Contemporary Opportunities and Challenges in Characterizing Crystallinity in Amorphous Solid Dispersions

27 September 2022 11:40 - 12:15

The first half of this presentation highlights the unique challenges of analytical methodologies to monitor crystalline drug substance in ASDs and their associated drug products. Challenges around use of limit tests, analyte spiking experiments, and method robustness are also underscored. The latter half describes the merits and limitations of the diverse analytical "toolbox" (such as XRPD, NIR and DSC), which can be readily applied during development and, in some cases, considered for potential application and validation in the commercial QC setting when necessary.