title: Stability of dexmedetomidine 4 μg/mL in polypropylene syringes.
abstract: OBJECTIVE
  The results of a study to determine the long-term (up to 14 days) stability of diluted dexmedetomidine kept in polypropylene syringes under typical pharmacy storage conditions are presented.
  
  
  METHODS
  Four samples of dexmedetomidine injection diluted to 4 μg/mL in 0.9% sodium chloride were prepared and divided into 25-mL portions for storage in syringes at ambient room temperature (20-25 °C) with light exposure or under refrigeration (5 °C) in darkness. At 24 and 48 hours, the percentage of the initial dexmedetomidine concentration remaining in all samples was assessed via high-performance liquid chromatography with diode-array detection; further stability testing of the refrigerated samples was performed on days 7 and 14. At each time point, the test samples were visually inspected for color, clarity, and signs of formation of particulate matter.
  
  
  RESULTS
  As determined by chromatographic analyses, the samples of diluted dexmedetomidine stored in syringes at room temperature exhibited a loss of drug concentration of <10% over 48 hours; the refrigerated samples exhibited a loss of drug concentration of <5% over 14 days. All of the syringe-stored samples remained clear and colorless on visual inspection for the duration of the study.
  
  
  CONCLUSIONS
  Dexmedetomidine diluted to 4 μg/mL in 0.9% sodium chloride injection was stable for at least 48 hours at 20-25 °C and 14 days at 5 °C when stored in polypropylene syringes.
authors.affiliation: Department of Pharmacy, Primary Children’s Medical Center, 100 Mario Capecchi Drive, Salt Lake City, UT 84113, USA. collin.anderson@imail.org
authors.forename: Collin R
authors.initials: CR
authors.lastname: Anderson
authors.forename: Mark W
authors.initials: MW
authors.lastname: MacKay
authors.forename: Marc
authors.initials: M
authors.lastname: Holley
authors.forename: Brent A
authors.initials: BA
authors.lastname: Kay
mesh_terms: D058647:Adrenergic alpha-2 Receptor Agonists / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid; D020927:Dexmedetomidine / Q000032:analysis / Q000737:chemistry*; D004355:Drug Stability; D011126:Polypropylenes; D013594:Syringes
chemical_list: D058647:Adrenergic alpha-2 Receptor Agonists; D011126:Polypropylenes; D020927:Dexmedetomidine