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# ICH Revised Guideline on Residual Solvents
- URL: https://www.fdaweb.com/ich-revised-guideline-on-residual-solvents/
- Published: 2021-04-23T12:00:00.000Z
- Updated: 2026-09-14T16:56:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149181

The International Conference for Harmonization (ICH) has released for adoption a [revised guideline](https://database.ich.org/sites/default/files/ICH%5FQ3C-R8%5FGuideline%5FStep4%5F2021%5F0422%5F1.pdf?ref=fdaweb.com) entitled *ICH Q3C(R8) Guideline on Impurities: Guideline for Residual Solvents*. The document was revised to include the permitted daily exposure levels for three solvents — 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary butyl alcohol. Additionally, an introductory training [presentation](https://database.ich.org/sites/default/files/ICH%5FQ3C-R8%5FStep4%5FPresentation%5F2021%5F0422.pdf?ref=fdaweb.com) on the document has also been developed by ICH’s Maintenance Expert Working Group.