19 January 2017

The Q3C Guideline recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products. In 2014, the Maintenance Expert Working Group proposed to add a new solvent Triethylamine (TEA), and to revisit the existing PDE of the solvent Methylisobutylketone (MIBK) as new toxicological data for this solvent became available. The Q3C(R6) including TEA and MIBK was adopted by the Assembly in November 2016.

Please now find on the Q3C page a presentation on Q3C(R6) Guideline available for you.