Abstract
The stability of ranitidine hydrochloride stored frozen and refrigerated in polyvinyl chloride minibags was studied. Ranitidine hydrochloride was added to either 5% dextrose injection or 0.9% sodium chloride injection to yield concentrations of 0.5, 1.0, and 2.0 mg/mL. In phase 1 of the study, admixtures containing ranitidine hydrochloride 1 mg/mL were stored at 4 degrees C for 10 days. In phase 2, solutions were frozen for 30 days at -30 degrees C and were later refrigerated for 14 days. Ranitidine concentration was tested using a stability-indicating high-performance liquid chromatographic assay at time zero and at intervals during storage. Sterility tests were performed on some samples, and various admixtures were visually inspected and tested for pH. At least 90% of the initial concentration of ranitidine remained in all solutions at all storage conditions. No visual changes or changes in pH or sterility were observed. Ranitidine hydrochloride in concentrations of 0.5, 1.0, and 2.0 mg/mL in 5% dextrose injection or 0.9% sodium chloride injection may be stored in polyvinyl chloride minibags frozen for 30 days followed by refrigeration for an additional 14 days.
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