
M.W. 109.1259
C6
H7
N O
Producer