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Pharmaceutical Reference Substances and Impurities

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Pharmaceutical Reference Substances and Impurities Pharmaceutical reference substances and impurities 2006 / 2007 Contents Contents Introduction Introduction 3 Publications and subscriptions 5 United States Pharmacopeia and National Formulary 9 ATCC microbiological products 57 European Pharmacopoeia 55 ATCC microbiological products 108 Certified liquids for viscosity measurements 110 International commission on pharmaceutical enzymes 111 European Pharmacopoeia reagents 112 British Pharmacopoeia 117 ATCC microbiological products 130 Pharmacopée Française 132 Pharmacopoeia Helvetica 134 International Pharmacopeia 135 Institute of Dyes and Organic products 141 Refractive index CRMs 144 Pharmaceutical impurities 145 Background 147 Certificate of Analysis 148 List of products 151 High purity solvents 315 We are grateful to Medizin- und Apothekenhistorisches Museum Rhede e.V. for the supply of many of the photographic images in this catalogue. www.mam-rhede.de Edition 2006/2007 All your needs for pharmaceutical analysis - email [email protected] 1 Contents We constantly add new products to our range, so please call us to find out about new products and services and to make sure you are automatically kept up to date by subscribing to our free newsletter. Just send an email to [email protected] 2 All your needs for pharmaceutical analysis - email [email protected] Edition 2006/2007 List of LGC Promochem offices Introduction France • Germany • India • Italy • Poland • Spain • Sweden • UK List of LGC Promochem offices France Poland United Kingdom - Japan (Head office) LGC Promochem LGC Promochem - Korea 6, Rue Kastler ul. M. Konopnickiej 1 LGC Promochem - Macau B.P.76 Dziekanów Lesny Queens Road - Netherlands 67123 Molsheim 05-092 Lomianki Teddington - Romania France Poland Middlesex - Russia TW11 0LY Tel +33 (0)3 88 04 82 82 - Slovenia Tel +48 (0)22 751 31 40 United Kingdom Fax +33 (0)3 88 04 82 90 - Switzerland Fax +48 (0)22 751 58 45 Email [email protected] - Thailand Email [email protected] Tel +44 (0)20 8943 7565 - Turkey Fax +44 (0)20 8943 7554 Countries served Countries served Email - Algeria - Belorussia India [email protected] - Belgium - Lithuania - France LGC Promochem - Poland Countries served - Ivory Coast P.O. Box 8061 - Slovakia - Australia - Jordan No.142, 3rd Floor, 5th Cross - Ukraine - Brunei - Lebanon Rajmahal Vilas Extension - Canada - Libya Bangalore 560 080 Spain - Channel Islands - Madagascar India - Ireland LGC Promochem - Morocco - Kenya Tel +91 (0)80 2361 1256 C/Salvador Espriu 59, 2º planta - Senegal - Kuwait Fax +91 (0)80 2361 3859 08005 Barcelona - Syria - Malta Email [email protected] Spain - Tanzania - New Zealand - Tunisia Countries served Tel +34 93 308 4181 - Philippines - Bangladesh Fax +34 93 307 3612 - Saudi Arabia Germany - India Email [email protected] - South Africa - Malaysia - United Arab Emirates LGC Promochem Countries served - Nepal - United Kingdom Mercatorstrasse 51 - Andorra - Pakistan 46485 Wesel - Portugal - Spain Germany Italy - Latin America Tel +49 (0)281 9887 0 LGC Promochem s.r.l. Fax +49 (0)281 9887 199 Via Venezia, 23 Sweden Email [email protected] 20099 Sesto San Giovanni LGC Promochem Countries served Milan Box 1737 - Austria Italy SE-501 17 Borås - Bulgaria Tel +39 02 2412 6830 Sweden - China (Hong Kong, Singapore) Fax +39 02 2412 6831 - Croatia Tel +46 (0)33 20 90 60 Email [email protected] - Cyprus Fax +46 (0)33 20 90 79 - Czech Republic Countries served Email [email protected] - Egypt - Italy Countries served - Germany - Denmark - Greece - Estonia - Hungary - Finland - Iran - Iceland - Israel - Latvia - Norway - Sweden Your LGC Promochem account number Your contact at LGC Promochem is Name: Tel: Fax: www.lgcpromochem.com Email: For countries not listed above, please contact our head office. Introduction Introduction About LGC Promochem LGC Promochem is the leading reference materials supplier in Europe. Our relationships with the world’s leading pharmacopeias and their range of Chemical Reference Substances (CRS) and Reference Standards (RS), combined with in-house production of a wide variety of certified reference materials and