title: Stability of Ertapenem 100 mg/mL in Manufacturer's Glass Vials or Syringes at 4°C and 23°C.
abstract: BACKGROUND
  Prophylactic administration of ertapenem as a single 1-g IV dose has been shown to reduce sepsis after prostate biopsy.
  
  
  OBJECTIVE
  To evaluate the stability of ertapenem after reconstitution with 0.9% sodium chloride to a final concentration of 100 mg/mL and storage in the manufacturer's original glass vials or polypropylene syringes.
  
  
  METHODS
  On study day 0, 100 mg/mL solutions of ertapenem were retained in the manufacturer's glass vials or packaged in polypropylene syringes and stored at 4°C or 23°C without protection from fluorescent room light. Samples were assayed periodically over 18 days using a validated, stability-indicating liquid chromatographic method with ultra-violet detection. A beyond-use date was determined as the time for the concentration to decline to 90% of the initial (day 0) concentration, based on the fastest degradation rate, with 95% confidence.
  
  
  RESULTS
  Reconstituted solutions stored in the manufacturer's glass vials or polypropylene syringes exhibited a first-order degradation rate, such that 10% of the initial concentration was lost in the first 2.5 days when stored at 4°C or within the first 6.75 h when stored at room temperature (23°C). Analysis of variance showed differences in the percentage remaining due to temperature (p < 0.001) and study day (p < 0.001) but not type of container (p = 0.98). When a 95% CI for the degradation rate was calculated and used to determine a beyond-use date, it was established that more than 90% of the initial concentration would remain for 2.35 days at 4°C and for 0.23 day (about 5 h, 30 min) at room temperature.
  
  
  CONCLUSIONS
  A 100 mg/mL ertapenem solution stored in the manufacturer's glass vial or a polypropylene syringe will retain more than 90.5% of the initial concentration when stored for 48 h at 4°C and for an additional 1 h at 23°C.
authors.affiliation: MScPhm, is Director of Pharmacy, Sunnybrook Health Sciences Centre, and Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario.
authors.forename: Scott E
authors.initials: SE
authors.lastname: Walker
authors.affiliation: DipPharmTech, is a Research Assistant in Quality Control, Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Ontario.
authors.forename: Shirley
authors.initials: S
authors.lastname: Law
authors.affiliation: BScPhm, is Manager of Pharmacy Manufacturing, Sunnybrook Health Sciences Centre, Toronto, Ontario.
authors.forename: William
authors.initials: W
authors.lastname: Perks
authors.affiliation: PharmD, is Coordinator, Drug Information, Department of Pharmacy, Sunnybrook Health Sciences Centre, and Assistant Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario.
authors.forename: John
authors.initials: J
authors.lastname: Iazzetta
keywords: ertapenem; high-performance liquid chromatography; polypropylene syringes; stability