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Re: Mean Kinetic Temperature?
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Charles, In order to conduct a stability test you do not have to calculate the mean kinetic temperature. If you follow the ICH recommendations (Q1Ar) for storage conditions then the storage conditions take into account the MKT for climatic zones I and II. There is an amendment currently out for comment and if the proposed conditions are adopted they will then also take into account climatic zones III and IV. Regards, Brian Matthews lt09@dial.pipex.com |
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