“The stability of ertapenem solution in syringes at room, refrigerator, and freezer temperatures was determined to establish options for extended storage.” Janin et al (2014).
Jain, J.G., Sutherland, C., Nicolau, D.P. and Kuti, J.L. (2014) Stability of ertapenem 100 mg/mL in polypropylene syringes stored at 25, 4, and −20 °C. American Journal of Health-System Pharmacy. 71(17), p.1480-1484.
Purpose: The stability of ertapenem solution in syringes at room, refrigerator, and freezer temperatures was determined to establish options for extended storage.
Methods: Six replicate solutions of ertapenem (100 mg/mL) in 0.9% sodium chloride injection were prepared in 20-mL polypropylene syringes and stored at 25, 4, or −20 °C. Syringe samples were collected immediately after preparation and at preselected time points and assayed by a validated high-performance liquid chromatography (HPLC) method. The ertapenem solution was considered stable if at least 90% of the mean initial concentration remained at the time of HPLC analysis.
Results: The mean ± S.D. baseline ertapenem concentration across all stability studies was 109.9 ± 9.2 mg/mL. One hour after preparation, the mean ± S.D. ertapenem concentration of samples kept at room temperature was 87.8 ± 4.6% of the initial concentration. After 24 and 48 hours of refrigeration, mean ± S.D. drug concentrations had declined to 93.6 ± 5.9% and 86.2 ± 4.3% of the respective baseline concentrations. Frozen syringes required 1 hour to thaw at room temperature; after 14 and 28 days of frozen storage, the mean ± S.D. ertapenem concentrations of these samples 4 hours after thawing were 93.4 ± 3.5% and 86.4 ± 2.6% of the respective baseline values.
Conclusion: Ertapenem 100 mg/mL prepared in 20-mL polypropylene syringes was stable at room temperature for approximately 30 minutes. Room-temperature stability was extended to 4 hours after 24 hours of refrigeration. After being frozen for 14 or 28 days, ertapenem was stable for 3–5 hours after removal from the freezer.
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