In eu pharmacopeia-------if disregard limit for related substances is 0.1%, then?


For a certain API, If disregard limit for related substances is 0.1%!!!
Then what would be the identification threshold and qualification threshold for a single unspecified impurity???
In this context, if content of an unspecified impurity is larger than 0.1%, should I simply report it or have to identify it???

0.1% reporting limit seems quite high. What is the API?
In this case you may have to identify any unknown impurity above reporting limit.

Hi, thanks for your reply.
In the new supplement, an impurity item “unspecified impurities” is incorporated, its limit is not larger than 0.4%.
Reporting threshold is still 0.10%, the general monograph 2034 doesn’t apply to this individual monograph.

I have another question, to the “unspecified impurities” on Certificate of Analysis, should I report only the largest unspecified impurity or all unspecified impurities that larger than 0.10%? How do you deal with this matter in your company?