内容提示: 71 STERILITY TESTS 无菌检查法71 STERILITY TESTS 无菌检查法 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 ...
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建议使用药典中文件标准的名称/标题。 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 “ ...
ThefollowingproceduresareapplicablefordeterminingwhetheraPharmacopeialarticlepurportingtobesterilecomplieswiththerequirementssetforthintheindividualmonographwithrespecttothetestforsterility.PharmacopeialarticlesaretobetestedbytheMembraneFiltrationmethodunderTestforSterilityoftheProducttobeExaminedwherethenatureoftheproductpermits.If...
The initial selection and prioritization of dietary ingredients for admission into the USP-NF compendial monograph development process is based on several considerations, including but not limited to the following:1. Extent of use, based upon market sales or other factors 2. Historical use 3. ...
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:...
是否必须符合USP-NF的描述和溶解性部分所述标准? (See also General Notices, section 5.30. 也参见通则5.30) 5.30. Description and Solubility 描述和溶解度 Only where a quantitative solubility test is given in a monograph and isdesignated as such is it a test...
除非另有说明,纯化水也可被用于所有的检查实验与含量分析(在指明用水的时候)(见凡例)纯化水在整个USP-NF中被提及,regardless of the font and letter case used in its spelling ,water complying with the Purified Water monograph is intended.纯化水必须符合离子的和有机的化学纯度的要求,而且必须能够预防微...