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Catalog of Reference Materials for Pharmaceutical Analysis for Materials Catalog of Reference a Catalog of Reference Materials for Pharmaceutical Analysis 2007 - 2008 Edition 2007 First Choice for Quality Introduction European Pharmacopoeia...............................................................................................4 British Pharmacopoeia .................................................................................................. 38 International Pharmacopeia ........................................................................................ 47 United States Pharmacopeia ....................................................................................... 51 Pharmacopée Française ................................................................................................ 84 Contents Pharmacopeia Helvetica ............................................................................................... 86 Japanese Pharmacopoeia ............................................................................................ 87 Pharmaceutical Impurities ........................................................................................... 91 Other Pharmaceuticals Certified Viscosity Standards ..............................................................................144 Institute of Dyes and Organic Products (IBPO) .............................................145 International Commission on Pharmaceutical Enzymes ..........................146 Refractive Index CRMs ...........................................................................................147 Pharmaceutical Publications ...............................................................................148 Updates to the Catalog...................................................................................At the End Ordering Information....................................................................... Inside Back Cover First Choice for Quality Introduction About Resource Technology Corporation (RTC) Established in 1988, we are an importer and distributor of Pharmaceutical Reference Standards and Substances from the European Pharmacopoeia (EP), British Pharmacopoeia (BP) and other major Pharmacopoeias and pharmaceutical reference standards producers from around the world. Our expertise in the importation process for these materials can save customers time, expense, and frustration, and result in timely and efficient delivery. Because we are located in the United States, it is easy to place and to follow up an order by telephone, fax, email or even by mail. All orders are billed in U.S. Dollars, eliminating the cost and problems of currency fluctuation and conversion. We have all the necessary permits and registrations to broker orders through U.S. Customs, FDA, USDA, DEA, Home Land Security and other agencies. We have offices located near the major pharmacopoeias to expedite delivery. Custom Packaging and Evaluation Services RTC has recently completed construction of modern laboratory and production facilities and offers custom Pharmaceutical Reference Standard services to in-house secondary standards producers and laboratory users. We can work with material supplied by the client or procure third party materials. Services include: ¾ Vialing: crimp-top or screw-cap; multiple sizes. ¾ Ampuling: 2 mL, 5 mL, 10 mL, or 20 mL pre-scored amber ampules; Nitrogen or Argon blanketed. ¾ Container closure validation studies. ¾ Analytical evaluation studies. Full characterization Traceability to compendial reference materials Accelerated stability ¾ Toxic and hazardous chemical handling. ¾ Clean room capabilities. ¾ GMP batch record and Certificate of Analysis provided as appropriate. Each service contract is developed in close collaboration with the client. Projects are specifically designed according to the customer’s needs and specifications. Confidentiality is maintained at all times. For information about theses services or to discuss you needs, contact: Alan Nichols e-mail: [email protected] <mailto:[email protected]> Tel: 800-576-5690 or 307-742-5452 Fax : 307-745-7936 About the Catalog This is the Resource Technology Corporation (RTC) Catalog of Reference Materials for Pharmaceutical Analysis. This catalog replaces the Catalog of Reference Materials for Pharmaceutical Analysis 2005 Edition, and all subsequent updates. The information provided in the catalog is based on the “official” pharmacopoeial lists in January, 2007 and is correct at the time of print. Original descriptions and spellings used by the producers have been retained. New products become available continuously and official pharmacopoeial lots change as current lots deplete. A regularly updated version of this catalog is available from our website at http://www.RT-Corp.com, where pages can be reviewed and downloaded for printing. Please check periodically for the latest information. Pharmaceutical Reference Standards Certification The products described in this catalog include Pharmaceutical Reference Standards (or Substances) for use in pharmaceutical analysis. Pharmaceutical Reference Standards 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. Pharmaceutical Reference Standards are produced for a specific purpose, and manufacturers follow rigorous protocols to ensure that they are fit for the intended purpose. The certification processes follows the basic requirements of the relevant ISO REMCO Guides but are modified by the pharmacopoeia to reflect the particular demands of the associated pharmaceutical monograph. Details are given in the introduction to each section listing the various Pharmaceutical Reference Standards collections in this catalog. The production of Pharmacopoeial Reference Standards and Substances is specifically addressed in ISO Guide 34 (Second Edition, 2000): “Pharmacopoeial standards and substances are established and distributed by pharmacopoeial authorities following the general principles of this Guide. It should be noted, however, that a different approach is used by the pharmacopoeial authorities to give the user the information provided by certificates of analysis and expiration dates. Also, the uncertainty of their assigned values is not stated since it is negligible in relation to the defined limits of the method-specific assays of the pharmacopoeias for which they are used.” Shelf Life, Storage and Expiration Dates Pharmaceutical Reference Standards 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 container should not be kept for future use. Please refer to product labels and/or accompanying documentation for appropriate short term storage conditions. Specific lot numbers or letters are allocated to all Pharmaceutical Reference Standards, but no expiration dates are assigned by the Pharmacopoeias. 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 been depleted, a final expiration date is provided; any material from the outgoing lot held by users must be used by the given date. This means that for a period of time both lots are “official.” If a material is withdrawn by the producer, then all stocks held by the users must be destroyed. Please note that such a situation is outside our control, and product prices are not refundable. Impurity Standards Impurities in a pharmaceutical substance can significantly change the effects and side effects of a drug. Therefore, it is important to have an accurate detection of impurities. The pharmaceutical monographs regulate the legal definition, the analysis and limits of impurities of a given substance. Official impurity standards are available from the Pharmacopoeia where required in monographs. Other impurity standards are listed in the Pharmaceutical Impurities section of this catalog. Controlled Substances A number of Pharmaceutical Reference Standards, notably narcotics, tranquilizers and drugs of abuse, described in this catalog are considered Controlled Substances in the United States and/or in their country of origin. Those that are controlled in the United States are marked Controlled Substance beside the product description along with their Schedule of control assigned by the United States Drug Enforcement Administration. The purchase, possession and use of Controlled Substances are subject to national and international regulation designed to limit their abuse. Before ordering, it is the responsibility of the customer to obtain any authorization necessary to purchase and to possess Controlled Substances, in compliance with the laws of the importing country. Customers wishing to obtain Controlled Substances must contact RTC before ordering to clarify with the sales representative 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 authorized person. The order must be accompanied with a copy of the original import permit and/or possession permit. Use, Safety and Handling Please read any documents supplied with the product before opening or using it. Pay particular attention to instructions referring to premixing, addition of diluent to lyophilized material, and to the