USP General Tests & Assays 中英对照 USP General Tests & Assays 目录中文翻译 General Requirements for Tests and Assays 检查与含量分析的一般要求 1<1>INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS注射和植入药物产品(非肠道)-产品质量检测 2<2>Oral Drug Products-Product ...
<61>MICROBIAL LIMIT TESTS……2503微生物限度检查法 <71>STERILITY TESTS……2508无菌检查法 Biological tests and assays生物检查法与测定法 <81>ANTIBIOTICS—MICROBIAL ASSAYS……2513抗生素-微生物测定 <85>BACTERIAL ENDOTOXINS TEST……2521细菌内毒素检查法 <87>BIOLOGICAL REACTIVITY TESTS, IN VITRO……2525体外...
24 EST 2017 USP 40 General Requirements / á1ñ Injections and Implanted Drug Products 67 General Chapters General Tests and Assays General Requirements for Tests and Assays á1ñ INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS)—PRODUCT QUALITY TESTS G e n e r a Change to read: l C ...
chapter is assigned a number that appears in brackets adjacent to the chapter name e g Chromatography Articles recognized in these compendia must comply with the official standards and tests and assays in the General Notices relevant monographs and General Chapters numbered below 1000 General Chapters ...
《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 Official te...
E617, “Laboratory Weights and Precision Mass Standards.” This standard is incorporated by reference and should be consulted for full descriptions and information on the tolerances and construction of weights.1 Pharmacopeial tests and assays require balances that vary in capacity, sensitivity, and ...
Tests and Assays 一般检查法与测定法2021MICROBIAL ENUMERATION TESTSNUTRITIONAL AND DIETARY SUPPLEMENTS3080微生物数量实验营养与食品添加剂2022MICROBIOLOGICAL PROCEDURES FOR ABSENCE OF SPECIFIED MICROORGANISMSNUTRITIONAL AND DIETARY SUPPLEMENTS3083不得检出特定微生物的程序营养与营养补充剂2023MICROBIOLOGICAL ATTRIBUTES OF ...
优·USP 通用章节目录.doc,Guide to General Chapters 通用章节指导 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 <1>INJECTIONS……2455 注射剂 <11>USP REFERENCE STANDARDS……2458 USP对照品 App
USP中涉及药包材的相关章节分布于通用章节(general chapters)中, 其中又分为通用检查与测定法(general tests & assays)和通用信息(general information)章节。通用检查与测定法章节一般属于强制执行的内容(除非另有规定), 包括了对药包材的通用要求, 以及塑料...
＜71＞STERILITY TESTS……2508 无菌检查法 Biological tests and assays 生物检查法与测定法 ＜81＞ANTIBIOTICS—MICROBIAL ASSAYS……2513 抗生素－微生物测定 ＜85＞BACTERIAL ENDOTOXINS TEST……2521 细菌内毒素检查法 ＜87＞BIOLOGICAL REACTIVITY TESTS, IN VITRO……2525 体外的生物反应性检查法 ＜88＞...