title: Stability of fentanyl 5 microg/mL diluted with 0.9% sodium chloride injection and stored in polypropylene syringes.
abstract: OBJECTIVE
  The stability of fentanyl 5 microg/mL in 0.9% sodium chloride solution packaged in polypropylene syringes was studied.
  
  
  METHODS
  Samples of fentanyl 5 microg (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 degrees 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.
  
  
  CONCLUSIONS
  Fentanyl 5 microg (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.
authors.affiliation: Mayo Clinic Rochester, Rochester, MN 55902, USA. mccluskey.susan@mayo.edu
authors.forename: Susan V
authors.initials: SV
authors.lastname: McCluskey
authors.forename: Kevin K
authors.initials: KK
authors.lastname: Graner
authors.forename: Jesse
authors.initials: J
authors.lastname: Kemp
authors.forename: Vasileios
authors.initials: V
authors.lastname: Aloumanis
authors.forename: Michel
authors.initials: M
authors.lastname: Ben
authors.forename: Thomas
authors.initials: T
authors.lastname: Kupiec
authors.forename: Nicole
authors.initials: N
authors.lastname: Vu
mesh_terms: D004355:Drug Stability; D005283:Fentanyl / Q000008:administration & dosage / Q000737:chemistry*; D019999:Pharmaceutical Solutions / Q000008:administration & dosage / Q000737:chemistry; D011126:Polypropylenes / Q000592:standards; D012965:Sodium Chloride / Q000008:administration & dosage / Q000737:chemistry*; D013594:Syringes / Q000592:standards
chemical_list: D019999:Pharmaceutical Solutions; D011126:Polypropylenes; D012965:Sodium Chloride; D005283:Fentanyl