The formation of nitrosamines as well as other mutagenic impurities in drug substances and drug products may compromise their safety, quality, and clinical outcomes. Estimating impurity profiles, as well as controlling and monitoring them, has become an unavoidable aspect of the comprehensive development and production of novel medicines. The proactive detection of genotoxic impurities should be implemented at every step of drug development to comply with growing regulatory standards and avoid costly recalls.
- nitrosamine impurity risk assessment to optimize timeframes and costs
- reducing nitrosamine contamination from raw materials to finished drugs
- appropriate analytical instruments for detecting nitrosamine impurities
- practical and compliant implementation of ICH M7 and ICH Q3D guidance
- impurity profiling in drug substances, intermediates, and drug products
- E&L as an impurity source – removing the risks associated with E&L