According to the Japanese Pharmacopoeia (JP XVII*), “Assay" and "(8) Related substances" for “Maltose Hydrate" should be carried out with a column filled with strong acidic ion-exchange resin gel. The SUGAR KS-801 confirmed the requirements were met.
"In the JP, the column length is specified as approximately 55 cm. The column length of the KS-801 is 30 cm, but it fully meets the system suitability requirements. (As long as a column meets the system suitability requirements, the use of a different column length is allowed.)"

System suitability requirementsElution order (Solution for selection of column): maltose, glucose, ethylene glycol
Resolution between maltose and glucose (Solution for selection of column): ≥ 4

*The version at the time of the application acquisition.

Sample: 20 µL
(Solution for selection of column) 2.5 mg/mL each of Maltose and Glucose, and 4 mg/mL of Ethylene glycol in H₂O

1. 1.Maltose
2. 2.Glucose
3. 3.Ethylene glycol