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ICH Q3B(R2) Impurities in New Drug Products

Short Title:
Q3B(R2)
Origin/Publisher:

ICH Secretariat, c/o IFPMA, 30 rue de St - Jean, P.O. Box 758, 1211 Geneva 13, Switzerland

Document Type:
ICH Guideline
Content:
This ICH guideline (draft) provides recommendations for the limits and the qualification of impurities to be observed for the marketing authorization of medicinal products containing new active substances. After its resolution this revised guideline will in future replace the previous Q3B.

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