pharmaceutical impurities, enable us to meet the often exacting needs of our customers. LGC Promochem’s network of offices across Europe and India and experience in reference materials distribution allow us to provide faster delivery, local technical support and assistance with import requirements. LGC Promochem's range of products also includes reference materials for clinical and forensic applications, phytochemicals, environmental analysis, determination of physical properties, and for food and beverage analysis. LGC Promochem is also the exclusive European distributor for ATCC cultures and bioproducts. For more information about our range of services or to receive any of our catalogues, please refer to our website www.lgcpromochem.com or contact your local office. About the catalogue The 2006/2007 edition of the LGC Promochem catalogue ‘Pharmaceutical reference substances and impurities’, replaces the ‘Pharmaceutical reference substances and impurities’ 2005/2006 edition and the three newsletter updates. 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. In some cases additional information has been included to make the lists more convenient to use. A regularly updated version of this catalogue is available from the LGC Promochem website at www.lgcpromochem.com, where pages can be reviewed and downloaded for printing. Pharmaceutical reference substances Certification The products described in this catalogue include pharmacopeial reference substances for use in pharmaceutical analysis. Pharmacopeial CRSs and RSs should be distinguished from certified reference materials (CRMs), 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 pharmaceutical monograph. Details are given in the introduction to each section listing the various CRS collections in this catalogue. Shelf Life, storage and expiry dates Pharmacopeial CRSs and RSs 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. When a substance is withdrawn from sale because the lot has depleted a final expiry date is given, by which any material from the outgoing lot held by users must be used. This means that for a period of time both lots are ‘official’. Lot information is provided by USP and EP in their literature and is available from LGC Promochem. If a material is withdrawn by the producer, then all stocks held by the users are no longer valid and have to be destroyed. Should this occur, LGC Promochem will inform all customers who have purchased the withdrawn substance. Please note that such a situation is outside LGC Promochem’s control and products are not refundable. Edition 2006/2007 All your needs for pharmaceutical analysis - email [email protected] 3 Pharmaceutical reference substances Impurity standards Impurities in a pharmaceutical substance can change the effects and side effects of a drug significantly. Therefore, it is important to have an accurate detection of impurities. The pharmaceutical monographs regulate the legal definition, the analysis and the limits of impurities of a given substance. An official range of impurity standards is available from the main pharmacopoeias where a CRS or RS is required in the monograph. Other impurity standards are listed in the ‘pharmaceutical impurities’ section of the catalogue. Controlled substances A number of the pharmaceutical substances, such as narcotics and tranquillisers, described in this catalogue are Controlled Substances in their country of origin and are marked ‘Controlled Substance’ against the product description. The purchase, possession and use of Controlled Substances are subject to national and international regulations designed to limit their abuse. It is the responsibility of the customer to obtain any authorisation necessary to both purchase and possess Controlled Substances, complying with the laws of the importing country, before ordering. Customers wishing to obtain Controlled Substances must contact their LGC Promochem sales office before ordering, and clarify with the sales specialists the relevant national requirements, the associated charges and consequential delivery times. All orders for Controlled Substances must be provided in writing and signed by an authorised person. The orders must be accompanied with the original import permit and/or possession
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