Nitrosamines in Pharmaceuticals – Is There an End in Sight?

N-nitroso compounds are a family of carcinogens which are formed by the reaction of secondary/tertiary/quaternary amines, alkyl derivatives of amides/ carbamates/urea with nitrite or other nitrogenous agents with the nitrogen in the +3 state.

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“I see—but not by sight alone” – a discussion of FDA’s final guidance, Recommended Acceptable Intake Limits for Nitrosamine Drug […]

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Summary of the FDA, UMD Meeting on June 15, 2023, regarding “Mitigation Strategies for NDSRIs: Quality and BE Considerations” Aloka […]

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