IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

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
View All Articles in Issue

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

Related Categories: HISTORY, STABILITIES, COMPATIBILITIES, TECHNOLOGY, QUALITY CONTROL, UNITED STATES PHARMACOPEIA CONVENTIONS, STORAGE

Printer-Friendly Version




Download in electronic PDF format for $35

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Mean Kinetic Temperature for Controlled Room Temperature Drug Storage: Official Definitions and Example Calculations Newton David W Jul/Aug 2019 281-287 Buy
PreScription: Stability Studies and United States Pharmacopeia-National Formulary-Grade Chemicals Allen Loyd V Jr Sep/Oct 2016 356 Buy
Five Compounds for Treating Diabetes-Related Conditions Meece Jerry May/Jun 2003 170-174 Buy
Quality-Control Analytical Methods: A Discussion of United States Pharmacopeia Chapter <71> Sterility Tests Kupiec Thomas C Sep/Oct 2007 400-403 Buy
Prescription - Pharmacy and the United States Pharmaceopeia-National Formulary - From the Editor Allen Loyd V Jr May/Jun 2004 162 Buy
Applying Quality of Design Concepts to Pharmacy Compounding Timko Robert J Nov/Dec 2015 453-463 Buy
Quality Control Analytical Methods: Microbial Limit Tests for Nonsterile Pharmaceuticals, Part 1 Vu Nicole, Lou Jessica R, Kupiec Thomas May/Jun 2014 213-221 Buy
Influence of Temperature on the Thirty-Day Chemical Stability of Extemporaneously Prepared Dexamethasone Paste Dudley Richard, McDowell Brean, Mahl Carissa, Sarkar Arindam Basu May/Jun 2012 258-261 Buy
United States Pharmacopeia Chapter <797> Timeline: 1989 to 2013 Newton David W Jul/Aug 2013 283-288 Buy
Quality Assurance and Quality Control: Being Prepared for U.S. Food and Drug Administration Inspections and Staying in Compliance with United States Pharmacopeia Chapter <797>: Part 1 Martin Matt Sep/Oct 2018 401-404 Buy