pharmacopoeia.pdfVIP

Pharmacopoeia (literally, drug-making ) What A book or encyclopedia of ……  Published under the jurisdiction of …  Ch P– Chinese Pharmacopoeia(2010)  USP-NF – The United States Pharmacopoeia-The National Formulaary(USP36-NF31)  BP– British Pharmacopoeia (2011) JP– Japanese Pharmacopoeia 日本药 局方  Ph. Eup– European Pharmacopoeia  Ph. Int– The International Pharmacopoeia ChP2010 Volume one for Chinese medicines Volume two for chemical drugs Volume three for biological products 凡例 General Notice 正文 ChP Monograph 附录appendices 索引 index USP-NF A book of pharmacopoeial standards It contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. USP in U.S. Law  USP standards are recognized in a variety of U.S. federal legislation.  USP’s drug standards are specified in the adulteration and misbranding provisions of the FDCA  More than 200 FDA regulations incorporate USP food ingredient standards. USP  First edition: December 15, 1820  Second edition: 1830  Next each edition at 10-year intervals up to 1842.  Next each edition at 5-year intervals from 1942 to 2000. After 2000,annually. USP-NF  In 1975,USP acquired the National Formulary and began publishing both compendia in a single volume, titled USP- NF. The USP-NF and its supplements will become official six months after being released to the public.  It is released on Nov.1 of each year