N-nitroso-amlodipine ; N-nitroso-felodipine ; synthesis not successfull but still listed by FDA and EMA as NDSRIs

In the case of NDSRIs, evidence can also be generated experimentally… by a simple NAP test or in a more standardized approach, as Ashworth et all. proposed in their recent publication “Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs)”

Enhance NAP Test →

Standarizations of Nitrosation conditions →

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