ICH Q3A(R2) Impurities in New Drug Substances

Title:
ICH Q3A(R2) Impurities in New Drug Substances
Short Title:
Q3A(R2)

https://www.gmp-compliance.org/files/guidemgr/ICH Q3A R2.pdf

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 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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