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Pathways for N-nitroso compound formation: secondary amines and beyond

López-Rodríguez R; McManus J; Hill (Murphy) NS; Ott MA; Burns MJ;

Publication abstract

Recent drug recalls (e.g. Valsartan, Ranitidine) linked to the discovery of nitrosamine impurities have led to increased regulatory scrutiny in the manufacturing process of marketed medicines, notably, determining any sources of risk for nitrosamine (or related N-nitroso compound) formation within the manufacturing process. This review seeks to aid the risk assessment process through identifying known conditions and reactants through which N-nitroso compounds can be formed.

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