USP性状，pH，装量，可见异物，不溶性微粒需要做方法验证或确认吗？

feifei931121

大家好！
我们有一个产品正在申报国外注册，客户反馈回来问我们该品种（USP标准）为什么不做性状，pH，装量，可见异物，不溶性微粒的验证，
我知道中国药典分析方法验证指导原则中专门有类似的描述：
确认豁免：如果没有特别说明，药典收载的的通用检测方法无需确认，这些通用检测方法包括但不仅限于干燥失重、炽灼残渣、多种化学湿法和简单的仪器测试（如pH测定法）。

请问大家知道USP，ICH中有这些类似的内容吗？或者其他法规，或者是大家有没有遇到过这类的问题，又是怎样回复的呢

非常感谢！

Shinichi00

USP<1226> VERIFICATION OF COMPENDIAL PROCEDURES

Verification is not required for basic compendial test procedures that are routinely performed unless there is an indication that thecompendial procedure is not appropriate for the article under test. Examples of basic compendial procedures include, but are notlimited to, loss on drying, residue on ignition, various wet chemical procedures such as acid value, and simple instrumentaldeterminations such as pH measurements. However, for the application of already established routine procedures to compendialarticles tested for the first time, it is recommended that consideration be given to any new or different sample handling or solutionpreparation requirements.
希望对你有帮助

feifei931121

Shinichi00 发表于 2021-5-7 14:10
USP VERIFICATION OF COMPENDIAL PROCEDURES

Verification is not required for basic compendial test  ...

非常有帮助 多谢您！