Hi @Filip, Welcome to our Nitrosamine Exchange community. You bring a very vivid question. Under which circumstances is AMES test accepted to derisk a Nitrosamine Impurity?
As @conudel share in his recent webinar ( Calculating Nitrosamine Limits (MasterClass) ), there is still a lot of uncertainty about the acceptance or not of AMES test data among regulatory agencies. The good news is the recent development from EMA where AZIDO impurities were classified as ICH M7 class 5 after investigation.