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

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According to the Japanese Pharmacopeia (JP; 17th edition*), Analysis of miglitol should meets following requirements. The NH2P-50 4E confirmed the requirements were met.

System suitability requirements:
   Theoretical plate number: ≥ 5,000
   System factor: ≤ 1.5
   Relative standard deviation (RSD) of six analyses: ≤ 1.0%

*The version at the time of the application acquisition.


Sample : 20 μL
1. Miglitol 1 mg/mL


Column       : Shodex Asahipak NH2P-50 4E (4.6 mm I.D. x 250 mm)
Eluent       : (4.5 mM KH2PO4+0.47 mM Na2HPO4 aq.)/CH3CN=25/75
Flow rate    : 0.7 mL/min
Detector     : UV (210 nm)
Column temp. : 35 °C

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