According to JP (Japanese Pharmacopoeia) method, assay of trehalose hydrate, it is necessary for the system suitability to satisfy the following.
– The elution order : maltotriose, trehalose, glucose and the internal standard (= glycerin)
– The resolution : ≥ 1.5 (maltotriose / trehalose), ≥ 4 (trehalose / glucose) and ≥ 3 (glucose / the internal standard)
– The relative standard deviation (RSD) of the ratio of the peak area of trehalose to that of the internal standard : ≤ 1.0% (repeated six times)
It was confirmed that the all conditions were satisfied when analyzed using SUGAR KS-801, a column for sugar analysis.
Sample : 0.5% each, 20μL
Column : Shodex SUGAR KS-801 (8.0mmI.D. x 300mm) Eluent : H2O Flow rate : 0.4mL/min Detector : Shodex RI Column temp. : 80°C