Separation of Pharmaceutical Process-Related Impurities via an Organic Solvent Nanofiltration Membrane Cascade

The control of impurities is a critical issue in pharmaceutical industry and very strict regulations related with this issue have been introduced by ICH (International Conference on Harmonisation). The drugs impurities in general are classified into two types: (1) impurities associated with the Active Pharmaceutical Ingredients (API) production and, (2) impurities generated during formulation and or with aging or that are related to the formulated forms. According to ICH guidelines, impurities associated with API are either organic, inorganic ones or residual solvents. Organic impurities include unreacted starting materials, intermediates, byproducts, degradation products, reagents, ligands, and catalysts. The undesirable chemicals that remain with the APIs during manufacturing so called process-related impurities, could be generated at any of the synthetic steps in variant solvents.