Exploiting Solvent and Impurity Effects to Modify Crystal Shape and Bulk Powder Properties of API and Intermediate Molecules

Crystallization design is mainly focused on designing API manufacturing process to deliver drug molecules with desired particles size and shape, as well as bulk powder properties to allow downstream formulation process to be more robust and less expensive. However, similar focus on upstream steps of the API process could benefit from improved physical properties of the API or intermediates that lead to better filtration, impurity rejection, cycle time, and throughput on scale. This work will present examples showcasing merits of exploiting solvent and impurity effect to improve process robustness and productivity.