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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

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.

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