ICH Q3C (R6) Residual solvents

Current effective version

PDF iconAdopted guideline

Reference numberEMA/CHMP/ICH/82260/2006
Published01/03/2011
Effective from01/08/2011
KeywordsOrganic solvent, impurity, limits, class, reporting levels, permitted daily exposure (PDE), toxicological
DescriptionThis document recommends acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. It recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. Read together with the annexes on PDF iconspecifications for class 1 and class 2 residual solvents in active substances and residues of solvents used in the manufacture of finished products .

Document history

First version

Current version

PDF iconAdopted guideline

PDF iconAnnexes to guideline

In operation: 01/08/2011–present

Published: 10/02/2005


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