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Analysis of Trehalose According to USP-NF Method (KS-801)


According to the United States Pharmacopeia and the National Formulary (USP 40-NF 35*), the assay of trehalose and the analysis of related substances should be carried out with a column with L58 packing material and meets following requirements. The SUGAR KS-801 confirmed the requirements were met.

System suitability requirements:
   Resolution of trehalose and maltotriose: ≥ 1.5
   Relative standard deviation (RSD) of trehalose peak area: ≤ 2.0%

*The version at the time of the application acquisition.

Sample : 0.25 % each, 20 µL
1. Maltotriose
2. Trehalose
3. Glucose

Column       : Shodex SUGAR KS-801 (8.0 mm I.D. x 300 mm)
Eluent       : H2O
Flow rate    : 0.4 mL/min
Detector     : Shodex RI
Column temp. : 80 ℃

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