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.
Also see: Climatic Zones for ICH Stability Studies
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.
Also see: Climatic Zones for ICH Stability Studies
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ReplyDeleteis MKT required for API stability studies? If yes, pl also provide appropriate reason..