Analytical Method Challenges for EP Monograph, Captisol ®
At the 2023 American Drug Delivery and Formulation Summit, Ryan Memmer from Singota Solutions (leading CDMO in Bloomington, Indiana), captivated the audience with his insightful presentation on “Analytical Method Challenges for EP Monograph,” titled “Captisol®: What gives European Pharmacopeia?!” Memmer’s expertise in small batch aseptic filler and aseptic manufacturing solutions was evident as he delved into the intricacies of injectable formulation development. His discussion extended beyond formulation challenges to encompass the crucial aspects of cold chain pharmaceutical storage and the necessity of maintaining a GMP compliant warehouse. Through Memmer’s presentation, attendees gained valuable insights into navigating the complexities of analytical methods, particularly in the context of EP Monograph standards, shedding light on the critical role of Captisol® in pharmaceutical formulations within the European Pharmacopeia framework.
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