Long-term stability of ready-to-use epinephrine 0.02 mg/mL injection solution in 50 mL glass vials

Abstract

Abstract Objectives In adult intensive care patients, epinephrine is mostly administered by continuous injection with syringe pumps. The objective of this study was to investigate the physicochemical stability of pharmacy prepared ready-to-use epinephrine (E) 0.02 mg/mL injection solutions (total volume 50 mL) for assigning shelf-life. Methods E 0.02 mg/mL injection solution in 50 mL amber type l glass vials was produced batch-wise in the pharmacy department. Stability of the refrigerated (2–8 °C) product was investigated in real time over a period of 36 months by analyzing E concentrations, osmolality, pH, and sub-visible particles at predefined time-points. For E concentration measurements a stability-indicating, validated reversed-phase HPLC-PDA assay was used. Results The autoclaving process of E 0.02 mg/mL injection solution in 50 mL amber type I glass vials caused 5% loss of the active substance. The finished product remained stable over the study period of 36 months when stored refrigerated. Conclusions Batch-wise production of ready-to-use E injection solution 0.02 mg/mL in 50 mL amber glass vials was successfully implemented in our pharmacy department. According to the stability tests, a shelf-life of 36 months can be assigned to the finished product stored refrigerated. Studies concerning stability at room temperature would be useful.