Room Temperature Definition Usp

Pharmacopeia usp has some references usp 659 packaging and storage requirements gives various examples for different storage conditions for example.

Room temperature definition usp.

Pharmacopeia usp has some references usp 659 packaging and storage requirements gives various examples for different storage conditions for example. Usp s current definition of crt states. The usp controlled room temperature is a series of united states pharmacopeia guidelines for the storage of pharmaceuticals. 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 temperature prevailing in a work area. The revision bulletin will be incorporated in usp 41 nf 36. Becoming official in usp 40 nf 35. 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.

Definition of temperature condition. 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. Revision as yet unproposed in pf of usp s definition for controlled room temperature from 20 25 to 2 30. 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 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. 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. 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. 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 between 8 and 15 46 and 59 f room temperature. Any temperature not exceeding 8 c 46 f. Should you have any questions please contact desmond hunt ph d. The temperature prevailing in a work area.

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. Human comfort can extend beyond this range depending on humidity air circulation and other factors. The relevant omnibus standard is usp 797.