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Chemical Stability of Fentanyl in Polypropylene Syringes and Polyvinylchloride Bags

Author(s):  Donnelly Ronald F

Issue:  Nov/Dec 2005 - Pediatrics
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Abstract:  Fentanyl is a potent synthetic lipophilic opiate agonist used to control pain as a single agent or in combination with local anesthetics. The chemical stability of the undiluted commercial solution (50 µg/mL) in polypropylene syringes or polyvinylchloride bags has never been reported. Undiluted fentanyl solution, 50 µg/mL, was aseptically transferred to polypropylene syringes or polyvinylchloride bags. Samples were then stored, either at 5°C and protected from light, or at 22°C and exposed to light, for 28 days. A stability-indicating high-performance liquid chromatographic method was used to monitor the fentanyl concentration of the samples. Color, clarity, and pH also were monitored. After storage for 28 days, there were no signs of chemical degradation of fentanyl packaged in either polypropylene syringes or polyvinyl chloride bags at either 5°C or 22°C. All solutions remained colorless and clear over the course of the study. The pH did not change significantly after storage for 28 days. Fentanyl solutions, when packaged undiluted in polypropylene syringes or polyvinylchloride bags, are chemically stable for 28 days when stored either at 5°C and protected from light or at 22°C and exposed to light.

Related Keywords: Ronald F. Donnelly, MSc (Chem), BSc (Pharm), fentanyl, opioid, pain management, pain relief, pain control, analgesia, analgesic, stability, polypropylene syringes, polyvinylchloride bags, PVC


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