|
The following are storage definitions, as defined in the General Notices section of the United States Pharmacopoeia (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 to 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°C to 46°C).
- Cool
- Any temperature between 8°C and 15°C (46°F to 59°F). An article that requires cool storage may be stored in a refrigerator, unless otherwise specified by the individual USP monograph.
- Room Temperature
- The temperature prevailing in the workplace.
- Controlled Room Temperature
- A temperature maintained thermostatically that encompasses the usual and customary working environment of 20°C to 25°C (68°F to 77°F) that allows for brief deviations between 15°C and 30°C (59°F to 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°C" 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°F to 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.
|
