Transcription of USP Controlled Room Temperature Range Expansion
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USP Controlled Room Temperature Range Expansion
STIMULI TO THE REVISION PROCESS Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts USP Controlled room Temperature Range Expansion Desmond G Hunt,a Chris Chandler,b David A. Ulrich,c Richard Poska,c and Arminda Monteroc ABSTRACT This article provides a brief overview of drug product stability studies and practices with a focus on Temperature control during storage and distribution. Recent stability studies support redefining Controlled room Temperature (CRT) by broadening the permitted Range when appropriate for specific products. The objectives of this Stimuli article are to initiate discussion and solicit public comments regarding a potential revision as yet unproposed in PF of USP's definition for Controlled room Temperature from 20 25 to 2 30 . BACKGROUND The design of stability studies during pharmaceutical product development and registration takes into account expected supply-chain storage and distribution conditions in anticipated markets.
STIMULI TO THE REVISION PROCESS . Stimuli articles do not necessarily reflect the policies . of the USPC or the USP Council of Experts . USP Controlled Room Temperature Range Expansion
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