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.