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FDA Guidance for Industry: Q3B(R) Impurities in New Drug Products

Short Title:

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 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.

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