Stability of Droperidol 0.625 mg/mL Diluted with 0.9% Sodium Chloride Injection and Stored in Polypropylene Syringes.

The purpose of this study was to determine the stability of droperidol 0.625 mg/mL in 0.9% sodium chloride solution that was packaged in polypropylene syringes and stored at controlled ambient conditions. Samples of droperidol 0.625 mg/mL in 0.9% sodium chloride injection were prepared and assessed for chemical stability using a validated, stability-indicating high-performance liquid chromatographic assay. A total of 18 syringe samples were submitted for chemical stability testing by high-performance liquid chromatography. The syringes were protected from light and stored under controlled ambient conditions (23*C to 27*C; 55% to 65% relative humidity) in an environmental chamber. Three samples were tested initially and at 14-, 30-, 60-, 90-, and 180-day intervals. Each syringe sample assayed once. Additional samples were assessed for pH and inspected for color and visible particulate matter. Stability was defined as the retention of 90% to 110% of the initial drug concentration. Droperidol injection maintained the appearance of a clear, colorless solution, with mean +/- standard deviation. Throughout the study period, pH values ranged from 2.87 +/- 0.02 to 3.29 +/- 0.04. Recovery of fentanyl ranged from 99.9% +/- 0.1% to 103.2% +/- 0.6% of the initial concentration, with no detectable changes in the chromatographic profiles of all tested samples. Droperidol 0.625 mg per milliliter in 0.9% sodium chloride injection, packaged in 1.1-ml aliquots in polypropylene syringes and stored protected from light was stable for 180 days under controlled ambient conditions.