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…