The following procedures are applicable for determining whether a Pharmacopeial article purporting to be sterile complies with the requirements set forth in the individual monograph with respect to the test for sterility. Pharmacopeial articles are to be tested by theMembrane Filtrationmethod underTest for...
ThefollowingproceduresareapplicablefordeterminingwhetheraPharmacopeialarticlepurportingtobesterilecomplieswiththerequirementssetforthintheindividualmonographwithrespecttothetestforsterility.PharmacopeialarticlesaretobetestedbytheMembraneFiltrationmethodunderTestforSterilityoftheProducttobeExaminedwherethenatureoftheproductpermits.If...
usp: drug substances and products, including combinations nf: excipients dietary supplements: botanicals, vitamins and minerals 范畴:范畴: usp:原料药和制剂,包括复方 制剂 nf: 辅料 dietary supplements: 植物药、 维生素和矿物质 21 monographs monograph components (in alphabetical order) molecular formula ...
USP: Drug substances and products, including combinations NF: Excipients Dietary Supplements: Botanicals, vitamins and minerals 范畴: USP:原料药和制剂,包括复方制剂 NF: 辅料 Dietary Supplements: 植物药、维生素和矿物质 Monographs Monograph components (in alphabetical order) ? Molecular Formula ?
例如“USP Losartan Potassium Monograph”,不做其他进一步的说明。这样的“一般性引用”被理解为是指该标准的现行生效版本。 关于这个引用方式,在药典中有明确说明吗? 有的。 在凡例:1. “TITLE AND REVISION”有说明:“Where the terms “ USP ,”“ NF ,” or “ USP-N F” are used without further qu...
Background The purpose of this Guideline is to set forth the criteria that USP Expert Committee uses to determine whether or not a dietary ingredient qualifies for admission to the process for the development of a quality monograph. The Guideline establishes a Class A and Class B system ...
Unlessotherwisedirectedinthemonograph,systemsuitabilityparametersared eterminedfromtheanalytepeak. 除非各论中另有规定,系统适用性参数以分析物的峰来测定。 Relativeretentiontimesmaybeprovidedinmonographsforinformationalpurpos esonly, orelativeretentiontimes. 相对保留时间可以在各论中提供,仅仅作为相关信息,以帮助峰的...
从2OOO年USP24-NF19开始,美国药典委员会 在发行其印刷版的同时,还发行光盘版. 2lISP27-NF22的内容简介 2.1USP27 USP27内容包括前言(FrontMatter),凡例(GeneralNo— rices),USP正文(USPMonograph),通则(GeneralChapters),试剂 (Reagents),参考图表(ReferenceTables),食品补充剂(Dietary Supplements)等. 作者简介:...