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 undiluted Cisplatin Accord 1 mg/mL in punctured original vials and polypropylene (PP) syringes as well as after dilution with 0.9% sodium chloride solution in polyethylene (PE) bottles at two different concentrations (0.01 mg/mL, 0.4 mg/mL).
Methods: Test solutions were prepared aseptically and stored at 20°C–25°C without light protection for up to 96 days. At predetermined time points physical stability was assessed by visual inspection and pH measurement. Chemical stability was determined by a validated, stability indicating high-performance liquid chromatography (HPLC) method.
Results: Physicochemical stability of Cisplatin Accord 1 mg/mL was established for 14 days in punctured original vials and 30 days in PP syringes when stored at 20°C–25°C. After dilution with 0.9% sodium chloride solution in PE bottles and storage at 20°C–25°C for 35 days, loss of cisplatin concentrations amounted to 5.5% (initial concentration 0.01 mg/mL) and 7.7% (0.4 mg/mL), respectively.
Conclusion: Residues of Cisplatin Accord 1 mg/mL in punctured original glass vials or transferred to PP syringes can be used cost-effectively when stored at 20°C–25°C up to 14 days or 30 days, respectively. Infusion solutions diluted with 0.9% sodium chloride solution can be prepared in advance and used over a period of 35 days when stored at 20°C–25°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.