Also, according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described inUSP–NFare not required to validate the accuracy and reliability of these methods, but merely verify their suitability under actual conditions of use. Recognizing the legal status ofUSPandNF...
USP905含量均匀度中英文准备足够数量的剂量单位的复合样本来提供给各论中含量测定以及各论中含量均匀度测定测试法项下特殊的数量要求用这些测试法需要将片剂磨成粉末或是将单个包装的胶囊口服液体制剂混悬剂乳剂凝胶剂或固体制剂中内容物混合得到均一的混合物 <905>UNIFORMITY OF DOSAGE UNITS ContentUniformity The ...
非无菌产品微生物学检查：微生物计数检查法USP61中英对照版 <61> MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMENRATION TESTS 非无菌产品微生物学检查：微生物计数检查法 INTRODUCTION 导言 The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi that ...
General recommendations are given with theunderstanding that modifications of the apparatus and procedures as given inUSPgeneral chapters need to be justified. <1092>章节讨论了溶出度实验的开发和验证,重点是口服固体制剂。所提出的许多概念也可能适用于其他剂型和给药途径。关于设备和方法的修改部分在USP通则中...