Controlling Polymorphic Impurities in Pharmaceutical Processes

In this webinar, guest speaker Jude Eames from Eurofins CDMO Alphora will share a case study on polymorphic impurities in pharmaceutical process development. The case study highlights the importance of understanding polymorphic transitions to isolate a less thermodynamically stable polymorph. It highlights how the Crystal16 and Crystalline were utilized to diagnose problems in the process. Polymorphic impurities can be especially problematic: often undetectable in early stages. They may only surface later in development. This leads to process redesign and costly delays.