USP 467 for Residual Solvents: Manufacturers Face Challenges with Pharmaceutical Impurities
Wednesday, October 14th, 2009Pharmaceutical manufacturers may face various challenges when attempting to meet the United States Pharmacopeia (USP) requirements for residual solvents (volatile organic chemicals).
Residual solvents in pharmaceuticals are trace level impurities of volatile organic compounds in final products or excipients. In general, residual solvents originate from manufacturing processes related to the preparation of drug products. They can also form during product packaging and storage.