Nitrosamine

Nitrosamine Risk Assessment in Pharmaceuticals

Nitrosamine Risk Assessment in Pharmaceuticals

Nitrosamines are potential carcinogens that can form in drug products through different pathways. Regulatory authorities such as the USFDA, EMA, and WHO mandate a thorough risk assessment to identify, mitigate, and control nitrosamine impurities in products. Key Steps in Nitrosamine Risk Assessment: Identify Potential Risk Factors: Evaluate Potential Pathways of Formation: Perform Analytical Testing: Risk…