About this document
Purge Factor Calculation for GTIs by swamyg4444 is a document available to read on EtoBox.
The document discusses strategies for assessing and controlling genotoxic impurities (GTIs) in new chemical entities, outlining four options for routine testing and control based on acceptable limits. It emphasizes the importance of a scientific risk assessment to justify the absence of impurities, particularly through the determination of a purge factor that quantifies the elimination of GTIs during the synthesis process. Case studies illustrate the application of these strategies, highlighting the need fo
- Author
- swamyg4444
- Language
- EN