Stability of sterile dexamethasone acetate suspensions and dexamethasone sodium phosphate injections submitted by U.S. hospitals.
The stability of sterile dexamethasone acetate suspensions and dexamethasone sodium phosphate injections that had been stored in hospital pharmacies across the United States was studied. Through a voluntary FDA drug stability program, all hospital pharmacies in the United States were asked in October 1981 to complete a response card indicating information about the sterile dexamethasone acetate suspensions and dexamethasone sodium phosphate injections they had in stock. Based on the responses, FDA selected 21 samples of sterile dexamethasone acetate suspensions (representing two manufacturers) and 114 samples of dexamethasone sodium phosphate injection (representing 11 manufacturers). These samples were analyzed for identification, pH, and strength. All samples of sterile dexamethasone acetate suspension met USP requirements. Eleven samples of dexamethasone sodium phosphate injection representing 10 lots from three manufacturers failed USP assay requirements for strength. All samples that failed to meet strength requirements showed evidence of degradation by oxidation. Sterile dexamethasone acetate suspensions appear to be stable when stored under actual marketplace conditions, but there is a problem with the shelf-life stability of dexamethasone sodium phosphate injections made by some manufacturers.
D003907:Dexamethasone / Q000031:analogs & derivatives*; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007267:Injections; D010607:Pharmacy Service, Hospital; D013535:Suspensions; D014481:United States
D013535:Suspensions; C004180:dexamethasone 21-phosphate; D003907:Dexamethasone; C018038:dexamethasone acetate