Definition of Pharmaceutical Storage Temperature and Conditions
Freezer: A place where the temperature is controlled between −25° and −10° (−13° and 14° F). Some articles may need storage below −20° (−4° F), with the temperature controlled to ±10° of the recommended condition.
Refrigerator: A cold place with a temperature controlled between 2° and 8° (36° and 46° F).
Cold: Any temperature not exceeding 8° (46° F).
Cool: Any temperature between 8° and 15° (46° and 59° F). Articles for cool storage may also be stored and shipped refrigerated unless specified otherwise.
Room temperature: The temperature prevailing in a working environment.
Controlled cold temperature: Thermostatically maintained between 2° and 8° (36° and 46° F), allowing for excursions between 2° and 15° (36° and 59° F) for up to 24 hours, with a mean kinetic temperature (MKT) not exceeding 8° (46° F).
Controlled room temperature: Thermostatically maintained between 20° and 25° (68° and 77° F), with MKT not exceeding 25° (77° F) during excursions between 15° and 30° (59° and 86° F) for up to 24 hours.
Warm: Any temperature between 30° and 40° (86° and 104° F).
Excessive heat: Any temperature above 40° (104° F).
Dry place: A place with an average relative humidity not exceeding 40% at 20° (68° F), or equivalent water vapor pressure at other temperatures. Storage in a container that protects from moisture is considered a dry place.
Do not refrigerate: Indicates that refrigeration could cause loss of strength, potency, or destructive
alteration of the article’s characteristics.
Protect from freezing: Indicates that freezing could cause loss of strength, potency, or destructive alteration of the article’s characteristics, and may risk container breakage.
Protect from light: Indicates that exposure to light could cause loss of strength, potency, or destructive alteration of the article’s characteristics, requiring packaging in a light-resistant container.
Reference: USP monograph 〈659〉 Packaging and Storage Requirements
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