USA – FDA consults on ICH residual solvents update

The US Food and Drug Administration (FDA) on Tuesday launched a two-month public consultation on an International Council for Harmonisation (ICH) guideline establishing new permitted daily exposures (PDEs) for three residual solvents.

Specifically, the ICH Q3C(R8) guideline is a product of the maintenance procedure for updating ICH’s guideline for residual solvents as new toxicological data for become available. The eighth revision to the guideline adds PDEs for three new solvents, 2-methyltetrahydrofuran, cyclopentyl methyl ether and tert-butyl alcohol. Specific PDEs for these residual solvents, FDA said, “were developed according to the methods for establishing exposure limits” found in the Q3C guideline…