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.
Room temperature definition usp.
Room temperature the temperature prevailing in a working area.
The design of stability studies during pharmaceutical product development and registration takes into account expected supply chain storage and distribution conditions in anticipated markets.
Although 100 compliance remains challenging for any given facility the larger protocol may be regarded as constituting a form of clean room which is included in a suite of best practices.
The temperature prevailing in a work area.
Any temperature between 8 and 15 46 and 59 f room temperature.
Usp s current definition of crt states.
Pharmacopeia usp has some references usp 659 packaging and storage requirements gives various examples for different storage conditions for example.
The revision bulletin will be incorporated in usp 41 nf 36.
Definition of temperature condition.
Human comfort can extend beyond this range depending on humidity air circulation and other factors.
Any temperature not exceeding 8 c 46 f.
Should you have any questions please contact desmond hunt ph d.
Controlled room temperature see storage temperature and humidity in preservation packaging storage and labeling under general notices and requirements delineates the allowable tolerance in storage circumstances at any location in the chain of distribution e g pharmacies hospitals and warehouses this terminology also allows patients or consumers to be counseled as to appropriate.
The usp controlled room temperature is a series of united states pharmacopeia guidelines for the storage of pharmaceuticals.
The temperature prevailing in a work area.
Pharmacopeia usp has some references usp 659 packaging and storage requirements gives various examples for different storage conditions for example.
The temperature maintained at the usual and customary working environment of 20 25 c but it is weighted down with a host of conditions and caveats and its lack of clarity has led to numerous debates on its intent and application and long stymied shipping and distribution practices.
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 relevant omnibus standard is usp 797.
Revision as yet unproposed in pf of usp s definition for controlled room temperature from 20 25 to 2 30.
Any temperature not exceeding 8 c 46 f.
Any temperature between 8 and 15 46 and 59 f room temperature.
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.
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.
