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News about GMP/cGMP

2018-10-26

ICH Q3C(R7) Published with Correction of PDE for Ethylenglycol

As announced on the ICH website on October 25, the ICH Q3C(R7) Guideline along with Q3C Support Documents 1, 2, and 3 have now been published. The new R7-version of ICH Q3C is the result of an error correction of the Permitted Daily Exposure (PDE) for ethylenglycol as per the correct value calculated in Pharmeuropa, Vol. 9, No. 1, Supplement, April 1997 S36.

 

Ethylenglycol is now listed with a new PDE of 3.1 mg/day and a concentration limit of 310 ppm (before: 6.2 mg/day and 620 ppm).

Furthermore, ICH has published three supporting documents to ICH Q3C which include the summaries of the toxicity data from which PDEs were derived:

  • Toxicological Data for Class 1 solvents
  • Toxicological Data for Class 2 solvents
  • Toxicological Data for Class 3 solvents.
Additional information on the current drafting process of ICH Q3C(R8) was also announced at the same time:

The Q3C(R8) EWG is currently undertaking a maintenance of the Guideline, which will result in the future Q3C(R8) version, to develop PDE levels for three solvents

  • 2-methyltetrahydrofuran
  • cyclopentylmethylether and
  • tert-butanol.

According to the work plan a final version of Revision 8 can be expected by the end of 2019.


Source:

 

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