In this webinar we introduce Leachables stability studies and will cover impurities, method and stability requirements.
Leachables are impurities that originate from drug contact surfaces (typically the final container/closure system). Leachables stability studies are generally less understood than those conducted for typical drug-related impurities, and performing them can be challenging. ICH stability requirements are not directly applicable to leachables. This presentation will cover the definition of leachables and where they come from, the similarities and differences to drug product-related impurities, and method and stability requirements.
Bringing together some of the brightest minds in both the public and private sectors, the ‘Science of Drug Development’ webinar series is a joint effort between EAG Laboratories and the University of Wisconsin. A public/private educational venture, the series aims to help organizations eliminate obstacles that stand in the way of bringing the next generation of pharmaceuticals to market.
In this webinar we will cover:
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