News about GMP/cGMP

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:

• Methylisobutylketone is now listed as a Class 2 solvent  with a PDE of 45 mg/day

• Triethylamine is newly listed as a Class 3 solvent with a PDE of 62,5 mg/day.

Source:

ICH: Newsroom