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

According to Japanese Pharmaceutical Excipients 2018 method (PSB Notification No. 0328-1 by the Pharmaceutical Safety Bureau, MHLW, dated March 28, 2024 (New instructions)), the assay for fructose glucose syrup (high fructose syrup) is carried out with a column filled with strong acid ion-exchange resin and meets following requirements. The use of SUGAR KS-801 column confirmed the requirements were met.

 

System suitability requirements

Resolution between fructose and glucose for a 10-µL injection of the standard solution: ≥ 1.5
Relative standard deviation of each fructose and glucose peak area for the six repeated analysis: ≤ 1.0

*The version at the time of the application acquisition.

Sample: 10 μL
(Standard solution)

  1. 1.Glucose 60 mg/mL
  2. 2.Fructose 84 mg/mL
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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