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ICH Q3C(R5) Impurities: Guideline for residual solvents

Short Title:
Q3C(R5)
Origin/Publisher:

ICH Secretariat, c/o IFPMA, 30 rue de St - Jean, P.O. Box 758, 1211 Geneva 13, Switzerland; http://www.ich.org

Document Type:
ICH Guideline
Content:
This guideline describes levels considered to be toxicologically acceptable for some residual solvents in pharmaceuticals. The two guidelines Q3C(M) for n-Methylpyrrolidone and Tetrahydrofuran were unified with the guideline Q3C to the guideline Q3C(R3) in November 2005.

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