News about GMP/cGMP

05.12.2016

Final: ICH Q3C Guideline for Residual Solvents

The ICH Q3C(R6) Guideline “Impurities: Guideline for Residual Solvents” reached Step 4 of the ICH Process in November 2016 and now enters into the implementation period (Step 5).

 

Based on new toxicological data, the most recent maintenance of the ICH Q3C Guideline revises the PDE for Methyl isobutyl ketone (MIBK), and adds Triethylamine (TEA) as a new solvent.

The PDE for Triethylamine and Methylisobutylketone document has been integrated as Part V (page 26) in the core Q3C(R5) Guideline which was then renamed Q3C(R6). The Table 2, Table 3 and Appendix 1 have been updated to reflect the revision of the PDE for Triethylamine and Methylisobutylketone:

  • Methylisobutylketone is now listed as a Class 2 solvent  with a PDE of 45 mg/day
  • Triethylamine is newly listed as a Class 3 solvent with a PDE of 62,5 mg/day.

Source:

ICH: Newsroom

 



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