Physicochemical stability of Gemcitabine Accord 100 mg/mL in punctured original vials and after dilution with 0.9% sodium chloride in polyolefine bags

Study objectives: To determine the physicochemical stability of Gemcitabine Accord 100 mg/mL concentrate in original vials after first opening and after dilution with 0.9% sodium chloride solution in polyolefine (PO) bags at concentrations of 0.1 mg/mL and 10 mg/mL. Methods: Test solutions were aseptically prepared with Gemcitabine Accord 100 mg/mL and stored without protection from light at room temperature for up to 84 days. Samples were taken and analysed initially and at predetermined time points. Analyses comprised pH measurement, visual inspection and high-performance liquid chromatography (HPLC) assay. Results: Gemcitabine Accord 100 mg/mL concentrate in punctured vials remained physicochemically stable for 28 days when stored at room temperature without light protection. Gemcitabine diluted with 0.9% sodium chloride solution and stored in PO bags at room temperature under ambient light conditions remained physicochemically stable over the observation period of 84 days, irrespective of the gemcitabine concentration (0.1 mg/mL, 10 mg/mL). Conclusion: Gemcitabine Accord 100 mg/mL remaining solution in punctured vials can be used for up to 28 days when stored at room temperature without light protection. Diluted gemcitabine solutions in the concentration range of 0.1 mg/mL to 10 mg/mL can be prepared in advance and used over a period of 84 days, when stored in PO bags at room temperature. Keywords: concentrated solution, diluted infusion solution, gemcitabine, physicochemical stability