章节测定法usp目录assay通用 GuidetoGeneralChapters通用章节指导 目录中此颜色并且带有“***”的为新增内容。 GeneralRequirementsforTestandAssays 检查与含量分析的一般要求 <1>INJECTIONS……2455 注射剂 <11>USPREFERENCESTANDARDS……2458 USP对照品 ApparatusforTestandAssays 用于检查与含量分析的器具 <16>AUTOMATEDMETH...
They contain no mandatory requirements applicable to any official article unless specifically referenced in General Notices, a monograph, or a general chapter numbered below 1000. General chapters numbered above 2000 apply only to articles that are intended for ...
Chapter, Official April 1,2006).2671崩解时限(协调的章节,法定日期,2006.4.1)711DISSOLUTION2673 溶出度*711Dissolution (Harmonized Chapter, Official April 1,2006).2675 溶出度(协调的章节,法定日期,2006.4.1)721DISTILLING RANGE2682馏程724DRUG RELEASE2682药物释放度*724Drug releasee (Harmonized Chapter, ...
<351>ASSAYFORSTEROIDS……2565类固醇(甾类化合物)测定法 <361BARBITURATEASSAY……2565巴比妥类药物测定法 <371>COBALAMINRADIOTRACERASSAY……2566钴铵素放射性跟踪剂测定法 <381>ELASTOMERICCLOSURESFORINJECTIONS……2567注射剂的弹性密封件 <391>EPINEPHRINEASSAY……2567肾上腺测定法 ...
USP41砝码与天平 USP36- <41>砝码与天平 <41>BALANCES砝码与天平（译文）Change to read:This chapter states the requirements for balances used for materials that must be accurately weighed (see General Notices, 8.20). Unless otherwise specified, when substances must be “accurately weighed”, the ...
1、BRIEFING<1224Transfer of Analytical Procedures.分析方法转移After publication of the Stimuli article Transfer of Analytical Procedures: A Proposal for a New General Information Chapter" in PF 35(5) Sept.-Oct. 2009 and based on comments received, the General ChaptersPhysical Analysis Expert Committe...
2778 制剂单位的含量均匀度<905>UNIFORMITY OF DOSAGE UNITS (Harmonized Chapter, Official April 1,2006)……2780 制剂单位的含量均匀度(协调的章节2006.4.1)<911>VISCOSITY……2785 粘度<921>WATER DETERMINATION……2785 水测定法<941>X-RAY DIFFRACTION……2788 X光衍射 General Information 通用信息<1010>...
认识到USP和NF标准的法律地位，因此，提议采纳新的或更改过的药典分析规程时，以充分的实验室数据作为支持，以记录其有效性，成为基本要求。The text of this information chapter harmonizes, to the extent possible, with the Tripartite International Conference on Harmonization (ICH) documents Validation of ...
I ndividual USP or NF monographs as well as certain General Chapters specify the USP Reference Standard(s) required for assay and test procedures. General Chapter <11> USP Reference Standards provides general informa-tion and instructions for proper use and storage. Consult the label text for...
Pharmacopeial tests and assays require balances that vary in capacity, sensitivity,and reproducibility.Unless otherwise specified,when substances are to be“accurately weighed”for Assay,the weighing is to be performed with a weighing device whose measurement uncertainty(random plus systematic error)does ...