3.What is the difference between the new reference standard (USP Dissolution Performance Verification Standard – Prednisone RS catalog #1222818) and the current reference standard (USP Prednisone Tablets RS catalog #1559505)? 新的标准物质(USP溶出度性能验证标准--泼尼松片RS(产品编号1222818))与现行标...
as well as the necessity and appropriate frequency of anybatch testing, are neither specified nor prescribed by the compendia; whetherand when to test is left to the preferences or direction of those performingcompliance testing, and other users of USP–NF...
美国药典凡例中英文 USP32 NF27 General Notice
Furthermore, section 6.50.20.1states that "When a specified concentration is called for in a procedure, a solution of other normality or molarity may be used, provided that allowance is made for the difference in concentration and that the change does not increase the error of measurement." 问...
Frequency of testing and sampling are left to the preferences or 取样的频率取决于执行符合性检测的要求以及使用 direction of those performing compliance testing, and other users of USP–NF, including USP-NF 的用户,包括生产商、消费者和监管机构。 manufacturers, buyers, or regulatory authorities. (...
Accuracy is calculated as the percentage of recovery by the assay of the known added amount of analyte in the sample, or as the difference between the mean and the accepted true value, together with confidence intervals.The ICH documents re 37、commend that accuracy should be assessed using a...
according to these regulations [21 CFR 211.194(a)(2)], users of analytical methods described in USP-NF are 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 of USP and NF st...
and must appear in block capital letters 标明与药典标准的符合性 当在某个物品的标签上使用 USP 或 NF 等字 母以显示与药典标准的合规性时 这些字母与该物品的药典名称一起出现 或 在适当时 与其中装有的组分一起出现 这些字符不得以诸如圆字 方字之类 的符号出现 而必须为印刷体大写字母 If a dietary...
Variation in dissolution results between the two vessels recommended in USP XVIII and NF XIII prompted an investigation of vessel shape and its effect on dissolution. Further testing was carried out with a dissolution vessel whose concavity was obviously different from those recommended but still ...
美国药典凡例中英文 USP NF General Notice