ICH Publishes Presentation on Q3C Revision

In November 2016, the International Council for Harmonization (ICH) published Q3C(R6), which added triethylamine (TEA) to the guideline on the use of toxic solvents in the manufacture of drug substances and dosage forms. The revision also addressed new data regarding methyl isobutyl ketone (MIBK). On Jan. 19, 2017, ICH uploaded a presentation on the revision to its website.

The presentation outlines the toxicological data and permitted daily exposure (PDE) of both TEA and MIBK. The presentation states that the proposed PDE for TEA is 62.5 mg per day and it has been placed into Class 3. MIBK has been placed into Class 2 and has a proposed PDE of 45 mg per day. More information can be found in the presentation and in the guideline.

Source: ICH