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 Etoposide Accord concentrate in punctured vials and after dilution to the concentrations 0.2 mg/mL, 0.4 mg/mL and 0.45 mg/mL in commonly used infusion fluids and containers.
Methods: Test solutions were prepared aseptically and stored under normal light conditions at room temperature or light protected under refrigeration for up to 28 days. Initially and at predetermined time points, physical stability was assessed by visual inspection and chemical stability was determined by a validated, stability indicating high-performance liquid chromatography (HPLC) method.
Results: Physicochemical stability of etoposide in punctured vials was given for 28 days when stored at room temperature. Diluted etoposide infusion solutions 0.2 mg/mL remained stable for 28 days, independent of storage temperatures and infusion fluid. Physical stability of etoposide infusion solutions 0.4 mg/mL and 0.45 mg/mL was limited. Storage under refrigeration resulted in precipitation. When stored at room temperature etoposide solutions of the concentration 0.4 mg/mL revealed to be physicochemically stable for 48 hours in non-PVC bags and 24 hours in polypropylene syringes (in 0.9% sodium chloride and 5% glucose solution) and for 28 days in polyolefine bags (in 0.9% sodium chloride solution only).
Conclusion: Residues in the punctured Etoposide Accord original glass vials can be used cost-effectively for up to 28 days when stored at room temperature. Diluted infusion solutions with etoposide concentrations up to 0.2 mg/mL can be prepared in advance and used over a period of 28 days. Etoposide infusion solutions with concentrations between 0.4 mg/mL to 0.45 mg/mL should be stored at room temperature for a maximum of 96 hours. Prior to administration solutions must be inspected for precipitation.

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.