Stability Study of Hydromorphone Hydrochloride Under Different Conditions
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Graphical Abstract
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Abstract
OBJECTIVE To investigate the stability of hydromorphone hydrochloride solution in different conditions in order to provide the references information for rational drug in clinical practice. METHODS In a simulated clinical situation, hydromorphone hydrochloride was undergone appropriate dilution with 0.9% sodium chloride injection and was stockpiled in infusion bags(PVC), infusion bags(non-PVC) or drug infusion pumps(PVC). Then HPLC was employed to determine hydromorphone concentrations at 0, 1, 2, 3, 5, 7, 9, 11, 13, 15, 17 d under 25℃ or 37℃. The appearance was observed and the pH was measured. RESULTS No notable changes in pH or appearance were observed at different temperatures, different time and implantable infusion system for 15 d. CONCLUSION It is appropriate that 0.05 mg·mL-1 hydromorphone hydrochloride is in 40 mL 0.9% sodium chloride injection in different implantable infusion system to keep stable for at least 10 d from the perspective of drug stability.
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