LGC Standards Pharmacopoeial Reference Standards 2014
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LL CTS INKSP RODUTO A L P ITH W WEBSHO LGC Standards Pharmacopoeial reference standards 2014 FOR STANDARDS WITH CofA SEE OUR CATALOGUE: PHARMACEUTICAL IMPURITIES AND PRIMARY REFERENCE STANDARDS LGC Quality – ISO Guide 34 • GMP/GLP • ISO 9001 • ISO/IEC 17025 • ISO/IEC 17043 Pharmaceutical impurities Code Product CAS No. CS Price Unit Adiphenine Hydrochloride O LGC Standards N O MM1172.00 Adiphenine Hydrochloride 50-42-0 A 250mg HCl Pharmaceutical impurities and Adrenaline Tartrate OH H OH O OH primary reference standardsMM0614.00 2014 N OH Adrenaline Tartrate 51-42-3 A 500mg OH OH O OH OH H MM0614.02 L-Adrenaline 51-43-4 A 500mg OH N OH Imp. C (EP) as Hydrochloride: 1-(3,4-Di- O H OH MM0614.13 hydroxyphenyl)-2-(methylamino)ethanone 62-13-5 A 100mg N HCl Hydrochloride (Adrenalone Hydrochloride) OH (1R)-1-(3,4-Dihydroxyphenyl)-2- OH O S O MM0614.01 methylaminoethanesulphonic Acid H 78995-75-2 A 100mg OH N (Adrenaline -Sulphonate) OH Alanine NH2 MM0566.00 Alanine 56-41-7 A 500mg OH O Imp. A (Pharmeuropa): (2 S)-2-Aminobutanedioic Acid O NH 2 MM0567.00 OH (Aspartic Acid) 56-84-8 A 500mg OH O Albendazole O H MM0382.00 Albendazole N O 54965-21-8 A 500mg N H S N Imp. A (EP): 5-(Propylsulphanyl)-1H- H MM0382.01 N 80983-36-4 A 100mg NH2 benzimidazol-2-amine S N O H Imp. B (EP): Methyl [5-Propylsulphinyl)- N O MM0382.02 N 54029-12-8 A 100mg H 1H-benzimidazol-2-yl]carbamate S N O O H Imp. C (EP): Methyl [5-Propylsulphonyl)- N O MM0382.03 N 75184-71-3 A 100mg H 1H-benzimidazol-2-yl]carbamate S N OO H Imp. D (EP): 5-(Propylsulphonyl) -1H- N MM0382.04 NH 80983-34-2 A 100mg 2 benzimidazol-2-amine S N OO O Imp. E (EP): Methyl (1H-Benzimidazol-2- H MM2500.00 10605-21-7 N O yl)carbamate (Carbendazim) A 100mg N N H Alfuzosin Hydrochloride O N Cl ISOImp. Guide B (EP): 34 • 2-Chloro-6,7-dimethoxyquinazolin- GMP/GLP • ISO 9001 • ISO/IEC 17025 • ISO/IEC 17043 MM0085.04 23680-84-4 N 4-amine A 100mg O LGC Quality – NH2 Imp. D (EP) as Dihydrochloride: N-(4-Amino-6,7- O N NNH 2 MM1004.04 dimethoxyquinazolin-2-yl)-N-methylpropane-1,3- HCl N n/a 2 A 50mg O diamine Dihydrochloride NH2 Request yourVisit us at www.lgcstandards.com copy now! 6’ Print_LGC_Katalog_MM_2013-11-27_NoHyperlink_v04j.pdf 6 20/01/2014 15:55:39 Also available from LGC Standards: ‘Pharmaceutical impurities and primary reference standards 2014 A comprehensive catalogue of more than 3,000 pharmaceutical impurities and primary reference standards manufactured by LGC.. www.lgcstandards.com Contact your local LGC Standards office for your free copy, or download@LGCStdsPharma a PDF version of this catalogue at www.lgcstandards.com 3970/LB/0514 Visit us at ISO Guide 34 • GMP/GLP • ISO 9001 • ISO/IEC 17025 • ISO/IEC 17043 LGC Quality - © LGC Limited, 2014. All rights reserved. LGC Standards is part of the LGC Group. WITH LINKS TO ALL WEBSHOP PRODUCTS Introduction @LGCStdsPharma www.lgcstandards.com Buy pharmaceutical reference materials online 56,000 one reference intuitive your search standard materials engine Our website offers the+ most comprehensive source of= reference materials - now available for ONLINE ordering. Anyone can browse product information online, simply visit: www.lgcstandards.com To view pricing and to place an order, please register at: www.lgcstandards.com/register For further information visit www.lgcstandards.com or contact your local office. LGC Quality - ISO Guide 34 • GMP/GLP • ISO 9001 • ISO/IEC 17025 • ISO/IEC 17043 © LGC Limited, 2013. All rights reserved. LGC Standards is part of the LGC Group. 3664/LB/0713 3677_standards_webshop_ad_v4.indd 1 1/14/2014 5:40:43 PM Contents Introduction ���������������������������������������������������������������������������������������������������������������������������������������� 6 European Pharmacopoeia ��������������������������������������������������������������������������������������������������������������� 11 United States Pharmacopoeia ��������������������������������������������������������������������������������������������������������� 77 British Pharmacopoeia and others ����������������������������������������������������������������������������������������������� 161 Complementary products ������������������������������������������������������������������������������������������������������������� 189 Email: [email protected] | Website: www.lgcstandards.com 5 3970_1Pharma_catalogue_internal_pages_v2.indd 5 6/12/2014 12:04:33 PM Introduction Welcome to the new edition of our pharmacopoeial reference standards catalogue� About LGC Standards LGC Standards has successfully established a global reputation for the production of impurities and working standards, and as a single source for the supply of pharmacopeia reference materials� Our menu of custom