Stability and compatibility of reconstituted ertapenem with commonly used i.v. infusion and coinfusion solutions.

PURPOSE

The stability of ertapenem sodium in various commonly used i.v. infusion solutions and its compatibility with coinfusion solutions was studied.

METHODS

Ertapenem was reconstituted with sterile water for injection and then diluted with various commercial i.v. infusion solutions to concentrations of 10 and 20 mg/mL. The solutions were stored in flexible polyvinyl chloride containers at 4 and 25 degrees C and in sterile glass vials at -20 degrees C. The drug's stability at 4 degrees C was monitored daily for up to 10 days, at 25 degrees C at appropriate hourly intervals for up to 30 hours, and at -20 degrees C. The daily for up to 14 days. Compatibility with the coinfusion solutions was monitored for up to eight hours at room temperature. Stability assays were conducted until the ertapenem concentration decreased by 10% or the corresponding degradation products exceeded the approved specifications. Ertapenem concentrations were determined by a stability-indicating high-performance liquid chromatography assay.

RESULTS

Ertapenem was more stable in solutions stored at 4 degrees C versus 25 degrees C. Samples frozen at -20 degrees C showed extreme variability. Ertapenem 10 mg/mL was stable for a longer time than at the 20-mg/mL concentration. Ertapenem demonstrated the greatest stability in 0.9% and 0.225% sodium chloride solutions.

CONCLUSION

Ertapenem sodium injection 10 and 20 mg/mL are relatively stable in sodium chloride injections and Ringer's solution when stored at 25 and 4 degrees C, but are unstable in mannitol and dextrose solutions. The drug can be coinfused with hetastarch, heparin sodium, and potassium chloride over several hours.