Module 3 Presentations

07/05/2024

Climate parameters: Mean Kinetic Temperature (MKT)

STEP 1: Activation energy E a is assumed to be 83.144 kJ/mol ● Value, which is recommended in the US Pharmacopeia –

Mean value of published data for more than 100 chemical substances (small molecules that are commonly used as API) – If feasible and in case of biological/biotech products, it is advisable to use the actual activation STEP 2: The activation energy is divided by the universal gas constant R (0.00831432 kJ/°K mol) E a /R = 10000.09622 [°K −1 ] STEP 3: The result is divided by the temperature T n (measured in degrees Kelvin) to get a factor f n for each timepoint F n = e -10000.09622/Tn STEP 4: The sum of the individual results for a defined time period is divided by n, the number of timepoints used. F n = (f1 + f2+· · ·+fn)/n STEP 5: The MKT [°K] for a defined time period is achieved by calculating the negative natural logarithm of the above result using the following equation: MKT = 10000.09622/(−lnF n ) STEP 6: The MKT is converted into degrees Celsius by subtracting 273.1 from the value found.

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

The Organisation for Professionals in Regulatory Affairs

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What are Climatic zones ?

The Organisation for Professionals in Regulatory Affairs

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