Cimetidine hydrochloride compatibility. I: Chemical aspects and room temperature stability in intravenous infusion fluids

Abstract

The visual and chemical stabilities of cimetidine hydrochloride in solution with frequently prescribed large-volume parenteral fluids were studied. Cimetidine hydrochloride was added aseptically to each of 22 intravenous fluid products in glass or polyvinyl chloride containers to final concentrations of 120 and 500 mg/100 ml. The solutions were stored at approximately 25 degrees C. At 0, 24, 48, 72, and 168 hours (1 week) after mixing, the solutions were examined for color, odor, and clarity; pH values were measured; and the cimetidine contents were determined by high-pressure liquid chromatography. The solutions showed no changes in odor, color, or clarity. The pH values remained relatively invariant, except for slight increases in the 5% dextrose and in the Aminosyn 3.5% M solutions (120 mg/100 ml) and the 10% Travert Injection (500 mg/100 ml). Cimetidine content remained steady in all solutions. Cimetidine hydrochloride is visually and chemically stable for at least one week at ambient temperatures when combined with commonly used intravenous fluids in concentrations of 120 and 500 mg/100 of solution.