[求助] 关于欧洲药典的方法中杂质控制的疑惑 已有2人参与

2楼: Originally posted by 明月的夜 at 2017-08-23 12:52:34
你看下方法的计算方法，看看是怎么计算的。一般用外标法计算。列了那么多杂质，只是告诉你有这些已知杂质。

3楼: Originally posted by zhgjsyzhyang at 2017-08-23 17:29:21
你看看有没有“Other detectable impurities (the following substances would,
if present at a sufficient level, be detected by one or other of
the tests in the monograph. They are limited by the gener ...

4楼: Originally posted by yjjc2012 at 2017-08-23 22:15:25
只有specified impurity才必须控制。后面列出的那些杂质是unspecified,不超过0.10%的话不用鉴定，不超过0.05%的话不用报告

8楼: Originally posted by yjjc2012 at 2017-08-24 12:05:34
建议你学习下ICH Q3a和 Q6，可以解答你的疑问
...