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.
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