The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations. Articles may be labeled for storage at “controlled room temperature” or at “up to 25°”, or other wording based on the same mean kinetic temperature. Spikes above 40° may be permitted if the manufacturer so instructs. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40° are permitted as long as they do not exceed 24 hours. USP 34-NF29 General Notices: Preservation, Packaging, Storage, And LabelingĬontrolled Room Temperature-A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° (68° to 77° F) that results in a mean kinetic temperature calculated to be not more than 25° and that allows for excursions between 15° and 30° (59° and 86° F) that are experienced in pharmacies, hospitals, and warehouses.
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