Organic solvent nanofiltration: A platform for removal of genotoxins from active pharmaceutical ingredients

► Genotoxics impurities (GTI) are often present in pharmaceutical ingredients (API). ► Organic solvent nanofiltration (OSN) is proved to remove GTIs from APIs. ► Eleven GTIs and nine APIs of industrial interest are used as model compounds. ► Different case studies, using two OSN membranes in diafiltration mode are presented. ► Guidelines for assessment API/GTI separation feasibility are discussed.