What is the Origin of Mean Kinetic Temperature?

The concept originates from physical chemistry and reaction kinetics, specifically applying the Arrhenius equation to the stability of drug substances. Regulatory bodies adopted MKT as a standard quality metric to ensure that fluctuations in temperature do not compromise the chemical integrity of the active pharmaceutical ingredient. This formalized standard is essential for Good Distribution Practice (GDP) compliance.

What is the Mechanism of Mean Kinetic Temperature?

MKT is calculated by assuming the degradation follows first-order kinetics and that the activation energy of the degradation reaction is constant across the observed temperature range. Higher temperatures contribute disproportionately more to the MKT value than lower temperatures, accurately reflecting that degradation reactions accelerate exponentially with increasing heat. This provides a more realistic assessment of product shelf-life and stability.

Mean Kinetic Temperature ∞ Area

Mean Kinetic Temperature

Meaning

Mean Kinetic Temperature (MKT) is a single, calculated temperature value that expresses the cumulative thermal stress exerted on a pharmaceutical product over a period of time at varying temperatures. It is not a simple arithmetic average but a weighted average that emphasizes the effect of temperature excursions on the chemical degradation rate of the product. MKT is a critical metric for assessing the stability and quality of temperature-sensitive hormonal medications during storage and transport.