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News about GMP/cGMP

2018-04-20

ICH Q3C(R7) Guideline for Residual Solvent in Step 1

Almost one year ago, the ICH published its Guideline for Residual Solvents in the version ICH Q3C (R6) introducing new PDE-Levels for Triethylamine and Methylisobutylketone.
Currently, this Guideline is again undergoing maintenance, which shall result in the future Q3C(R7) version, to develop PDE levels for the following three solvents:

 

  • Tert-butanol
  • 2-Methyltetrahydrofuran
  • Cyclopentylmethylether

According to the planned timeline, the document is open for public consultation from June 2018 until December 2018.

In May 2019 it should already be adopted by the Regulatory Members of the Assembly and thus be published as final guideline.

Source:

ICH Q3C Work Plan

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