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

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

System suitability requirements:
   Theoretical plate number: ≥ 7,000
   Symmetry factor: 0.8 – 1.2
   Relative standard deviation (RSD) of six analyses: ≤ 3.0%

*The version at the time of the application acquisition.

[Note] This analysis requires column equilibration.
For column equilibration: First introduce 100 mM Sodium phosphate buffer (pH6.5) at 0.5 mL/min for 2 hours, and then switch to the eluent at 0.5 mL/min for 2 hours.

Sample : 10 μg/mL, 50 μL
1. Voglibose

Column       : Shodex Asahipak NH2P-50 4E (4.6 mm I.D. x 250 mm)
Eluent       : 20 mM Sodium phosphate buffer (pH6.5)/CH3CN=37/63	
Reagent	     : 12 mM NaIO4 + 50 mM Taurine aq.
Flow rate    : (Eluent) 0.6 mL/min (Reagent) 0.5 mL/min
Detector     : Fluoresence (Ex. 350 nm, Em. 430 nm) (post-column reaction)
Column temp.   : 25 °C
Reaction temp. : 100 °C
Cooling temp.  : 15 °C

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