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; 17th edition*), analysis of mannitol should meets following requirements. The SC1011-7F confirmed the requirements were met.
System suitability requirements:
Resolution of mannitol and sorbitol: ≥ 2.0
*The version at the time of the application acquisition.
Sample : 25mg/mL each, 20µL
1. Mannitol
2. Sorbitol
Sample : 1mg/mL each, 20µL
3. Isomalt (= Palatinit)
4. Maltitol
Column : Shodex EP SC1011-7F (7.8mmI.D. x 300mm) Eluent : H2O Flow rate : 0.5mL/min Detector : Shodex RI Column temp. : 85°C
