Murty B S, Kapoor J N, Smith F X
Am J Hosp Pharm. 1977 Feb;34(2):205-6.
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.
采用分光光度法测定了美国药典葡萄糖注射液中降解产物5-羟甲基糠醛（5-HMF）的含量。新配制的葡萄糖溶液（1 g/2 ml）中5-HMF含量为0.10 μg/ml。50%葡萄糖注射液在生产后24小时内的含量为0.72 μg/ml。50%葡萄糖注射液在70°F下储存四年后的5-HMF含量为5.80 μg/ml。还报告了10%果糖注射液的数据。结论是可以确定市售溶液中5-HMF含量的限度。建议在葡萄糖注射液的质量控制检测中纳入测定该杂质的定量方法。
