The FDA Agency has released a final guidance document that is aimed at drug manufacturers and applicants, offering a framework for assessing the mutagenic and carcinogenic potential of NDSRIs in drug products. NDSRIs are nitrosamine impurities structurally similar to APIs and often lack specific safety data.
The guidance proposes a methodology for determining acceptable intake limits based on structural characteristics of NDSRIs, helping manufacturers and applicants assess impurities in their drug products.
The FDA also plans to provide updated information on recommended AI limits, testing methods, and safety assessments for NDSRIs to address the evolving and technical aspects of this issue. This guidance is crucial for ensuring the safety of drug products and compliance with FDA regulations.
To learn more about harnessing the latest FDA guidance on Nitrosamine Drug Substance-Related Impurities (NDSRIs), talk to our in silico experts at InSilicoMinds today!
