According to United States Pharmacopeia and the National Formulary (USP 40-NF 35*), the assay of dextrose (D-glucose) and the analysis of related substances should be analyzed using a column packed with L19. It is necessary for the system suitability to satisfy resolution (Rs) between maltotriose and maltose of ≥ 1.3. It was confirmed to satisfy the system suitability when sample solution A was analyzed using SUGAR SC1011.
*The version at the time of the application acquisition.
Sample : 20μL
System suitability solution : Maltotriose, Maltose, Fructose 1mg/mL each (in H2O)
Sample solution A : Dextrose (D-Glucose) 30mg/mL(in H2O)
1. Maltotriose, 2. Maltose, 3. Dextrose, 4. Fructose
Column : Shodex SUGAR SC1011 (8.0mmI.D. x 300mm) Eluent : H2O Flow rate : 0.3mL/min Detector : Shodex RI Column temp. : 85°C