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June 2023
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![]() If plastic materials are used for repackaging, the USP requires that these materials should afford better protection than PVC in other words, a Class A- type package is advocated. Pharmacists are expected to maintain the repackaging facility where the dosage forms are stored and repackaged at temperatures such that the mean kinetic temperature (MKT) (see Pharmaceutical Stability (1150) for further discussion on MKT) is not greater than 25° C. When establishing the mean kinetic temperature for a defined period, the formula of J. The mean kinetic temperature is higher than the arithmetic mean temperature and takes into account the Arrhenius equation. Mean Kinetic Temperature - 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.
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