Mean Kinetic Temperature MKT

An additional parameter, which is including the reaction rate constants in the evaluation of the impact of heat on pharmaceutical products, is the Mean Kinetic Temperature (MKT). The MKT was calculated by applying an equation derived by Haynes [11] based on the Arrhenius equation. At first, the activation energy Ea (assumed to be 83.144 kJ/mol) is divided by the universal gas constant R, the result is then divided by the temperature at each time point and place per day measured in degrees 

Celsius after conversion into degrees Kelvin by adding 273.1 to get four different values per day. 

After that, the sum of these four results is divided by 4. 

Then the mean kinetic temperature per day for each month (MKTd) is achieved by calculating the negative natural logarithm of the above result, converted into degrees Celsius, using the following equation  

The mean value per year is achieved by calculating the sum of all 48 f values (= four times per day x 12 months) and applying the equation for MKTd described above to the 48 values  

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Pharmacists are expected to maintain the repackaging facility where the dosage forms are stored and repackaged at temperatures such that the mean kinetic temperature (MKT) (see Pharmaceutical Stability (1150) for further discussion on MKT) is not greater than 25° C. If plastic materials are used for repackaging, the USP requires that these materials should afford better protection than PVC in other words, a Class A-type package is advocated. 

Mean kinetic temperature A single derived temperature which, if maintained over a defined period, would afford the same thermal challenge to an API or drug product as would have been experienced over a range of both higher and lower temperatures for an equivalent defined period. The mean kinetic temperature (MKT) is higher than the arithmetic mean temperature and takes the Arrhenius equation into account. 

MKT = Mean Kinetic Temperature, calculated as described above. 

European Compliance Academy. GMP News 07/05/2014. http // www.gmp-compliance.org/enews 04209 GDP-Question-When-to-use-Mean-Kinetic-Temperature-Calculation-MKT-.html... 

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