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Control of Nitrosamine Impurities in Human Drugs

  1. General Conditions That Lead to Nitrosamine Formation
  2. Sources of Secondary, Tertiary, and Quaternary Amines That Can Form Nitrosamines
  3. Contamination in Vendor-Sourced Raw Materials
  4. Recovered Solvents, Catalysts, and Reagents as Sources of Contamination
  5. Quenching Process as a Source of Nitrosamine Contamination
  6. Lack of Process Optimization and Control
         Nitrosamine         AI Limit (ng/day)
            NDMA                 96
            NDEA                26.5
            NMBA                 96
            NMPA                26.5
            NIPEA                26.5
            NDIPA                26.5