Polybenzimidazole for active pharmaceutical ingredient purification: The Mometasone furoate case study.

Active pharmaceutical ingredient (API) purity is of major concern for pharmaceutical companies and medical community. To reach ultra-low limits of genotoxic impurities (GTIs), imposed by strict legislation, is often time consuming and economically challenging. Therefore, there is a call for efficient unit operations able to remove GTI with minimal API losses from the organic solvent post-reactional streams. This study reports for the first time, a new approach to improve the performance of polybenzimidazole (PBI), a solvent stable polymer, to efficient GTI removal. Two families of GTIs are considered and, the discovery that the use of specific thermal and pH conditioning of PBI adsorbers improves GTI removal efficiency, is reported. Electrospun fibers are explored, aiming at process versatility. Similar removals of GTI, more than 97%, are achieved with virtually no API loss.