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Control of Nitrosamine Impurities in Human Drugs

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  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