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News|Articles|January 19, 2017
ICH Publishes Presentation on Q3C Revision
Author(s)Pharmaceutical Technology Editors
The presentation details the addition of triethylamine to the guideline on toxic solvents.
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In November 2016, the International Council for Harmonization (ICH) published
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.
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