USP Quality Review

No. 61, Issued 03/98

References

  1. USP Subcommittee on Packaging, Storage, and Distribution. Survey to Provide Data for Proper Shipment and Distribution Conditions. Pharmacopeial Forum 1996;22(6):3268­3269.

  2. "Controlled Room Temperature--A temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° (68° to 77° F); that results in a mean kinetic temperature calculated to be not more than 25°; and that allows for excursions between 15° and 30° (59° and 86° F) that are experienced in pharmacies, hospitals, and warehouses. Articles may be labeled for storage at 'controlled room temperature' or at 'up to 25°,' or other wording based on the same mean kinetic temperature that simulates the nonisothermal effects of storage temperature variations." USP 23­NF 18, United States Pharmacopeial Convention, Inc. Rockville, MD; 1995:11.

  3. Okeke CC, Bailey LC, Medwick T, Grady LT. Temperature Fluctuations During Mail Order Shipment of Pharmaceutical Articles Using Mean Kinetic Temperature Approach. Pharmacopeial Forum 1997;23(3):4155

  4. Okeke CC, Barletta FP, Gray VA, et al. A Review of Storage Conditions for Compendial Dosage Forms. Pharmacopeial Forum 1997;23(4):4565­4580.

  5. USP 23­NF 18, United States Pharmacopeial Convention, Inc. Rockville, MD; 1995:11.

  6. Seventh Supplement to USP 23 and to NF 18. U.S. Pharmacopeial Convention, Inc., Rockville, MD: 1997:3840-3843.