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J Oncol Pharm Pract. 2017 Jan 01;1078155217732629. doi: 10.1177/1078155217732629. Epub 2017 Jan 01.

Long-term stability of ganciclovir in polypropylene containers at room temperature.

Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners

Nicolas Guichard, Pascal Bonnabry, Serge Rudaz, Sandrine Fleury-Souverain

Affiliations

  1. 1 Pharmacy, Geneva University Hospitals, Geneva, Switzerland.
  2. 2 School of Pharmaceutical Sciences, University of Geneva, University of Lausanne, Geneva, Switzerland.

PMID: 28975863 DOI: 10.1177/1078155217732629

Abstract

Purpose Ganciclovir is increasingly provided by hospital pharmacy production unit in a ready-to-use form, in order to improve the safety of healthcare workers and the efficiency of the organisation. The objective of this study was to develop a stability-indicating method to assay ganciclovir and determine the stability of ganciclovir in syringes (5 mg/mL) and infusion bags (0.25 and 5 mg/mL) at two different temperatures. Method Ganciclovir solutions (0.25 mg/mL and 5 mg/mL) in 0.9% sodium chloride were prepared in 50 mL polypropylene syringes or 100 mL polypropylene infusion bags and stored at 2-8℃ and 23-27℃. The chemical stability was measured using a stability-indicating Ultra High Performance Liquid Chromatography coupled to mass spectrometry method. Physical stability was assessed by visual inspection. Results No significant loss of ganciclovir under any of the tested conditions was observed in this study. All solutions remained clear through the study period. Conclusion All tested formulations remained stable for at least 185 days independently of container type, temperature or concentration studied.

Keywords: Antineoplastic agents; ganciclovir; stability; storage; temperature

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