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In the October 16, 2015, Federal Register, FDA
announced the availability of draft recommendations for a new
permitted daily exposure ("PDE") for the residual solvent
triethylamine and a revised PDE for the residual solvent
methylisobutylketone, according to the maintenance procedures for
the guidance for industry titled "Q3C Impurities: Residual Solvents."
The document is intended to recommend acceptable amounts for the
listed residual solvents in pharmaceuticals for the safety of the
patient. Comments due December 15, 2015.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
