Levels of 5-hydroxymethylfurfural in dextrose injection.

The levels of the degradation product, 5-hydroxymethylfurfural (5-HMF), in Dextrose Injection USP were determined by spectrophotometry. A freshly prepared solution of dextrose (1 g/2 ml) had a 5-HMF level of 0.10 mug/ml. The level in 50% dextrose injection, within 24 hours of manufacturing, was 0.72 mug/ml. The level of 5-HMF in 50% dextrose injection, after storage for four years at 70 F, was 5.80 mug/ml. Data are reported also for 10% fructose injection. It is concluded that limits for 5-HMF levels in commercially available solutions can be established. It is recommended that a quantitative procedure for determining this impurity be included in quality control testing of dextrose injection.