title: Stability of hydrocortisone sodium succinate after reconstitution in 0.9% sodium chloride injection and storage in polypropylene syringes for pediatric use.
abstract: The stabilty of hydrocortisone sodium succinate (10 mg/mL) in 0.9% sodium chloride injection has been studied at 25 deg C and 5 deg C in polypropylene syringes by means of a stabililty-indicating high-performance liquid chromatography assay method. The concentration of the drug was directly related to the peak height, and the percent relative standard deviation based on 5 injections was 1.2. Benzyl alcohol, which was added as a preservative, did not interfere with the assay procedure. Two products of decomposition separated from the intact drug. At 25 deg C, the loss in potency was less than 10% after 7 days of storage. At 5 deg C, it was less than 3% when stored for 21 days. The pH value of the injection decreased from 7.2 to 6.3 when stored at 25 deg C for 21 days and from 7.2 to 7.0 when stored at 5 deg C for 21 days. The drug did not adsorb onto the syringes, and the physical appearance of the injection did not change.
authors: Pharmaceutics Division, University of Houston, Houston, TX.
authors: V D
authors: VD
authors: Gupta
authors: J
authors: J
authors: Ling