FDA Guidance for Industry: Q3A Impurities in New Drug Substances, Revision 2
Title:
FDA Guidance for Industry: Q3A Impurities in New Drug Substances, Revision 2
Short Title:
Q3A(R)
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/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073385.pdf
Document Type:
Guideline for Industry
Content:
This guideline deals with impurities (organic, inorganic and residual solvents) in new active substances and defines limits as of which impurities must be identified or qualified.