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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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