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USP Quality Review

No. 40, Revised 6/94

Storage Definitions

In some USP monographs, there are specific directions for stating the temperature at which Pharmacopeial articles shall be stored. For example, stability data indicate that storage at a lower or a higher temperature produces undesirable results. These directions apply except where the label on an article specifies a different storage temperature on the basis of stability studies for that particular formulation. The following are storage definitions, as defined in the General Notices section of the USP XXII-NF XVII, for recommended conditions commonly specified on product labels.

  • Freezer—A place in which the temperature is maintained thermostatically between -20° C and -10° C (-4° F and 14° F).
  • Cold—Any temperature not exceeding 8° C (46° F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2° C and 8° C (36°- 46° F).
  • Cool—Any temperature between 8° C and 15° C (46°-59° F). An article that requires cool storage, alternatively may be stored in a refrigerator, unless otherwise specified by the individual USP monograph.
  • Room Temperature—The temperature prevailing in a working area.
  • Controlled Room Temperature—A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° C to 25° C (68°-77° F) that allows for brief deviations between 15° C and 30° C (59°-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. 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. (See the entire revised definition of Controlled Room Temperature in the Ninth Supplement to USP XXII-NF XVII.)
  • Warm—Any temperature between 30° C and 40° C (86°-104° F).
  • Excessive Heat—Any temperature above 40° C (104° F).
  • 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 alteration of its characteristics, the container label must bear an appropriate instruction to protect the article from freezing.