Room temperature: The temperature prevailing in a work area.Cool: Any temperature between 8° and 15° (46° and 59 ☏).Cold: Any temperature not exceeding 8☌ (46 ☏).
Pharmacopeia (USP) has some references.USP “Packaging and Storage Requirements” gives various examples for different storage conditions, for example: It means “room temperature” or normal storage conditions, which means storage in a dry, clean, well ventilated area at room temperatures between 15° to 25☌ (59°-77☏) or up to 30☌, depending on climatic conditions.Īnd the U.S. This term is not widely used due to significant variation in ambient temperatures.
Ambient temperature: Store at the surrounding temperature. Store at 2°-8☌ (36°-46☏): for heat sensitive products that must not be frozen. Store frozen: transported within a cold chain and stored at -20☌ (4☏). There are also some definitions in the WHO Guidance : The European Pharmacopoeia (Pharm.Eur.) gives some hints in chapter 1.2 (Other provisions applying to general chapters and monographs) with referring to analytical procedures: But according to the PIC/S Good Distribution Guide these conditions should also be applied for transportation ( see section 9.2.1). The required storage conditions for medicinal products should be maintained during transportation within the defined limits as described by the manufacturers or on the outer packaging.” (EU GDP Guidelines). On the outer packaging of pharmaceutical products one often finds labels with storage requirements like, for example, “ambient”, “room temperature” and “cold chain”. 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 label bears an appropriate instruction to protect the article from freezing.Regulatory Definitions for “Ambient”, “Room Temperature” and “Cold Chain” Excessive Heat – Any temperature above 40°. 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. The mean kinetic temperature is acalculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations. Articles may be labeled for storage at “controlled room temperature” or at “up to 25°”, or other wording based on the same mean kinetic temperature. Controlled Room Temperature- temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° (68° to 77° F) that results in a mean kinetic temperature calculated to be not more than 25° and that allows for excursions between 15° and 30° (59° and 86° F) that are experienced in pharmacies, hospitals, and warehouses. Room Temperature-The temperature prevailing in a working area. An article for which storage in a cool place is directed may, alternatively, be stored in a refrigerator, unless otherwise specified by the individual monograph. A refrigerator is a cold place in which the temperature is maintained thermostatically between 2° and 8° (36° and 46° F). Definition of temperature condition Freezer- A place in which the temperature is maintained thermostatically between – 20° and -10°(-4° and 14° F) Cold- Any temperature not exceeding 8° (46° F). 
Such that directions apply except the label on drug states different storage temperature on the basis of stability studies of that particular formulation. The USP/NF has set specific directions in temperatures of articles that stability data indicate that storage at lower or a higher temperature produces undesirable results. Because drugs are temperature dependent and a factor which cause them to deteriorate and spoil, storage temperature must be well sustained and controlled.
Storage temperature is very important in maintaining the efficacy, potency and stability of drugs.
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