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