services, including custom synthesis of impurities and metabolites, characterisation, certification, packaging and distribution, adds value to the scientific support we provide to our pharmaceutical customers� Our relationships with the world’s leading pharmacopoeias and their range of Chemical Reference Substances (CRS) and Reference Standards (RS), combined with in-house production of primary reference standards and pharmaceutical impurities, enable us to meet our customers’ specific needs. LGC Standards is also the exclusive European distributor for ATCC cultures and bio products� LGC Standards’ extensive network of sales offices and distribution centres means we offer the widest range of reference materials from one single source for rapid delivery� Our staff can provide scientific and technical guidance, including shipping and customs advice, in the local language. Our range of products also includes reference materials for clinical and forensic applications, phytochemicals, environmental analysis, physical properties determination, and food and beverage analysis� For more information about our range of services, or to receive any of our catalogues, please refer to our website www�lgcstandards�com or contact your local office. About LGC LGC is an international life sciences measurement and testing company, which builds upon leading positions in sustainably growing markets. LGC provides reference materials, proficiency testing, genomics and analytical products and services which underpin the safety, health and security of the public to customers in the Pharmaceutical, Agricultural Bioscience, Food and Environment, Government and Academia, Security and Sports markets. With headquarters in Teddington, South West London, LGC employs over 2,000 staff, operating out of 22 countries worldwide. Its operations are extensively accredited to international quality standards such as ISO/IEC 17025 and ISO Guide 34. With a history dating back to 1842, LGC has been home to the UK Government Chemist for more than 100 years. It is the designated UK National Measurement Institute for Chemical and Bioanalytical measurement, providing metrology research, calibration and testing� LGC was privatised in 1996 and is now majority-owned by funds managed by Bridgepoint� For more information, please visit www�lgcgroup�com 6 Email: [email protected] | Website: www.lgcstandards.com 3970_1Pharma_catalogue_internal_pages_v2.indd 6 6/12/2014 12:04:33 PM About the catalogue This catalogue comprises the reference standards from the major pharmacopoeias, plus ready to use reagents as they are outlined in the chapters 2 and 4 of the European Pharmacopoeia and further complementary products� For our own range of primary and impurity reference standards, please refer to the current catalogue “Pharmaceutical impurities and primary reference standards”. It is also available for download from our website. The information provided in this catalogue as regards compendial articles is based on the ‘official’ pharmacopoeial lists and is correct at the time of print� Original descriptions and spellings used by the producers are retained� Pharmaceutical reference substances Certification The products described in this catalogue include pharmacopeial reference substances for use in pharmaceutical analysis. Pharmacopeial CRS and RS should be distinguished from certified reference materials (CRM), which are produced in conformity with the ISO guides 30 to 35, and supplied with a detailed certification document. Pharmacopeial reference substances are produced for a specific purpose, and the manufacturers follow rigorous protocols to ensure the reference substance is fit for the intended purpose. The ‘certification’ processes follow the basic requirements of the relevant ISO REMCO guides, but are modified by the pharmacopoeias to reflect the particular demands of the associated pharmacopeial monograph� Details are given in the introduction to each section listing the various CRS/RS collections in this catalogue� Shelf life, storage, expiry dates and unit sizes Pharmacopeial CRS and RS should be purchased when required and not stored for a prolonged period� Pack sizes are designed to allow a limited number of replicate analyses, as required by Good Analytical Practice, but the opened pack should not be kept for future use. Please check all individual storage temperature requirements and note that the substances should be kept away from humidity and light (unless otherwise stated)� Specific lot numbers or letters are allocated to all pharmacopeial reference substances, but no expiry dates are set. New lots are normally prepared well in advance of the expected ‘sell-out’ of the current lot� Please note that new lots can have different unit sizes, especially with pharmacopoeial reference standards, and LGC Standards