Analysis of Fructose Glucose Syrup According to Japanese Pharmaceutical Excipients Method (KS-801)

According to Japanese Pharmaceutical Excipients 2018 (Notification from the Ministry of Health, Labour and Welfare: March 28, 2024*), “Assay" and "(8) Related substances" for “Fructose Glucose Syrup" should be carried out with a column filled with strong acidic ion-exchange resin. The SUGAR KS-801 confirmed the requirements were met.

System suitability requirementsElution order (Standard solution): glucose, fructose
Resolution between glucose and fructose (Standard solution): ≥ 1.5
Relative standard deviation (RSD) of the peak areas of glucose and fructose (Standard solution): ≤ 1.0% each (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 10 µL
(Standard solution) 84 mg/mL of Fructose and 60 mg/mL of Glucose in H2O

  1. 1.Glucose
  2. 2.Fructose
Chromatogram of Glucose and Fructose
Column
Shodex SUGAR KS-801 (8.0 mm I.D. x 300 mm)
Eluent
H2O
Flow rate
0.6 mL/min
Detector
RI
Column temp.
80 ℃

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