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Analysis of Sucrose Proposed in USP-NF Pharmacopeial Forum (SC1011-7F)


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)  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

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