Cytarabine in polypropylene syringes stable at 2–8 °C for 28 days
The physical and chemical stability of cytarabine diluted in 0.9% NaCl in polypropylene syringes is at its highest at 2–8 °C, a recent study in Tunisia has found. The 1-mg/mL solution demonstrates better stability at 25 °C relative to those at higher concentrations (5 and 10 mg/mL).
The investigators confirmed the capacity of the stability-indicating high-performance liquid chromatography method applied in this study. All tested cytarabine solutions (1, 5, and 10 mg/mL) at 2–8 °C were chemically stable for 28 days.
At 25 °C, however, the main degradation product slowly increased, and the 1-, 5-, and 10-mg/mL solutions were chemically stable for 14, 8, and 5 days, respectively. In addition, results observed in the glass containers were comparable.
In this study, cytarabine solutions in 0.9% NaCl were prepared in polypropylene syringes and stored for 28 days under different conditions. As a control, cytarabine solutions were also prepared in glass containers to detect any adsorption.
The investigators assessed chemical stability using a stability-indicating high-performance liquid chromatography method and proved the capacity of such method through forced degradation tests. They also performed linearity, precision, and limit of detection and quantification according to the International Conference on Harmonisation recommendations. Finally, visual inspection was carried out to check physical stability.
“Cytarabine is widely used to treat leukaemia and lymphoma,” the investigators said. “Currently, Cyrabol, powder for injection, is one of the specialties marketed in Tunisia.”