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FDA Guidance for Industry: Q3C Impurities: Residual Solvents
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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm ; http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073394.pdf
Document Type:
FDA Guidance for Industry
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
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