The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA Guidance for Industry: Q3C Impurities: Residual Solvents


Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Food and Drug Administration; 5600 Fishers Lane; Rockville, MD 20857; ;

Document Type:
FDA Guidance for Industry
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

Go back

GMP Conferences by Topics