Biomaterial Database

Stability of betamethasone sodium phosphate, hydrocortisone sodium phosphate, and prednisolone sodium phosphate injections submitted by U.S. hospitals. 1986

M A Kreienbaum

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.

UI	MeSH Term	Description	Entries
D007267	Injections	Introduction of substances into the body using a needle and syringe.	Injectables,Injectable,Injection
D011239	Prednisolone	A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.	Di-Adreson-F,Predate,Predonine,Di Adreson F,DiAdresonF
D002851	Chromatography, High Pressure Liquid	Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed.	Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D004355	Drug Stability	The chemical and physical integrity of a pharmaceutical product.	Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D006761	Hospitals	Institutions with an organized medical staff which provide medical care to patients.	Hospital
D006854	Hydrocortisone	The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.	Cortef,Cortisol,Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-,11-Epicortisol,Cortifair,Cortril,Epicortisol,Hydrocortisone, (11 alpha)-Isomer,Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer,11 Epicortisol
D006863	Hydrogen-Ion Concentration	The normality of a solution with respect to HYDROGEN ions; H+. It is related to acidity measurements in most cases by pH	pH,Concentration, Hydrogen-Ion,Concentrations, Hydrogen-Ion,Hydrogen Ion Concentration,Hydrogen-Ion Concentrations
D001623	Betamethasone	A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724)	Betadexamethasone,Flubenisolone,Celeston,Celestona,Celestone,Cellestoderm
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014486	United States Food and Drug Administration	An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc.	Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration