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 Carboplatin Accord 10 mg/mL in punctured original vials and polypropylene (PP) syringes as well as after dilution with commonly used infusion fluids in polyethylene (PE) bottles at two different concentrations (0.3 mg/mL, 3.0 mg/mL).
Methods: Test solutions were prepared aseptically and stored at 20°C‒25°C and normal room light for 14 days (undiluted test solutions) or 84 days (diluted test solutions). 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 carboplatin in punctured vials and PP syringes was given for 14 days at 20°C‒25°C. After dilution with 5% glucose solution carboplatin test solutions in PE bottles remained physicochemical stable at room temperature for 42 days (0.3 mg/mL) and 63 days (3.0 mg/mL), respectively. After dilution with 0.9% sodium chloride solution, carboplatin concentrations declined rapidly.
Conclusion: Residues of Carboplatin Accord 10 mg/mL in punctured original glass vials as well as in PP syringes can be used cost-effectively for up to 14 days when stored at 20°C‒25°C and normal room light. Infusion solutions diluted with 5% glucose solution can be prepared in advance and used over a period of 42 days (0.3 mg/mL) and 63 days (3.0 mg/mL) when stored at 20°C‒25°C and normal room light. The dilution of carboplatin in 0.9% sodium chloride infusion solution is not recommended due to the increased rates of carboplatin degradation.

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.