STABILITY OF MIDAZOLAM HYDROCHLORIDE IN A FLAVORED, DYE-FREE ORAL SOLUTION

The stability of injectable midazolam hydrochloride in a solution for oral use was studied at three temperatures over 56 days. A 2.5-mg/mL oral solution was prepared from injectable midazolam hydrochloride and a flavored, dye-free syrup. Samples of solution were stored in amber glass bottles at 7, 20, or 40-degrees-C. Duplicate samples were analyzed by high-performance liquid chromatography on days 0, 1, 3, 5, 14, 21, 35, and 56. Samples were also visually inspected on each sampling day. The concentrations of all samples remained greater than 90% of the original concentration and there were no visual signs of microbial growth or changes in color, turbidity, or odor throughout the 56-day period. A 2.5-mg/mL solution of injectable midazolam in syrup was stable for 56 days at 7, 20, or 40-degrees-C.