Table 1.
Label | Temperature details as per USP |
---|---|
Freezer | Indicates a place in which the temperature is maintained thermostatistically between −25 and −10 °C |
Cold | Any temperature not exceeding 8 °C. The “refrigerator” is a cold place in which the temperature is maintained between 2 and 8 °C |
Cool | Any temperature between 8 and 15 °C |
Control room temperature | A temperature maintained between 20 and 25 °C, that results in a mean kinetic temperature (MKT) calculated not to be more than 25 °C and that allows EXCURSIONS between 15 and 30 °C |