Impurities

Nitrosamine Risk Assessment in Pharmaceuticals

Nitrosamine Risk Assessment in Pharmaceuticals

Byipharmacist

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…

ICH Guidelines on Impurities | A Simplified Breakdown

ICH Guidelines on Impurities | A Simplified Breakdown

Byipharmacist

Navigating through the complexities of ICH guidelines can be daunting for pharmaceutical professionals. Here’s a distilled comparison to clarify how these standards apply across different stages of drug development:   ICH Q3A & Q3B: Focus on organic and degradation impurities in new drug substances and products, emphasizing safe limits and identification protocols.   ICH Q3C:…