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Analysis of Mannitol According to Pharmacopeia Method (SC1011-7F)

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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 : 25 mg/mL each, 20 µL
1. Mannitol
2. Sorbitol



Sample : 1 mg/mL each, 20 µL
3. Isomalt (= Palatinit)
4. Maltitol
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. : 85 °C

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