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Mean Kinetic Temperature for Controlled Room Temperature Drug Storage: Official Definitions and Example Calculations

Author(s):  Newton David W

Issue:  Jul/Aug 2019 - Volume 23, Number 4
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Abstract:  Mean kinetic temperature, a thermodynamically calculated average temperature that is used to determine whether or not the controlled room temperature drug storage limit has been maintained to ensure drug stability, first became official in the Ninth Supplement of the United States Pharmacopeia–National Formulary on November 15, 1993. The calculations involved may appear lengthy, and their mathematic solutions are presented in this article. Also included is a short history on the development of the Arrhenius equation, which is the basis for “mean kinetic temperature,” and the accomplishments of Dr. Svante August Arrhenius.

Related Keywords: David W. Newton, BS Pharm, PhD, FAPhA, drug stability, storage conditions, United States Pharmacopeia–National Formulary, controlled room temperature, Arrhenius equation, chemical reaction rate, calculations, temperature range, quality control


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