GMP USP/NF Storage Temperature
Storage temperature is very important in maintaining the efficacy, potency and stability of drugs. Because drugs are temperature dependent and a factor which cause them to deteriorate and spoil, storage temperature must be well sustained and controlled. The USP/NF has set specific directions in temperatures of articles that stability data indicate that storage at lower or a higher temperature produces undesirable results. Such that directions apply except the label on drug states different storage temperature on the basis of stability studies of that particular formulation.
Definition of temperature condition
Freezer- A place in which the temperature is maintained thermostatically between – 20° and -10°(-4° and 14° F)
Cold- Any temperature not exceeding 8° (46° F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2° and 8° (36° and 46° F).
Cool- Any Temperature between 8° and 15° (46° and 59° F). An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator, unless otherwise specified by the individual monograph.
Room Temperature-The temperature prevailing in a working area.
Controlled Room Temperature- 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. 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. The mean kinetic temperature is acalculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations.
An article for which storage at Controlled room temperature is directed may, alternatively, be stored in a cool place, unless otherwise specified in the individual monograph or on the label.
Warm- Any temperature between 30° and 40° (86° and 104° F).
Excessive Heat – Any temperature above 40°.
Protection from Freezing – Where, in addition to the risk of breakage of the container, freezing subjects an article to loss of strength or potency, or to destructive label bears an appropriate instruction to protect the article from freezing.