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American Journal of Health-System Pharmacy, Vol. 66, Issue 9, 860-863
Copyright © 2009. American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/04/0602-1242$06.00

Note

Stability of fentanyl 5 µg/mL diluted with 0.9% sodium chloride injection and stored in polypropylene syringes

 Susan V. McCluskey, Kevin K. Graner, Jesse Kemp, Vasileios Aloumanis, Michel Ben, Thomas Kupiec and Nicole Vu

SUSAN V. MCCLUSKEY, B.S.PHARM., is Pharmacy Production Laboratory Pharmacist; and KEVIN K. GRANER, B.S.PHARM., is Pediatric Pharmacy Services Supervisor, Mayo Clinic Rochester, Rochester, MN. JESSE KEMP, M.S.F.S., is Forensic Research Analyst; VASILEIOS ALOUMANIS, M.S.F.S., is Chemist III; MICHEL BEN, M.S., is Laboratory Supervisor; THOMAS KUPIEC, PH.D., is Director of Laboratories; and NICOLE VU, Ph.D., is Scientific Director, Analytical Research Laboratories, Oklahoma City, OK.

Address correspondence to Ms. McCluskey at the Mayo Clinic Rochester, 201 West Center Street, Ei 1-420 Pharmacy Services, Rochester, MN 55902 (mccluskey.susan{at}mayo.edu).


Purpose. The stability of fentanyl 5 µg/mL in 0.9% sodium chloride solution packaged in polypropylene syringes was studied.

Methods. Samples of fentanyl 5 µg (as the citrate) per milliliter in 0.9% sodium chloride injection were prepared and assessed for chemical stability using a validated, stability-indicating high- performance liquid chromatographic (HPLC) assay. A total of 12 syringe samples were submitted for chemical stability testing by HPLC. The syringes were protected from light and stored in controlled ambient conditions (23–27 °C and 55–65% relative humidity) in an environmental chamber. Three samples were tested initially and at each 30-day interval. Each syringe sample was tested with two determinations, using the average of the determinations for the assay result. Samples were assessed for pH and inspected for color and visible particulate matter. Stability was defined as the retention of 90–110% of the initial drug concentration at 30, 60, and 90 days.

Results. Fentanyl citrate injection maintained the appearance of a clear, colorless solution, with mean ± S.D. pH values ranging from 4.13 ± 0.01 to 4.52 ± 0.02 throughout the study period. Recovery of fentanyl ranged from 99.86% ± 0.29% to 102.74% ± 1.60% of the initial concentration, with no detectable changes in the chromatographic profiles of all tested samples.

Conclusion. Fentanyl 5 µg (as the citrate) per milliliter in 0.9% sodium chloride injection, packaged in polypropylene syringes and stored protected from light, was stable for at least 90 days in controlled ambient conditions.

Index terms: Chromatography, liquid; Color; Concentration; Diluents; Fentanyl citrate; Hydrogen ion concentration; Injections; Opiates; Polymers; Polypropylene; Sodium; Stability; Storage; Syringes

 

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