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
<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...
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 ...
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 ...
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...
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, 以及塑料材料及包装系统、弹性体密封件、玻璃容器和辅助组件的产品标准...
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 ...
《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...
1151ñ. [N OTE —All references to chapters above 1000 are for informa-tional purposes only, for use as a helpful resource. These chapters are not mandatory unless explicitly called out for applica-tion.]This chapter is divided into three main sections: (1) universal product quality tests ...