The Chinese Pharmacopoeia 2025 Edition*, Part IV, under “Mannitol” monograph, analysis of related substances by high performance liquid chromatography (HPLC) “Tests” section specifies the use of a column packed with strong cation exchange resin (calcium form) in which sulfonic acid groups are bonded to a cross linked styrene divinylbenzene copolymer or a column with equivalent separation performance. SUGAR SC1011 column confirmed the requirements were met. SC1011 column is also applicable to the “Assay” test.

System suitability requirementsResolution between mannitol and sorbitol: > 2.0
Resolution between maltitol and the first peak of isomalt: ≥ 1.5

*The version at the time of the application acquisition.

Sample: 25 µL
25 mg/mL each

1. 1.Mannitol
2. 2.Sorbitol

Sample: 25 µL
1 mg/mL each

1. 3.Isomalt (= Palatinit)
2. 4.Maltitol