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# ICH Guide on Residual Solvents
- URL: https://www.fdaweb.com/ich-guide-on-residual-solvents/
- Published: 2021-12-10T12:00:00.000Z
- Updated: 2026-09-14T17:25:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150751

FDA has posted an International Council for Harmonization guidance entitled *Q3C(R8) Impurities: Guidance for Residual Solvents*. The document provides recommendations for permitted daily exposures for three residual solvents: (**1**) 2-methyltetrahydrofuran, (**2**) cyclopentyl methyl ether, and (**3**) tert-butyl alcohol. It is intended to recommend acceptable amounts for these residual solvents in pharmaceuticals that will provide adequate patient safety. To view the guidance, click [here](https://www.fda.gov/media/138334/download?ref=fdaweb.com).