| Q3C Impurities: Residual Solvents |
| Short Title: | Q3C |
| Internet: | http://www.fda.gov/cder/guidance/Q3Cfnl.pdf |
| Origin/Publisher: | Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; http://www.fda.gov/cder/guidance/index.htm |
| Content: | This recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutically acceptable limits for residual solvents |
| Document Type: | FDA Guidance for Industry |