In October 2018, the Q3C(R7) guideline was released with a corrected permitted daily exposure (PDE) of 3.1 mg/day for ethylene glycol, replacing ICH Q3C(R6) following an error correction procedure. Now, the ICH Q3C(R6) guideline on impurities in residual solvents has been reinstated, based on archival documents and a review of the literature. The PDE for ethylene glycol is listed again as 6.2 mg/day.

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (2018). ICH Harmonised Guideline. Guideline for residual solvents Q3C(R7). Final version. Dated 20 October 2016. https://database.ich.org/sites/default/files/Q3C-R6_Guideline_ErrorCorrection_2019_0410_0.pdf

 

The above items were taken from the December 2019 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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