Levels of 5-hydroxymethylfurfural in dextrose injection

Area of Science:

• Analytical Chemistry
• Pharmaceutical Science

Background:

• 5-hydroxymethylfurfural (5-HMF) is a degradation product found in dextrose solutions.
• Monitoring 5-HMF levels is crucial for ensuring the quality and safety of intravenous dextrose injections.

Purpose of the Study:

• To determine the levels of 5-HMF in Dextrose Injection USP.
• To investigate the impact of storage duration and temperature on 5-HMF accumulation.
• To propose the establishment of limits for 5-HMF in commercial dextrose solutions.

Main Methods:

• Spectrophotometry was employed to quantify 5-HMF concentrations.
• Analysis was performed on freshly prepared dextrose solutions and aged 50% dextrose injections.
• Data for 10% fructose injection were also reported.

Main Results:

• A freshly prepared dextrose solution exhibited a 5-HMF level of 0.10 µg/ml.
• 50% dextrose injection showed 0.72 µg/ml of 5-HMF within 24 hours of manufacturing.
• After four years of storage at 70°F, 5-HMF levels in 50% dextrose injection rose to 5.80 µg/ml.

Conclusions:

• 5-HMF levels in dextrose injections increase significantly over time and with storage.
• Quantitative procedures for 5-HMF determination should be integrated into the quality control of dextrose injections.
• Establishing regulatory limits for 5-HMF in commercially available dextrose solutions is feasible and recommended.