主题：【求助】usp 621

是需要整篇文章吗？
重新看了一遍文字，应该不需要文章，分类1或3在哪一段里？能帖出来吗？

原文由 yaya91 发表:
是需要整篇文章吗？
重新看了一遍文字，应该不需要文章，分类1或3在哪一段里？能帖出来吗？

DATA ELEMENTS REQUIRED FOR ASSAY VALIDATION
Compendial assay procedures vary from highly exacting analytical determinations to subjective evaluation of attributes.Considering this variety of assays,it is only logical that different test methods require different validation schemes.This chapter covers only the most common categories of assays for which validation data should be required.These categories are as follows.
Category I: Analytical methods for quantitation of major components of bulk drug substances or active ingredients (including preservatives)in finished pharmaceutical products.
Category II: Analytical methods for determination of impurities in bulk drug substances or degradation compounds in finished pharmaceutical products.These methods include quantitative assays and limit tests.
Category III: Analytical methods for determination of performance characteristics (e.g.,dissolution,drug release).
Category IV: Identification tests.
For each assay category,different analytical information is needed.Listed in Table 2are data elements normally required for each of the categories of assays.

还有就是USP附录1225中有说明,但我不清楚像我这种只改变色谱柱,要做哪些验证,是全套还是其中某一个就行

看了，应该属于第三类，例子中有提到的。
有个问题：你上面的这段文字在USP第几页？拜托告诉我一下。谢了！

原文由 yaya91 发表:
看了，应该属于第三类，例子中有提到的。
有个问题：你上面的这段文字在USP第几页？拜托告诉我一下。谢了！

usp附录１２２５　　在２７５１页