Based on new toxicological data, the most recent maintenance of the ICH Q3C Guideline revises the PDE for Methyl isobutyl ketone (MIBK), and adds Triethylamine (TEA) as a new solvent.
The PDE for Triethylamine and Methylisobutylketone document has been integrated as Part V (page 26) in the core Q3C(R5) Guideline which was then renamed Q3C(R6). The Table 2, Table 3 and Appendix 1 have been updated to reflect the revision of the PDE for Triethylamine and Methylisobutylketone:
Source:
ICH: Newsroom
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