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.
EU ICH Guideline Q3C R6 on Impurities Guideline for Residual Solvents
