New strategy for N-nitrosamine impurities in Ph. Eur. monographs
The EPC agreed to delete the Production section covering N -nitrosamine impurities from existing individual monographs on active substances and to avoid including such statements in new monographs in the future. In addition, the EPC defined clear rules on when a specification for N -nitrosamine impurities should be added to the Tests section of an active substance monograph. Such a specification will therefore only be included when the N -nitrosamine is a process-related impurity, i.e. generated during synthesis of the substance, or a degradation impurity arising from its storage.
In view of this new strategy, revised versions of the five individual sartan monographs (Valsartan, Irbesartan, Candesartan cilexetil, Olmesartan medoxomil and Losartan potassium ), from which the Production section referring to N -nitrosamines had been deleted, were submitted to and adopted by the EPC at the same session.