ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Mean Kinetic Temperature (MKT)

Single calculated temperature at which the degradation of an article would be equivalent to the actual degradation that results from actual temperature fluctuations during the storage period. It is not a simple arithmetical mean. The MKT is calculated from average storage temperatures recorded over a one-year period, with a minimum of 12 equally spaced storage temperatures being recorded.

Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007

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