The pharma industry has lately been affected by rising regulatory concerns around Class 1 solvent contamination in drug products; recent product recalls in addition to issued regulatory guidance documents and the removal of select pharmacopeia monographs demonstrate this. Though much of the attention has been focused on benzene contamination, cumulatively, this is part of a potential trend of regulations moving towards discouraging the presence of other Class 1 solvents in drug products and excipients. And when there is possibility for changing regulations, developers may be pondering the best way to “future-proof” their formulations to ensure speed to market.
In this webinar, the Lubrizol Pharmaceutical team discusses the recent regulatory trends pertaining to Class 1 solvents, as well as how to prevent being affected by any potential changes in the future by using high quality, well-tested excipients. Lubrizol also reviews case study data analyzing competitive excipient materials for residual Class 1 solvent levels.
Webinar #1 in this series, "Reformulating Drug Products Containing Carbomers with Benzene", can be viewed here.