![]() 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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