Genotoxic Impurities in Excipients – Not typically a Problem!

David Schoneker , Colorcon, Pennsylvania, USA

  • ICH M7 Guideline for the Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals and IPEC involvement

  • Publication from David Brusick – “A perspective on testing of existing pharmaceutical excipient for genotoxic impurities” (2009)

  • IPEC position and recommendation for the guideline

    • Existing Excipients

    • New or Novel Excipients

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