Pharma Stability Study

What is the use/application of mean kinetic temperature in stability testing and shelf life determination of pharmaceutical products?

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Temperature can cause product degradation, and product degradation leads to the loss of the product’s critical quality attributes (CQA). The temperature is very probable that it will fluctuate during the life of the product, either at storage or transport, and that will impact product stability.

The mean kinetic temperature can be used in stability testing and shelf life determination by correlating it to the amount of degradation that the product suffered during that time and extrapolate for different conditions.

It is specially useful to evaluate temperature excursions during these studies, so you can establish that the stability was mantained in spite of those temperature excursions which result in a calculated MKT.

Taken from the USP website (Using Mean Kinetic Temperature to Evaluate Temperature Excursions during Storage and Transportation):

MKT integrates the time–temperature history and takes into account the fact that long temperature excursions at slightly elevated temperatures can be just as, or more, impactful than short temperature excursions at elevated temperatures. Thus, MKT is a way to summarize the time-history of a product’s temperature exposure with a single “effective” or “virtual” temperature.

I hope this helps.


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