A Review on Synthesis and Biological Activities of Nitrosamine Impurities in Active Pharmaceutical Ingredients (APIs)

Nitrosamine impurities are chemical compounds that can unintentionally form in active pharmaceutical ingredient during manufacturing or storage. Nitrosamine are carcinogenic and genotoxic. Nitrosamines are a group of nitroso compounds that can be formed when secondary or tertiary amine from API like-Lansoprazole, Dasatinib, Nilotinib or Oxybutynin react with nitrosating agents like NaNO2 in acidic medium or Tert-butyl nitrite etc. Validated analytical methods are used for identification and quantification these impurities. Highly sensitive instruments like High performance liquid chromatography (HPLC) and Gas chromatography (GC) required for quantification of these impurities and Mass Spectroscopy (MS) and Nuclear Magnetic Resonance (NMR) are required for identification, these impurities have certain limit which can be detected on these instruments.

Nitrosamine impurities, Drug substances, Classifications, Drug product, Impurities, Impurity synthesis

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