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 Epirubicin Accord 2 mg/mL concentrate in original glass vials after first opening and after transfer to polypropylene (PP) syringes as well as diluted Epirubicin Accord solutions 0.1 mg/mL, 1.6 mg/mL in 0.9% sodium chloride solution or 5% glucose solution in polyolefine (PO) bags stored at 2°C–8°C for up to 96 days or 84 days.
Methods: Test solutions were aseptically prepared with Epirubicin Accord 2 mg/mL and stored light protected at 2°C–8°C. Samples were taken and analysed initially (Day 0) and at predetermined time points. Analysis comprised pH measurements, visual inspections and high-performance liquid chromatography (HPLC) assays.
Results: Epirubicin Accord 2 mg/mL concentrate in original vials after first opening and in PP syringes remained physicochemically stable when stored refrigerated under light protection over the observation period of 96 days. Diluted epirubicin solutions stored light protected in PO bags at 2°C–8°C remained physicochemically stable over the observation period of 84 days, irrespective of vehicle solution (0.9% sodium chloride, 5% glucose solution) and concentration (0.1 mg/mL, 1.6 mg/mL).
Conclusion: Residues of Epirubicin Accord 2 mg/mL concentrate in punctured original vials or transferred to PP syringes can be used for up to 96 days when stored at 2°C–8°C. Epirubicin Accord diluted with 0.9% sodium chloride solution or 5% glucose solution in the concentration range 0.1 mg/mL to 1.6 mg/mL can be prepared in advance and used over a period of 84 days, when stored in PO bags and refrigerated at 2°C–8°C.

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.