Mutagenic Impurity poster now available
The poster presented on the 10th of October in London at the Mutagenic Impurities workshop organized by the Joint Pharmaceutical Analysis Group is now available.
If you have any questions please do not hesitate to contact us, we'll be pleased to discuss with you the results of the poster or how to apply the same approach in your company.
The ICH M7 guideline provides a framework for assessing and controlling DNA reactive impurities in a pharmaceutical product. When no adequate experimental mutagenicity and/or carcinogenicity results are available, an assessment of Structure-Activity Relationships (SAR) that focuses on bacterial mutagenicity predictions should be performed. Currently genotoxic impurities are identified periodically using an expert panel. This creates a time delay between impurity elucidation and assessment. If potential genotoxicity can be identified during or shortly after elucidation, projects can be run more efficiently and the number of compounds needing expert assessment can be significantly reduced. This poster describes an early screening workflow for genotoxicity that can be applied to alert process and analytical chemists much earlier than is currently possible