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What are the significance of MKT in stability study.
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MKT or Mean Kinetic Temperature provides a better
representation of the effects of temperature change on
sensitive materials such as pharmaceuticals during storage
and distribution. MKT can be calculated from a series of
temperatures. It differs from arithmetic mean in that
higher temperatures are given greater weight in computing
the average.
MKT calculation gives increased weighting to higher
temperature excursions than normal arithmetic methods,
recognizing the accelerated rate of thermal degradation of
materials at higher temperatures. It expresses the
cumulative thermal stress experienced by a product at
varying temperatures during storage and distribution.
As defined by the USP, it is a “single calculated
temperature at which the total amount of degradation over a
particular period is equal to the sum of the individual
degradations that would occur at various temperatures”.
As defined by ICH, “A single derived temperature that, if
maintained over a defined period of time, affords the same
thermal challenge to a drug substance or drug product as
would be experienced over a range of both higher and lower
temperatures for an equivalent defined period.”
The mean kinetic temperature is higher than the arithmetic
mean temperature and takes into account the Arrhenius
equation.
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