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The International Pharmacopoeia contains a collection of recommended methods for analysis and quality specifications for pharmaceutical substances, excipients and products. This new edition consolidates the texts of the five separate volumes of the third edition and includes new monographs for antiretroviral substances (didanosine, indinavir sulfate, nelfinavir mesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate) adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations in October 2004. It includes some additions and amendments to the general notices of the Pharmacopoeia, as well as some changes to its layout and format. Volume one contains monographs for pharmaceutical substances A to O and the General Notices; and volume two contains monographs for pharmaceutical substances P to Z, together with those for dosage forms and radiopharmaceutical preparations, the methods of analysis and reagents.
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This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
Chinese Pharmacopoeia 2010 is an official and authoritative compendium of drugs. It covers most traditional Chinese medicines, most western medicines and preparations, giving information on the standards of purity, description, test, dosage, precaution, storage, and the strength for each drug. It is published in three volumes, and contains up to 4567 monographs with 1386 new admissions. In Volume I, it contains monographs of Chinese crude drugs and the prepared slices. Vegetable oil/fat and its extract, the patented Chinese traditional medicines, single ingredient of Chinese crude drug preparations etc. it has 2165 monographs with 1019 new admissions (439 articles of the prepared slice) and 634 revised; Volume II deals with monographs of chemical drugs, antibiotics, biochemical preparations, radiopharmaceuticals and excipients for pharmaceutical use, contains 2271 monographs with 330 new admissions and 1500 revised; Volume III contains biological products, has 131 monographs with 37 new admissions and 94 revised
The USP-NF is a combination of two official compendia, the United States Pharmacopeia (USP) and the National Formulary (NF). It contains standards for medicines, dosage forms, drug substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and other therapeutics. USP-NF standards are enforceable by the U.S. Food and Drug Administration for medicines manufactured and marketed in the United States. Learn more about USP-NF. Highlights & Features: * More than 4,500 monographs with specifications for identity, strength, quality, purity, packaging, and labeling for substances and dosage forms. View a sample USP-NF monograph (100KB). * Over 230 General Chapters providing clear, step-by-step guidance for assays, tests, and procedures * Focus-specific charts and a combined index helps you find the information you need * Helpful sections on reagents, indicators, and solutions, plus reference tables * Published annually in an official English edition (print, CD, and new USB flash drive formats ) and an official Spanish edition (print).