If for a new chemical entity, the API manufacturer mentions limits for known, unknown and total impurities, can a formulator of that API assign higher limits for the same? If yes, under what guidelines or rules? Thanks 2022-10-02T18:30:00Z
If for a new chemical entity, the API manufacturer mentions limits for known, unknown and total impurities, can a formulator of that API assign higher limits for the same? If yes, under what guidelines or rules? Thanks 2022-10-02T18:30:00Z