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Stability of Furosemide 5 mg/mL in Polypropylene Syringes.

J A J van der Schaar1, R Grouls2, E J F Franssen1

  • 1Department of Pharmacy, OLVG Hospital, Amsterdam, The Netherlands.

International Journal of Pharmaceutical Compounding
|September 13, 2019
PubMed
Summary

Ready-to-administer furosemide solutions in transparent syringes are stable for 35 days refrigerated and 24 hours at room temperature. This stability supports extended storage and continuous infusion without light protection.

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Area of Science:

  • Pharmaceutical Science
  • Drug Stability Studies
  • Clinical Pharmacy

Background:

  • Furosemide parenteral solutions are essential in hospital settings.
  • The stability of furosemide in transparent syringes is not well-documented.
  • Assessing stability is crucial for safe and effective medication administration.

Purpose of the Study:

  • To evaluate the stability of furosemide 5-mg/mL in transparent polypropylene syringes.
  • To determine the impact of storage conditions (refrigeration, room temperature, light exposure) on furosemide stability.
  • To assess the physical, chemical, and microbiological integrity of the solutions.

Main Methods:

  • Furosemide 5-mg/mL solutions were prepared in 8-mL and 50-mL transparent polypropylene syringes.
  • High-performance liquid chromatography (HPLC) was used to quantify furosemide concentration over 35 days at 4°C (protected from light) and 24 hours at 20°C (exposed to daylight).
  • Visual inspection for appearance, pH measurements, and microbiological assays were conducted.

Main Results:

  • Furosemide solutions maintained clarity, color, and absence of particles throughout the study.
  • No significant changes in pH were observed.
  • Furosemide concentrations remained within the acceptable range (95%-105%) under tested conditions.
  • No bacterial or fungal growth was detected in microbiological assays.

Conclusions:

  • Ready-to-administer furosemide 5-mg/mL in 8-mL and 50-mL polypropylene syringes is stable for up to 35 days when refrigerated (4°C, protected from light).
  • The solutions are also stable for 24 hours at room temperature (20°C, exposed to daylight).
  • These findings support extended storage and 24-hour continuous infusion at ambient temperature without light protection.