Stability of betamethasone sodium phosphate, hydrocortisone sodium phosphate, and prednisolone sodium phosphate injections submitted by U.S. hospitals.
The stability of betamethasone sodium phosphate, hydrocortisone sodium phosphate, and prednisolone sodium phosphate, injections stored in hospital pharmacies across the United States was studied. Through a voluntary drug stability program, FDA selected 58 samples (representing two manufacturers) from pharmacies representing a cross section of the country. The samples were analyzed for strength, identification, pH, and related impurities. All of the hydrocortisone sodium phosphate and prednisolone sodium phosphate samples met USP requirements for strength and pH. Assays of the betamethasone sodium phosphate injection samples yielded results that were in compliance with the manufacturer's strength and pH limits; there are no USP requirements for betamethasone sodium phosphate injection. All samples were within USP limits for related free steroids. Betamethasone sodium phosphate, hydrocortisone sodium phosphate, and prednisolone sodium phosphate injections obtained from hospital pharmacies appear to be stable after storage under actual marketplace conditions.
D001623:Betamethasone / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D006761:Hospitals; D006854:Hydrocortisone / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D007267:Injections; D011239:Prednisolone / Q000032:analysis*; D014481:United States; D014486:United States Food and Drug Administration
D001623:Betamethasone; D011239:Prednisolone; D006854:Hydrocortisone