All posts by Kevin O'Donnell

Industry Stimuli Article Proposes Expanding USP Definition of Controlled Room Temperature

A stimuli article authored by Desmond Hunt, Ph.D., Senior Scientific Liaison at USP, and several members of the pharmaceutical industry has been initiated with the objective to solicit public comment and stimulate discussion regarding a potential revision—as yet unproposed in PF—of USP’s definition for Controlled Room Temperature. The proposal advances the view to expand the current definition of Controlled Room Temperature (CRT) from +20°C to +25°C to +2°C to +30°C. Continue reading