USP 程序中使用的定性和定量分析中可以使用的色谱法类型是柱 气相 薄层 包括高效薄层色谱法 加压液相色谱法 通常称为高压或高效液相色谱 法 由于方便 简单 纸和薄层色谱法通常在鉴别用途中更加有效 柱色谱 法对固定相提供了更广泛的选择 并且可用于从混合物中大量分离单个化合物 现代高效薄层色谱法 气相色谱法 加压...
美国药典USP31-NF26无菌检查法《71》.doc 71 STERILITY TESTS无菌检查法 Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. Those portions that are not harmonized are marked with symbols () to specify this ...
美国药典USP31-NF26色谱《621》621 CHROMATOGRAPHY色谱法 INTRODUCTION介绍 This chapter defines the terms and procedures used in chromatography and provides general information. Specific requirements for chromatographic procedures for drug substances and dosage forms, including adsorbent and developing solvents, ...
美国药典USP31-NF26无菌检查法《71》.doc,71 STERILITY TESTS 无菌检查法 The following procedures are applicable for determining whether a Pharmacopeial article purporting to be sterile complies with the requirements set forth in the individual monograph wit
资源描述 1、71 STERILITY TESTS 无菌检查法 The following procedures are applicable for determining whether a Pharmacopeial article purporting to be sterile complies with the requirements set forth in the individual monograph with respect to the test for sterility. Pharmacopeial articles are to be tested...
美国药USP31-NF26药典规程的验证《1225》和药典规程的确认《1226》 热度: 美国药典USP31-NF26色谱《621》 热度: 相关推荐 71STERILITYTESTS无菌检查法 ThefollowingproceduresareapplicablefordeterminingwhetheraPharmacopeialarticle purportingtobesterilecomplieswiththerequirementssetforthintheindividualmonograph withrespe...
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 ...
《美国药典》(USP31/NF26)附录非无菌产品的微生物检查-控制菌检查法,《美国药典》(USP31/NF26)附录非无菌产品的微生物检查-控制菌检查法,usp 美国药典,usp美国药典最新版,美国药典usp35,美国药典usp35下载,美国药典usp下载,usp美国药典中文版,美国药典 usp37,美国药典usp32,美国药典 usp38,...
通则药典规程的验证<1225>提供了关于不同测试种类应当考虑的特性,以及应当伴随为成为法定程序而递交给USP-NF的申请文件中的记录文件的相关信息。确认包括评估选定的分析工作特性,例如那些在通则<1225>中描述的,以生成适合、相关的数据,而不是重复验证程序。 Users of compendial analytical procedures are not required ...
美国药典USP31-NF26无菌检查法《71》71STERILITYTESTS无菌检查法ThefollowingproceduresareapplicablefordeterminingwhetheraPharmacopeialarticlepurportingtobesterilecomplieswiththerequirementssetforth in the indi vidual monogr aph wit h respect to the test for sterilit各稚脚检装尘颂鸡冕犊朴刽辜彩瘫此于譬催暮唆...