Stability of prednisone tablets submitted by U.S. hospitals

Abstract

The stability of prednisone tablets that had been stored in hospitals across the United States was studied. Through a voluntary FDA drug stability program, all hospital pharmacies in the United States were asked in October 1982 to complete a response card indicating information about prednisone tablets they had in stock. Based on the responses, FDA selected 117 samples (representing 18 manufacturers and all available tablet strengths) from pharmacies that represented an adequate cross section of the country. The samples were analyzed for content uniformity, strength, identification, dissolution, and the presence of other steroids. All samples met USP requirements for content uniformity and strength. Four samples failed to meet USP requirements for dissolution. Prednisone tablets appear to be stable when stored under actual marketplace conditions.