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Long-term stability study of clofarabine injection concentrate and diluted clofarabine infusion solutions

2011

Purpose: The aim of this study was to investigate the physicochemical stability of clofarabine (CAFdA) injection concentrate and ready-to-use CAFdA infusion solutions over a prolonged period of 28 days. Methods: To determine the stability of CAFdA infusion solutions, the injection concentrate (Evoltra®, 1 mg/mL, Genzyme) was diluted either with 0.9% sodium chloride or 5% glucose infusion solution. The resulting concentrations of 0.2 mg/mL or 0.6 mg/mL, respectively, were chosen to represent the lower and upper limit of the ordinary concentration range. Test solutions were stored under refrigeration (2–8°C) or at room temperature either light protected or exposed to light. CAFdA concentrati…

Time FactorsStability studyDrug StorageSodiumchemistry.chemical_elementAntineoplastic AgentsInjection concentratechemistry.chemical_compoundGlucose infusionDrug StabilitymedicineClofarabinePharmacology (medical)Clofarabine InjectionInfusions IntravenousChromatography High Pressure LiquidChromatographyAdenine Nucleotidesbusiness.industryReproducibility of ResultsPolyethylenePharmaceutical SolutionsPolyvinyl chlorideOncologychemistryArabinonucleosidesbusinessClofarabinemedicine.drugJournal of Oncology Pharmacy Practice
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