国内外药典药包材标准是我国药品与药包材关联审评重要依据之一。 目前, 影响较大的国外药典如«美国药典»(United States Pharmacopeia, USP)、«欧洲药典»(European Pharmacopeia, EP)、«日本药局方» (Japanese Pharmacopeia, JP)等均已收载药包材标准。 美国食品药品管理局(FDA)对药包材采取药品主文件(...
USP官方释义1USP harmonizes pharmacopeial excipient monographs and general chapters through the Pharmacopeial Discussion Group (PDG), which includes representatives from the European, Japanese, and United States pharmacopeias and WHO (as an observer). According to the PDG definition, "a pharmacopeial gene...
联系方式: General Chapters at gc@usp.org United States Pharmacopeia 12601 Twinbrook Parkway Rockville, MD 20852 ▲
in General Notices, a monograph, or a general chapter numbered below 1000. General chapters ...
美国药典-国家处方集(U.S. Pharmacopeia / National Formulary)(USP-NF) 是由美国政府所属的美国药典委员会(The United States Pharmacopeial Convention)编辑出版的关于药典标准的公开出版物。它包含关于药物、剂型、原料药、辅料、医疗器械和食物补充剂的标准。美国药典-国家处方集每年出版一次,目前已经出版到第37版(...
C. BurgessJ.P. HammondSpectroscopy EuropeModernisation of the spectroscopic general chapters in the United States Pharmacopeia. BURGESS C,HAMMOND J P. Spectroscopy Letters . 2015
美国药典-国家处方集（U.S. Pharmacopeia / National Formulary）(USP-NF) 是由美国政府所属的美国药典...
在USP37-NF32 第二增补本的凡例(General Notice)中“2.OFFICIAL STATUS AND LEGAL RECOGNITION”项下有如下规定: “2.10. Official Text Official text is text contained in USP and NF, including monographs, general chapters, and these General Notices. Revisions to...
General Chapters provide in summary form the basic guidelines for the interpretation and application of the standards tests assays and other specifications of the United States Pharmacopeia and eliminate the need to repeat throughout the book those requirements that are pertinent in numerous instances ...
These pharmacopeias have undertaken to not make any unilateral change to this harmonized chapter. 通则<711>溶出度与欧盟药典和日本药典中的相应部分相统一。这三部药典承诺不做单方面的修改。 Portions of the present general chapter text that are nationalUSPtext, and therefore not part of the harmonized...