ICH Q3C (R6) Residual solvents

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/ICH/82260/2006
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 specifications 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

Adopted guideline


Annexes to guideline

In operation: 01/08/2011–present


Published: 10/02/2005


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