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.


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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