USP61/62是什么 USP61/62全称USP 34:2011,General Chapter 61&62,由美国药典委员会(United States Pharmacopeia,USP)制定颁布的。 USP61“非无菌产品的微生物检查:微生物计数试验”。 USP62“非无菌产品的微生物检查:特定微生物试验”。 USP61/62测试目的 检验原材料或成品受微生物污染的情况(非无菌产品微生物限...
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 ...
2月问题: 《美国药典-国家处方集》(USP-NF)中的通用检测方法收录在通则(General Chapter)中,所有的通则都是强制执行的吗? 回答: 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 ...
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...
7. How often do I performthe system suitability test in Total Organic Carbon General Chapter? 根据总有机碳通则,我何时进行系统适用性测试? USP General Chapter <643> intentionallysays nothing about how often the system suitability test (SST) should be run.The reasoning is that this frequency depen...
求助内容： usp 40，General Chapter <659> Packaging and Storage Requirements 谢谢大神！
30 ( 6 ) Stimuli to the Revision Process : Particulate Contaminants of Intravenous Medication and the Limits Set by USP General ChapterNrapendra, NathMcNeal, ElizabethObenhuber, DonaldPillari, BrandaShelton, LisaStevensriley, MarlaSweeney, Neal...
1、USP29-通用章节指导目录(附录)第2页 共7页8通用章节指导Guide to General Chapters目录中此颜色并且带有“ * ”的为新增内容General Requirements for Test and Assays 检查与含量分析的一般要求V 1 INJECTIONS 2455 注射剂V 11 USP REFERENCE STANDARDS 2458 USP 对照品Apparatus for Test and Assays 用于检查...
The USP Parenteral Products-Industrial Expert Committee (PPI EC) has worked during the past three revision cycles to revise USP General Chapter Elastomeric Closures for Injection (381). This Stimuli article summarizes these efforts and in the Appendix provides an overview of the current draft revision...
1、. BACTERIAL ENDOTOXINS TEST USP35 Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopoeia and/or the Japanese Pharmacopoeia. Those portions that are not harmonized are marked with symbols () to specify this fact. 这一章节已经和欧洲药典(EP...