药品分析方法验证要点的讨论

分析方法验证是一个和分析方法建立相联系的过程，用于证明建立的方法及其参数满足分析应用要求。本文以《中华人民共和国药典》2015年版四部通则（9101）的验证内容为主线，对方法学验证中的一些要点进行了讨论。

Validation of an analytical method is the process related to the establishment of analytical method, which is used to demonstrate the established method and typical performance characteristics to meet the requirements of the intended analytical applications.The main points about the validation of the analytical method as required in appendix (9101)of Chinese Pharmacopeia 2015 edition are discussed in this paper.

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