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Analysis of Maltose Hydrate According to JP Method (KS-801)


According to the Japanese Pharmacopeia (JP; 17th edition*), analysis of maltose hydrate should be carried out with a column filled with strong acid cation exchange gel and meets following requirements. The SUGAR KS-801 confirmed the requirements were met. Note that the JP indicates to use a 55 cm column, however a 30 cm KS-801 column effectively separates the targets while satisfying the requirements (as long as a column meets the required system suitability, the use of different column length is allowed).

System suitability requirements:
   Elution order: maltose, glucose, ethylene glycol;
   Resolution (maltose/glucose): ≥ 4

*The version at the time of the application acquisition.

Sample : 20 µL
1. Maltose 2.5 mg/mL
2. Glucose 2.5 mg/mL
3. Ethylene glycol 4 mg/mL
*dissolved in H2O

Column       : Shodex SUGAR KS-801 (8.0 mm I.D. x 300 mm)
Eluent       : H2O
Flow rate    : 0.35 mL/min
Detector     : Shodex RI
Column temp. : 50 °C

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