eISSN: 1897-4309
ISSN: 1428-2526
Contemporary Oncology/Współczesna Onkologia
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vol. 16
Original paper

The physical and chemical stability of cisplatin (Teva) in concentrate and diluted in sodium chloride 0.9%

Agnieszka Karbownik, Edyta Szałek, Hanna Urjasz, Aleksandra Głęboka, Emilia Mierzwa, Edmund Grześkowiak

Wspolczesna Onkol 2012; 16 (5): 435–439
Online publish date: 2012/11/20
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Aim of the study: The subject of study was the stability of cisplatin in concentrate in glass vials and diluted in polyethylene (PE) bags stored at 15–25°C for up to 30 days.

Material and methods: Original vials of cisplatin injection (1 mg/ml, Teva) were stored at room temperature and subjected to re-piercing after 1, 2, 3, 7, 14, 21, 28 and 30 days following the initial piercing. Cisplatin infusions at nominal concentrations of 0.1 mg/ml were prepared in 0.9% sodium chloride (1000 ml) in PE bags. Chemical stability was measured by means of a stability-indicating high-performance liquid chromatography (HPLC) assay. Physical stability was assessed by visual inspection in normal light.

Results: The concentration of cisplatin at each sampling time in the analysed solutions remained within 92.0–100.7% of initial concentration, regardless of the container. No changes in colour or turbidity were observed in any of the vials or prepared solutions.

Conclusions: Cisplatin, both undiluted in glass containers and diluted with NaCl 0.9% in PE bags, remains stable (< 10% degradation) for at least 30 days at room temperature when protected from light.

cisplatin, stability, concentrate, infusion


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