Draft Guidance for Industry on Residual Solvents in Drug Products Marketed in the United States; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Control of Residual Solvents in Drug Products Marketed in the United States." On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter "Residual Solvents," which replaced USP General Chapter "Organic Volatile Impurities." The change affects all compendial drug products marketed in the United States. This draft guidance reflects FDA's recommendations on how to comply with those USP changes.