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Analysis of Miglitol According to JP Method (NH2P-50 4E)

The 17th edition of the JP (Japanese Pharmacopoeia) came into effect on April 1, 2016. Miglitol was added to the 17th edition of the JP. According to the JP method, it is necessary for the system suitability to satisfy theoretical plate number of ≥ 5,000 and symmetry factor of ≤ 1.5, and for the system repeatability to satisfy relative standard deviation (RSD) of ≤ 1.0% (repeated six times). It was confirmed that the all conditions were satisfied when miglitol was analyzed using Asahipak NH2P-50 4E.

Sample : 20μL
1. Miglitol 1mg/mL

Column : Shodex Asahipak NH2P-50 4E (4.6mmI.D. x 250mm)

Eluent : (4.5mM KH2PO4+0.47mM Na2HPO4 aq.)/CH3CN=25/75

Flow rate : 0.7mL/min

Detector : UV(210nm)

Column temp. : 35°C