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Guideline

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Q3C(R4) Impurities: Guideline for residual solvents
Short Title:Q3C(R4)
Internet:http://private.ich.org/LOB/media/MEDIA5254.pdf
Origin/Publisher:ICH Secretariat, c/o IFPMA, 30 rue de St - Jean, P.O. Box 758, 1211 Geneva 13, Switzerland; http://www.ich.org
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.
Document Type:ICH Guideline