Abstract
Parenteral aseptic preparations of hydrocortisone sodium succinate (HSS) are used frequently in hospitals, but little definitive stability information is available. The purpose of this study was to obtain ultimate shelf lives for typical formulations so that they may be prepared in bulk in appropriately licensed facilities. In the first study, the stability of HSS, 1 mg/ml, was determined in polyvinyl chloride (PVC) bags and polyolefine (non-PVC) bags, in 0.9% (w/v) sodium chloride at 7 °C, 25 °C/60% relative humidity (RH) and room temperature in the light (RTL) with storage for up to 135 days. In the second study, the stability of HSS, 50 mg/ml was determined in polypropylene syringes at 5 °C and 25 °C/60% RH with storage for up to 120 days. Samples from each admixture were analysed by stability indicating high performance liquid chromatography (HPLC) and were monitored for pH, appearance of solution and container, and the rate of appearance of decomposition products. Shelf lives were calculated using the maximum rate method. HSS at a concentration of 1 mg/ml in PVC bags was stable for up to 41 days at 7 °C, 8 days at 25 °C and 7 days at RTL. It was stable in non-PVC bags for up to 48, 8 and 6 days, respectively. HSS in polypropylene syringes at a strength of 50 mg/ml was stable for up to 81 days at 5 °C and 6 days at 25 °C.
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