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 Doxorubicin Accord 2 mg/mL concentrate in original glass vials after first opening and after transfer to polypropylene (PP) syringes as well as diluted Doxorubicin Accord solutions (0.05 mg/mL, 1.6 mg/mL) in 0.9% sodium chloride or 5% glucose solution in polyolefine (PO) bottles stored at 2 °C‒8°C for up to 96 days.
Methods: Test solutions were aseptically prepared with Doxorubicin 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. Physicochemical stability was assessed via pH measurements, visual inspections and high-performance liquid chromatography (HPLC) assay.
Results: Doxorubicin Accord 2 mg/mL concentrate in original vials after first opening and in PP syringes remained physicochemically stable when stored light protected under refrigeration over the entire observation period of 28 days and 96 days, respectively. Diluted Doxorubicin Accord solutions stored light protected in PO bottles 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 (0.05 mg/mL, 1.6 mg/mL).
Conclusion: Residues of Doxorubicin Accord 2 mg/mL concentrate in punctured original vials or after transfer to PP syringes can be used for 28 days and 96 days, respectively, when stored at 2°C‒8°C. Doxorubicin Accord diluted with 0.9% sodium chloride solution or 5% glucose solution in PO-bottles (concentration range 0.05 mg/mL to 1.6 mg/mL) can be prepared in advance and used over a period of 84 days, when stored light protected 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.