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The USP Controlled Room Temperature is a series of United States Pharmacopeia guidelines for the storage of pharmaceuticals; [1] the relevant omnibus standard is USP 797. [2] [3] Although 100% compliance remains challenging for any given facility, [4] the larger protocol may be regarded as constituting a form of clean room [5] which is included in a suite of best practices.
In contrast, ambient temperature is the actual temperature, as measured by a thermometer, of the air (or other medium and surroundings) in any particular place. The ambient temperature (e.g. an unheated room in winter) may be very different from an ideal room temperature .
The USP is published in a combined volume with the National Formulary (a formulary) as the USP-NF. [2] If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF".
The U.S. Pharmacopeia (USP/NF) defines several terms relating to the storage of pharmaceutical products. 20°C to 25°C (68°F to 77°F) is given as the definition of "controlled room temperature", and you will see this listed on many pharmaceutical products. "Warm" is defined as any temperature between 30°C and 40°C (86°F and 104°F).
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The flash point of a material is the "lowest liquid temperature at which, under certain standardized conditions, a liquid gives off vapours in a quantity such as to be capable of forming an ignitable vapour/air mixture". [1] The flash point is sometimes confused with the autoignition temperature, the temperature that causes spontaneous ignition.
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