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ICH Q3A(R2) Impurities in New Drug Substances

Short Title:

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

Document Type:
ICH Guideline
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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