Analysis of Hydrogenated Maltose Starch Syrup According to Japanese Pharmaceutical Excipients (KS-801)

According to Japanese Pharmaceutical Excipients 2013*, “Assay" for “Hydrogenated Maltose Starch Syrup" should be carried out with a column filled with strong acidic ion-exchange resin consist of polystyrene modified with sulfonic acid groups. The SUGAR KS-801 confirmed the requirements were met.

Selection of columnElution order (Standard solution): maltitol, the internal standard (propylene glycol)
Resolution between maltitol and the internal standard (Standard solution): ≥ 1.5

*The version at the time of the application acquisition.

Sample: 10 µL
(Standard solution) 10 mg/mL each of Maltitol and Propylene glycol in H2O

  1. 1.Maltitol
  2. 2.Propylene glycol
Column
Shodex SUGAR KS-801 (8.0 mm I.D. x 300 mm))
Eluent
H2O
Flow rate
0.37 mL/min
Detector
RI
Column temp.
50 ℃

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