Issue Date: December 10, 2021
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Final
Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry: Guidance for Industry
This guidance provides recommendations for permitted daily exposures (PDEs) for three additional residual solvents: (1) 2-methyltetrahydrofuran, (2) cyclopentyl methyl ether, and (3) tert-butyl alcohol. This guidance is intended to recommend acceptable amounts for these residual solvents in pharmaceuticals for the safety of the patient. As part of the maintenance process for the ICH guidance for industry Q3C Impurities: Residual Solvents (December 1997), the Q3C PDE levels are added and revised as new toxicological data for solvents become available.
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