On 6 December 2016 the European Medicines Agency issued a revision to the “ICH guideline Q3C (R6) on Impurities: Guideline for Residual Solvents”. This included the revision of Permissible Daily Exposure (PDE) information for Methylisobutylketone contained in the Parent Guideline and includes a PDE for Triethylamine. Table 2, Table 3 and Appendix 1 of the Parent Guideline have been updated to reflect the revision of the PDE for Triethylamine and Methylisobutylketone. This revision is effective 14 June 2017.
