Guideline

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Q3B(R) Impurities in New Drug Products
Short Title:	Q3B(R)
Internet:	http://www.fda.gov/cder/guidance/7385fnl.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 ICH guideline provides recommendations for the limits and the qualification of impurities to be observed for the marketing authorization of medicinal products containing new active substances.
Status:	Revision 2 July 2006
Document Type:	FDA Guidance for Industry