Stability of 25 mg/mL azacitidine suspensions stored in polypropylene syringes at -20*C

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Stability of 25 mg/mL azacitidine suspensions stored in polypropylene syringes at -20ºC

J. Vigneron, A. Duriez, H. Zenier, I. May, B. Demoré
University Hospital Brabois, Pharmacy, Vandoeuvre, France

Background: The manufacturer of azacitidine (Vidaza®) indicates a stability of 45
minutes at room temperature and 8 hours at 2-8°C.The aim of this study was to look for a longer period of stability.

Purpose: We investigated how freezing at -20°C affects the stability of azacitidine suspension 25 mg/mL in polypropylene syringes. This could allow to prepare suspensions in advance.

Material and methods: Azacitidine was manipulated under aseptic conditions:
reconstitution with sterile water for injection and preparation of syringes. The stability was studied after freezing for 8 days at - 20°C, defrosting at room temperature and storage for 8 hours at 2-8°C. Samples were analysed by a stability-indicating highperformance liquid chromatographic method using a reversedphase
column, a mobile phase consisting of phosphate buffer 10 mM pH 6,5, and detection wavelenght at 200 nm. Visual inspection was also performed.

Results: No modification of suspension or coloration was visually observed in any syringes. Azacitidine concentrations we degradation products were observed at the beginning of the study. They represented approximately 5 % of the total of the peaks surfaces. At the end of the study, only one degradation product has slightly increased and no other degradation products appeared after 8 days of freezing.

Conclusion: Azacitidine suspension 25 mg/mL was stable for 8 days at -20°C. After thawing at room temperature, suspension was stable for 8 hours at 2-8°C. Azacitidine syringes can be prepared in advance.

Reference: Poster in: 16th Congress of EAHP. 30 March-01 April 2011, Vienna, Austria