According to the United States Pharmacopeia and the National Formulary Pharmacopeial Forum (PF 45(5)*), sucrose assay and analysis of impurities (related substances) should be carried out with a HPLC method and a column filled with L19 packing material, and meets following requirements.
The use of a sugar analysis column, EP SC1011-7F, confirmed the requirements were met.
System suitability requirements:
Peak valley ratio of raffinose and sucrose: ≥ 2.5
Resolution of sucrose and dextrose: ≥ 1.5
Relative standard deviation (RSD) of sucrose peak area: ≤ 0.73%
*The version at the time of the application acquisition.
Sample : 10 μL
1. Raffinose 0.05 mg/mL
2. Sucrose 10 mg/mL
3. Dextrose(D-Glucose)Â 0.05 mg/mL
4. Fructose 0.05 mg/mL
Column : Shodex EP SC1011-7F (7.8 mm I.D. x 300 mm) Eluent : H2O Flow rate : 0.5 mL/min Detector : Shodex RI Column temp. : 80 °C
