According to the Japanese Pharmacopeia (JP; 17^th edition*), analysis of trehalose hydrate should be carried out with an assay that meets following requirements. The SUGAR KS-801 confirmed the requirements were met.

System suitability requirements:
   The elution order: maltotriose, trehalose, glucose, internal standard (glycerin)
   Resolution (maltotriose/trehalose): ≥ 1.5
   Resolution (trehalose/glucose): ≥ 4
   Resolution (glucose/glycerin): ≥ 3
   Relative standard deviation (RSD) of six analyses
   (peak areas of trehalose and internal  standard ratio) : ≤ 1.0 %

*The version at the time of the application acquisition.


Sample : 20 μL
0.5 % each
1. Maltotriose
2. Trehalose
3. Glucose
4. Glycerin

Column       : Shodex SUGAR KS-801 (8.0 mm I.D. x 300 mm)
Eluent       : H2O
Flow rate    : 0.4 mL/min
Detector     : RI
Column temp. : 80 °C