Author byline as per print journal: Professor Irene Krämer, PhD; Frank Erdnuess, PhD; Judith Thiesen, PhD, Germany

Study objectives: To determine the physicochemical stability of Cytarabine Accord 100 mg/mL in punctured original vials and after dilution with 0.9% sodium chloride solution in polyolefine (PO) bags stored at room temperature.
Methods: Cytarabine Accord 100 mg/mL was diluted with 0.9% sodium chloride solution in PO bags to nominal cytarabine concentrations 0.19 mg/mL and 7.6 mg/mL. Test solutions were stored at 20°C‒25°C without light protection for up to 84 days. Samples were taken and analysed immediately after dilution (Day 0) and at predetermined time points. Stability analysis comprised pH measurements, visual inspections and high-performance liquid chromatography (HPLC) assays.
Results: Physicochemical stability of Cytarabine Accord 100 mg/mL in punctured vials and of diluted cytarabine test solutions in PO bags (0.19 mg/mL, 7.6 mg/mL) in 0.9% sodium chloride solution was established for 84 days.
Conclusion: Residues of Cytarabine Accord 100 mg/mL concentrate stored at room temperature, without light protection can be used after first opening for up to 84 days. Cytarabine solutions diluted with 0.9% sodium chloride solution in PO bags can be prepared in advance by pharmacy-based cytotoxic units and used over a period of 84 days.

Submitted: 4 March 2024; Revised: 15 April 2024; Accepted: 26 April 2024; Published online first: 6 May 2024

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This manuscript has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record.