Module 3 Presentations

07/05/2024

Climate parameters: Mean Kinetic Temperature (MKT)

MKT is the temperature corresponding to the effects of a given temperature-time distribution on chemical reaction kinetics.

The MKT allows calculating the impact of temperature fluctuations on the chemical degradation of a substance in a given product.

Source: Kim Huynh-Ba, Handbook of Stability Testing in Pharmaceutical Development

The Organisation for Professionals in Regulatory Affairs

37

Climate parameters: Mean Kinetic Temperature (MKT)

The MKT can be calculated by using the formula developed by Haynes based on the Arrhenius equation.

Source: Kim Huynh-Ba, Handbook of Stability Testing in Pharmaceutical Development

The Organisation for Professionals in Regulatory Affairs

38

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