Nitrosamine Impurities in Pharmaceuticals: Ensuring Safety and Compliance
Nitrosamine impurities have been a concern within the pharmaceutical industry and by regulatory authorities worldwide since June 2018, when regulators were informed of the presence of N-nitrosodimethylamine (NDMA) in the angiotensin-II receptor blocker (ARB) medicine, valsartan (1).
The most widespread root cause for the occurrence of nitrosamine impurities in drug substances is their unintentional formation during steps of the manufacturing process. Nitrosamine formation observed in API manufacturing can be explained by two general reactions: the oxidation of a hydrazine functional group or by reaction of a vulnerable amine with a nitrosating reagent such as nitrous acid.
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(1) Horne, S., Vera, Matthew D., et. Al. May 2023. Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals. Journal of Pharmaceutical Sciences, Volume 112, Issue 5 P1166-1182.
