Insulin glargine is an analogue of human insulin and is a biological medicine. According to the Japanese Pharmacopoeia (JP XVII*), “Assay” and "(3) Related substances" for “Miglitol" should be carried out with a column filled with pentaethylenehexaaminated polyvinyl alcohol polymer beads. The Asahipak NH2P-50 4E confirmed the requirements were met.

System suitability requirementsTheoretical plate number of miglitol peak (Standard solution): ≥ 5,000
System factor of miglitol peak (Standard solution): ≤ 1.5
Relative standard deviation (RSD) of the peak area of miglitol (Standard solution): ≤ 1.0% (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 20 µL
(Standard solution) 1 mg/mL of Miglitol in eluent

1. 1.Miglitol