![]() ![]() ![]() MKT integrates the time–temperature history and takes into account the fact that long temperature excursions at slightly elevated temperatures can be just as, or more, impactful than short temperature excursions at elevated temperatures. Mean Kinetic Temperature (MKT) is defined as the 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. Temperature is likely to vary during the life of the product which can impact its degradation rate and stability. ![]() A major consequence of drug product degradation is that the product can fail to maintain its critical quality attributes. Suggested audience: Organizations and individuals involved in the storage and transportation of finished drug products that want to utilize the Mean Kinetic Temperature (MKT) calculation to better understand the impact of temperature excursions.Įstimated proposal PF: Pharmacopeial Forum 45(3) īackground and objective(s): The extent of physicochemical degradation of drug products depends on factors such as product stability, how a product is stored, and how it is packaged. Expert Committee: General Chapters-Packaging and Distribution ![]()
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