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.
The first solvent, 2-methyltetrahydrofuran, is used as a catalytic solvent instead of tetrahydrofuran. Cyclopentyl methyl ether, also used in lieu of tetrahydrofuran, is also an analog to tert-butyl methyl ether. Tert-, or tertiary-butyl alcohol, is used for purposes including denaturing alcohol, as a dehydration agent and as a solvent.
The Q3C(R8) draft guideline was endorsed by the ICH Assembly in March and is expected to be adopted later this year following local consultations by ICH members. Once adopted, ICH members will finalize the guideline and implement it in their jurisdictions.
The European Medicines Agency (EMA), China’s National Medical Products Administration (NMPA) and the Taiwan Food and Drug Administration (TFDA) have all began their public consultations, with comments expected by the end of July.
Federal Register Notice