Abstract

Physical and Chemical Stability of Palonosetron Hydrochloride with Glycopyrrolate and Neostigmine During Simulated Y-Site Administration

Author(s): Ben Michel, Trusley Craig, Kupiec Thomas C, Trissel Lawrence A

Issue: Jul/Aug 2008 - Hormone Replacement Therapy

Page(s): 368-371

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Abstract

The objective of this study was to evaluate the physical and chemical stability of undiluted palonosetron hydrochloride 50 mcg/mL when mixed with undiluted glycopyrrolate 0.2 mg/mL and neostigmine methylsulfate 0.5 mg/mL during simulated Y-site administration. Duplicate test samples were prepared by admixing 7.5 mL of palonosetron hydrochloride with 7.5 mL of glycopyrrolate and neostigmine methylsulfate injections. Physical stability was assessed by using a multi-step evaluation procedure that included both turbidimetric and particulate measurements and visual inspection. Chemical stability was assessed by using stability-indicating high-performance liquid chromatography analytical techniques based on the determination of 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 and particulate content was low a

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