Room Temperature Definition As Per Usp

In the usp 36 general notices and requirements section 10 30 60 controlled room temperature states that warehouse temperature should be maintained between 20 c to 25 c with excursions allowed between 15 c and 30 c. Interestingly the last sentence in this section allows storage of products in a cool place unless otherwise specified. A change to the usp definition of controlled room temperature would help facilitate the distribution of products remove uncertainty and promote long term value to industry by building a strong foundation of stability data.

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Any temperature between 8 and 15 46 and 59 f room temperature.

Room temperature definition as per usp.

Room temperature storage statements for products with a storage statement reading store at controlled room temperature the labeling should read as follows on the package insert. Any temperature between 8 and 15 46 and 59 f room temperature. Pharmacopeia usp has some references usp 659 packaging and storage requirements gives various examples for different storage conditions for example. In certain fields like science and engineering and within a particular context room temperature can mean different agreed.

Becoming official in usp 40 nf 35. The temperature prevailing in a work area. Any temperature between 8 c and 15 c 46 f to 59 f. Room temperature the temperature prevailing in the workplace.

Any temperature not exceeding 8 c 46 f. An article that requires cool storage may be stored in a refrigerator unless otherwise specified by the individual usp monograph. Any temperature not exceeding 8 c 46 f. Colloquially room temperature is the range of air temperatures that most people prefer for indoor settings which feel comfortable when wearing typical indoor clothing.

This will allow for greater flexibility in how products are distributed promote more efficiencies in distribution and. Human comfort can extend beyond this range depending on humidity air circulation and other factors. Or with requirements in the current edition of an official compendium such as the united states pharmacopeia national formulary usp nf 2 appropriate manual electromechanical or electronic temperature and humidity recording equipment devices and or logs shall be utilized to document proper storage of prescription drugs. Pharmacopeia usp has some references usp 659 packaging and storage requirements gives various examples for different storage conditions for example.

The design of stability studies during pharmaceutical product development and registration takes into account expected supply chain storage and distribution conditions in anticipated markets. Store at 20 c to 25 c 68 f to 77 f excursions permitted between 15 c and 30 c between 59 f and 86 f. The temperature prevailing in a work area. Should you have any questions please contact desmond hunt ph d.

Revision as yet unproposed in pf of usp s definition for controlled room temperature from 20 25 to 2 30. The revision bulletin will be incorporated in usp 41 nf 36. 1 the text of the notice was revised may 17 2017 to clarify that the exemption is being removed from both chapters 661 1 and 661 2.