The draft revised ICH Guideline for Residual Solvents Q3C(R8) has now been released to the regulatory authorities of the ICH regions for internal and external consultation (“Step 2b”). This document only contains information on three solvents, 2-methyltetrahydrofuran, cyclopentyl methyl ether and tert-butanol, for which respective permitted daily exposure (PDE) values of 50, 15 and 35 mg/day were proposed.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (2020). ICH Harmonised Guideline. Impurities: guideline for residual solvents Q3C(R8). PDE for 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary-butyl alcohol. Draft version. Endorsed on 25 March 2020. Currently under public consultation.


The above items were taken from the May 2020 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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