Mean Kinetic Temperature (MKT) in Stability Studies : Pharmaceutical Guidelines

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Mean Kinetic Temperature (MKT) in Stability Studies

Learn how to calculate the Mean Kinetic Temperature (MKT) in ICH stability testing of pharmaceutical products.
Mean Kinetic Temperature is a useful tool used in pharmaceutical stability studies. It helps to calculate the degradation of stability sample.

As per ICH guidelines Mean Kinetic Temperature can be defined as a single calculated temperature which degrades the same amount of the drug as degraded by the different temperatures during the particular time period.

MKT is not a simple arithmetic mean but is calculated from the temperatures of stability chambers. Many software programs are available that stores the temperature from the stability chambers and also calculate the mean kinetic temperature directly.
Related: Guidelines for Pharmaceutical Stability Study

Degradation of any drug totally depends upon its storage temperature. When tablets are stored in a stability temperature, its temperature does not remain constant always. It varies up and down from the set temperature.

Suppose we set a stability chamber at 30°C but it shall be 29.4, 29.8 or 30.6 many times in the specified period of time and we found the degradation of the drug by 0.6% in that period. Now mean kinetic temperature is calculated to determine the single temperature at which the drug would degrade by 0.6% in that period.
Also see: Climatic Zones for ICH Stability Studies





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


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  1. Pl inform
    is MKT required for API stability studies? If yes, pl also provide appropriate reason..

    ReplyDelete


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