ICH Q3C (R7) Residual solvents

KeywordsOrganic solvent, impurity, limits, class, reporting levels, permitted daily exposure (PDE), toxicological

This 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 .

Please note that the document has been corrected with a new PDE value for ethyleneglycol on 26/10/2018. This new version will become effective 1 year after date of publication, from 26/10/2019 (see cover page). Marketing authorisation holders are encouraged to contact the relevant regulatory authorities in case medicinal products are impacted by the abovementioned correction.

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