Stability of Vancomycin Hydrochloride in MEDICATION CASSETTE

Each product intended for storage and administration in drug-delivery devices shoud be studied to determine its compatibility and stability with the device. The purpose of this tudy was to determine the stability of 20-mg/mL and 40-mg/mL concentrations of vancomycin hydrocholoride in 5% dextrose in water when prefilled in SIMS Deltec MEDICATION CASSETTE reservoirs and stored at 5 deg C for up to 30 days and at 25 deg C for up to 96 hours. The solutions were prepared as per the manufacturer's directions and further diluted with 5% dextrose in water to concentrations of 20 mg/mL and 40 mg/mL. Six each of both 50-mL and 100-mL reservoirs were filled and stored at either 5 deg C or 25 deg C and were sampled at selected intervals. A stability-indicating high-performance liquid chromatography assay was used to determine the drug concentration. The results show that vanconmycin hydrochloride at concentrations of 20mg/mL and 40 mg/mL in 5% dextrose in water can be packaged in either 50-mL or 100-mL SIMS Deltec MEDICATION CASSETTE reservoirs and stored at 25 deg C for 96 hours or at 5 deg C for 30 days with less than about 3% loss in potency.