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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