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Walker SE, Law S, Perks W, et al. Stability of Ertapenem 100 mg/mL in Manufacturer's Glass Vials or Syringes at 4°C and 23°C. Can J Hosp Pharm. 2015;68(2):121-6doi: 10.4212/cjhp.v68i2.1437.
Walker, S. E., Law, S., Perks, W., & Iazzetta, J. (2015). Stability of Ertapenem 100 mg/mL in Manufacturer's Glass Vials or Syringes at 4°C and 23°C. The Canadian journal of hospital pharmacy, 68(2), 121-6. https://doi.org/10.4212/cjhp.v68i2.1437
Walker, Scott E, et al. "Stability of Ertapenem 100 mg/mL in Manufacturer's Glass Vials or Syringes at 4°C and 23°C." The Canadian journal of hospital pharmacy vol. 68,2 (2015): 121-6. doi: https://doi.org/10.4212/cjhp.v68i2.1437
Walker SE, Law S, Perks W, Iazzetta J. Stability of Ertapenem 100 mg/mL in Manufacturer's Glass Vials or Syringes at 4°C and 23°C. Can J Hosp Pharm. 2015 Mar-Apr;68(2):121-6. doi: 10.4212/cjhp.v68i2.1437. PMID: 25964683; PMCID: PMC4414073.
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Can J Hosp Pharm. 2015 Mar-Apr;68(2):121-6. doi: 10.4212/cjhp.v68i2.1437.

Stability of Ertapenem 100 mg/mL in Manufacturer's Glass Vials or Syringes at 4°C and 23°C.

The Canadian journal of hospital pharmacy

Scott E Walker, Shirley Law, William Perks, John Iazzetta

Affiliations

  1. MScPhm, is Director of Pharmacy, Sunnybrook Health Sciences Centre, and Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario.
  2. DipPharmTech, is a Research Assistant in Quality Control, Department of Pharmacy, Sunnybrook Health Sciences Centre, Toronto, Ontario.
  3. BScPhm, is Manager of Pharmacy Manufacturing, Sunnybrook Health Sciences Centre, Toronto, Ontario.
  4. 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.

PMID: 25964683 PMCID: PMC4414073 DOI: 10.4212/cjhp.v68i2.1437

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.

Keywords: ertapenem; high-performance liquid chromatography; polypropylene syringes; stability

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