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.
Room temperature definition as per usp.
The revision bulletin will be incorporated in usp 41 nf 36.
Revision as yet unproposed in pf of usp s definition for controlled room temperature from 20 25 to 2 30.
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.
In certain fields like science and engineering and within a particular context room temperature can mean different agreed.
Any temperature between 8 and 15 46 and 59 f room temperature.
Should you have any questions please contact desmond hunt ph d.
Becoming official in usp 40 nf 35.
Colloquially room temperature is the range of air temperatures that most people prefer for indoor settings which feel comfortable when wearing typical indoor clothing.
The design of stability studies during pharmaceutical product development and registration takes into account expected supply chain storage and distribution conditions in anticipated markets.
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.
Pharmacopeia usp has some references usp 659 packaging and storage requirements gives various examples for different storage conditions for example.
The temperature prevailing in a work area.
Interestingly the last sentence in this section allows storage of products in a cool place unless otherwise specified.
Any temperature between 8 c and 15 c 46 f to 59 f.
Pharmacopeia usp has some references usp 659 packaging and storage requirements gives various examples for different storage conditions for example.
Human comfort can extend beyond this range depending on humidity air circulation and other factors.
Any temperature between 8 and 15 46 and 59 f room temperature.
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.
Any temperature not exceeding 8 c 46 f.
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.
The temperature prevailing in a work area.
Room temperature the temperature prevailing in the workplace.
