USP通则41“天平”具有强制性,对必须用于准确称量的天平提出了要求。应使用在整个称量范围内都经过校准,并且满足重复性和准确度要求的天平进行称量。 USP通则1251“在用于分析的天平上称量”是适用于在所有分析过程中所使用天平的指南。它提供了关于安装与操作认证(IQ/OQ)、性能认证与天平检查(日常测试)、最小称量值...
USP 通用章目录.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 Apparatus
For discussion of the theoretical basis of these requirements, see general information chapter Weighing on an Analytical Balance 1251 , which may be a helpful—but not mandatory—resource. 关于这些要求的理论基础的讨论,参见凡例<1251采用分析天平称量>,可能会有帮助---但不是必须。 REPEATABILITY重复性 Re...
<1251> WEIGHING ON AN ANALYTICAL BALANCE 翻译人：Julia 使用分析天平称量 （本文件来自USP37-NF32，...
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1 Guide to General Chapters 通用章节指导 ... 2 <21> 温度计(译文) ... 13 <31> 容量器具 ... 14 <41> 砝码与天平(译文) ... 16 <61> 微生物限度检查 ... 18 231 HEAVY METALS 重金属 ..
USP29-通用章节指导目录(附录) 第8页 共7页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1INJECTIONS2455注射剂11USP REFERENCE STANDARDS2458USP对照品Apparatus for Test and Assays用于检查与含量分析的器具16...
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1、USP38-通用章节指导目录(附录) Guide to General Chapters 通用章节指导 General Requirements for Test and Assays 检查与含量分析的 股要求 V 1 INJECTIONS AND IMPLANTED DRUG PRODUCTS (PARENTERALS) PRODUCT QUALITY TESTS注射和植入药物产品(注射用)一产品质量测试 V 1 INJECTIONS 注射剂 V 2 ORAL DRUG ...
What are the important facts in USP General Chapters 41 and 1251? Chapter 41 states that accurate weighing must be performed using a calibrated balance. A more demanding balance assessment is introduced. Repeatability and accuracy tests are defined with acceptance limits and permissible test weights...