According to the Japanese Pharmacopoeia (JP XVII*), “Assay" and "(4) Related substances" for “Trehalose Hydrate" should be carried out with a column filled with strong acidic ion-exchange resin consist of styrene divinylbenzene copolymer carrying sulfonic acid groups. The SUGAR KS-801 confirmed the requirements were met.

System suitability requirementsElution order (Solution for system performance): maltotriose, trehalose, glucose, the internal standard (glycerin)
Resolution between maltotriose and trehalose (Solution for system performance): ≥ 1.5
Resolution between trehalose and glucose (Solution for system performance): ≥ 4
Resolution between glucose and the internal standard (Solution for system performance): ≥ 3
Relative standard deviation (RSD) of the peak area of trehalose (Standard solution): ≤ 1.0% (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 20 µL
(Solution for system performance) 0.5 % each of Maltotriose, Trehalose, Glucose and Glycerin in H₂O (prepared according to JP method)

1. 1.Maltotriose
2. 2.Trehalose
3. 3.Glucose
4. 4.Glycerin