The importance of polymorphism and solvation phenomena for pharmaceutical products is so significant that the discovery of API polymorphism should not be left, at this stage of scientific advance, to serendipity or happenstance. Comprehensive polymorphism studies are IP enabling and also crucial for NDA filling. Through our polymorph screening services, we investigate isolation and crystallization of the API in a number of solvents with different properties and under a variety of conditions to identify and characterize new solid forms (polymorph, hydrate, solvate) and to understand the relationship between them. Our routine polymorph screening employs several crystallization techniques including:
- Anti-solvent addition
Our flexible screening designs can be tailored to the Client’s needs based on which phase of the development they are focused on and what are their concerns and limitations. Utilizing High-Throughput Screening (HTS) technologies, our routine screening requires minimum amount of API while performing a large number of crystallization experiments (384 experiments per run) resulting a significant reduction in cost.
Related instruments: Unchained Labs Junior™, Bruker D8 Discover™