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Physical and Chemical Stability of Palonosetron Hydrochloride with Fluorouracil and with Gemcitabine Hydrochloride during Simulated Y-site Administration

Author(s):  Trissel Lawrence A, Zhang Yanping

Issue:  Jul/Aug 2005 - Human Hormone Replacement Therapy
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Abstract:  The objective of this study was to evaluate the physical and chemical stability of undiluted palonosetron 50 µg/mL as the hydrochloride with fluorouracil 16 mg/mL, and with gemcitabine 10 mg/mL as the hydrochloride, in 5% dextrose injection during simulated Y-site administration. Triplicate test samples were prepared by admixing 7.5 mL of palonosetron hydrochloride with 7.5 mL of the fluorouracil and gemcitabine hydrochloride admixtures. Physical stability was assessed by using a multistep evaluation procedure that included both turbidimetric and particulate measurements as well as visual inspection. Chemical stability was assessed by using stability-indicating high-performance liquid chromatographic analytical techniques that determined drug concentrations. Evaluations were performed initially upon mixing and 1 and 4 hours after mixing. The samples were clear and colorless when viewed in normal fluorescent room light and when viewed with a Tyndall beam. Measured turbidity remained unchanged; particulate cont

Related Keywords: Yanping Zhang, BS, stability, Lawrence A. Trissel, BS, RPh, FASHP, palonosetron hydrochloride, gemcitabine hydrochloride, chemotherapy agents, fluorouracil


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