Stability of terbutaline sulfate repackaged in disposable plastic syringes

Abstract

The stability of terbutaline sulfate injection repackaged in disposable plastic syringes and stored for a 60-day period under one of three conditions, dark at 4 degrees C, dark at 25 degrees C, and light at 25 degrees C, was studied. Terbutaline sulfate from 1-mg/mL ampuls was repackaged into 63 3-mL polypropylene syringes. Twenty-one syringes were protected from light by storage in ultraviolet-light-inhibiting bags in a dark cabinet. Twenty-one syringes were exposed to continuous fluorescent light at room temperature, and the remaining syringes were stored in the dark under refrigeration. Samples were visually inspected and assayed on days 0, 1, 4, 7, 14, 28, and 60 after repackaging. Drug concentrations were determined by a stability-indicating high-performance liquid chromatographic method. Terbutaline concentrations ranged from 89.2% to 98.5% of initial concentration. The contents of the light-exposed syringes had yellowed by day 60. Terbutaline sulfate in polypropylene syringes is stable for 60 days under refrigeration and at room temperature when protected from light, but substantial degradation and discoloration of the drug can occur when the syringes are not protected from light.