在USP 1469 USP PF Table 4中，规定了亚硝胺杂质分析方法验证项目及可接受标准，如回收率范围是70-130%，在现行版的USP 1469里为何没有了这个要求？实际工作中有没有指导性的文件支持亚硝胺杂质分析方法验证各项目的可接受标准?
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负责该通则的科学联络官是 Dr. Edmond Biba，我把问题转给他，看看他的反馈
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以下是负责该通则的科学联络官的回复
We can direct the stakeholders to the commentary for this and many other questions (adding the link to commentary below).
Here is the answer to this question from the commentary
Comment Summary #100 (three commenters): USP received contradicting recommendations regarding entries in Table 4 and Table 5. One commenter recommended tightening the recommended range for Repeatability and Intermediate Precision and that %RSD of standard solutions at LOQ concentration should be checked for the system suitability test, as the LOQs are associated with acceptance criteria of these nitrosamines. The commenter also recommended adding a statement stating that the methods should have LOQ in the parts-per-billion (ppb) range to meet the low AIs recommended for nitrosamines for consistency with the FDA guidance. A second commenter requested that USP consider a broader range as acceptance criterion for accuracy (70% to 150%).
Response: Comment partially incorporated. The Expert Committee revised the section to remove Tables 4 and 5 and to provide general recommendations regarding performance characteristics that need to be evaluated by the users depending on their specific situation
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非常感谢您的回复，并给我解惑，祝您生活愉快！
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