According to the United States Pharmacopeia and the National Formulary (USP 37-NF 32*), the European Pharmacopoeia (EP 9.0*) and The Japanese Pharmacopoeia (JP XVII*), Assay and analysis of related substances for "Mannitol" should be carried out with a column filled with Strong cation-exchange resin (calcium form) consisting of sulfonated cross-linked styrene divinylbenzene copolymer (USP-NF L19), and that meets following requirement. The EP SC1011-7F, a column filled with L19 packing material, confirmed the requirement was met.

System suitability requirementResolution between mannitol and sobitol: ≥ 2.0

*The version at the time of the application acquisition.

Sample: 20 µL
(System suitability solution A for USP-NF) 25 mg/mL each of D-Mannitol and Sorbitol in H₂O
(System suitability solution B for USP-NF) 1 mg/mL each of Isomalt and Maltitol in H₂O

1. 1.Isomalt
2. 2.Maltitol
3. 3.Mannitol
4. 4.Sorbitol