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 Docetaxel Accord infusion solutions 0.3 mg/mL and 0.9 mg/mL in non-PVC-bags either pre-filled with 0.9% sodium chloride solution or 5% glucose solution for up to 98 days.
Methods: Docetaxel Accord 20 mg/mL was diluted with 0.9% sodium chloride solution or 5% glucose solution in non-PVC bags to achieve final docetaxel concentrations of 0.3 mg/mL and 0. 9 mg/mL. Test solutions were stored at room temperature for a maximum period of 24 hours and refrigerated for maximum 98 days. Samples were taken and analysed at predetermined time points. Analysis comprised pH measurements, visual inspections, and high-performance liquid chromatography (HPLC) analysis.
Results: Diluted docetaxel solutions in non-PVC bags stored at room temperature and under refrigeration remained physicochemically stable over the observation period of 24 hours and 98 days, respectively. Results were irrespective of diluent (0.9% sodium chloride, 5% glucose) and concentration (0.3 mg/mL, 0.9 mg/mL).
Conclusion: Diluted Docetaxel Accord solutions in non-PVC bags can be prepared in advance and used over a period of 24 hours when stored at room temperature and 98 days when stored 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.