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

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

HEEEEEEEEELP!!!

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???

2

[quote=langkawi]HEEEEEEEEELP!!!
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.

3

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?