According to the United States Pharmacopeia and the National Formulary (USP 41-NF 36*), "ASSAY" for "Maltitol" and "Maltitol Solution" should be carried out with a column filled with L34 packing material. The SUGAR SP0810 8C, a column filled with L34 packing material, confirmed the requirements were met.

System suitability requirementsMaltitol
Resolution between maltitol and sorbitol (System suitability solution): ≥ 2.0
Relative standard deviation (RSD) (Standard solution): ≤ 2.0%

Maltitol Solution
Tailing factor of maltitol and sorbitol (Standard solution): ≤ 1.2
Relative standard deviation (RSD) (Standard solution): ≤ 2.0%

*The version at the time of the application acquisition.

Sample: 10 µL
(Standard solution) 10 mg/g of Maltitol and 1.6 mg/g of Sorbitol
(System suitability solution) 4.8 mg/g each of Maltitol and Sorbitol

1. 1.Maltitol
2. 2.Sorbitol