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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