Storage Condition of Pharmaceutical Products
To ensure the stability of a pharmaceutical preparation for the period of its intended shelf life, the product must be stored in proper conditions. The labeling of each product includes the desired conditions of storage. The terms generally employed in such labeling have meanings defined by the USP (15):
Cold: Any temperature not exceeding 8°C (46°F). A refrigerator is a cold place in which the temperature is maintained thermostatically between 2° and 8°C (36° and 46°F). A freezer is a cold place in which the temperature is maintained thermostatically between −25° and −10°C (−13° and 14°F).
Cool: Any temperature between 8° and 15°C (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 in the individual monograph.
Room temperature: The temperature prevailing in a working area. A controlled room temperature encompasses the usual working environment of 20° to 25°C (68° to 77°F) but also allows for temperature variations between 15°C and 30°C (59° and 86°F) that may be found in pharmacies, hospitals, and drug warehouses.
Room temperature: The temperature prevailing in a working area. A controlled room temperature encompasses the usual working environment of 20° to 25°C (68° to 77°F) but also allows for temperature variations between 15°C and 30°C (59° and 86°F) that may be found in pharmacies, hospitals, and drug warehouses.
Warm: Any temperature between 30° and 40°C (86° and 104°F).
Excessive heat: Above 40°C (104°F).
Protection from freezing: Where in addition to the risk of breakage of the container, freezing subjects a product to loss of strength or potency or to destructive alteration of the dosage form, the container label bears an appropriate instruction to protect the product from freezing.
Source: Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems (Ninth Edition)
