Assessment of incompatibilities between API and excipients is a critical part of formulation development. Along with chemical instability considerations, changes to the physical form of API in any unit operation of drug product processing can significantly impact the quality and performance of the formulation. In order to understand and identify the origin of physical form changes, it is first critical to have the appropriate tools to measure these form changes.
At Crystal Pharmatech, we have the techniques and experience to choose the fastest, most accurate methods for monitoring and identifying the origin of physical form changes. This includes XRPD, Raman microscopy, DSC, and a full array of solid-state NMR relaxation and multidimensional techniques. We strive to apply the right technique to the specific concern at hand and to not over engineer a solution to your problem. We realize every problem is not a nail, however, we have the golden hammers when needed.