Invited
Facing process related impurities before they strike

Manufacturing process of a drug substance (Active Pharmaceutical Ingredient, API) doesn’t just comprise a sequence of chemical transformations targeted to the desired compound, but it is accompanied by a variety of undesired chemical reactions that result in impurities. Detection of new impurities may surprise process chemists and engineers upon scale up or even after running the process smoothly in commercial scale for a while, thus causing extensive troubleshooting work on the manufacturing process already filed (with health authorities).

This talk will be devoted to rather basic chemistry considerations that might be useful to foresee and avoid/suppress formation of impurities as well as to better control chemical and physical quality of final API.