ICH M7 control option 4: How to confidently demonstrate control of mutagenic impurities in API synthesis (without analytical testing)
If you’re currently relying solely on analytical testing to check for mutagenic impurities in your active pharmaceutical ingredient (API), there is a more time- and cost-effective option available that doesn’t compromise patient safety. Recent data for a medium-sized pharmaceutical company showed that you could save $1.35M annually and reduce time taken by 77%, using in […]