The draft for public consultation of the Pharmaceutical Excipient Standards of the Chinese Pharmacopoeia for Lactitol Monohydrate, 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. Although a shoulder peak of lactose was observed in the chromatogram and is unavoidable due to impurities in lactitol, the requirement was met.

System suitability requirementResolution between each of lactose, glucose, and D‑lactitol monohydrate: ≥ 1.2

*The version at the time of the application acquisition.

Sample: 100 µL

1. 1.Lactose 0.05 mg/mL
2. 2.Glucose 0.05 mg/mL
3. 3.D-Lactitol 5 mg/mL