Insulin glargine is an analogue of human insulin and is a biological medicine. According to the Japanese Pharmacopoeia (JP XVII*), “(2) High-molecular mass proteins” for “Insulin Glargine (Genetical Recombination)" and "Insulin Glargine (Genetical Recombination) Injection" should be carried out with two columns (8.0 mm (I.D.) x 30 cm (length) each) filled with hydrophilic silica gel in series. Use of two PROTEIN KW-802.5 columns in series confirmed the requirements were met.

System suitability requirementsPeak area of insulin glargine obtained the ten-fold "Solution for system suitability test": 5 - 15% of peak area of insulin glargine obtained "Solution for system suitability test"
Elution order (Solution for system suitability test): high-molecular mass proteins, insulin glargine
Resolution between High-molecular mass proteins and insulin glargine (Solution for system performance): ≥ 1.5
Relative standard deviation (RSD) of peak area of insulin glargine (Solution for system suitability test): ≤ 2.0％ (repeated 6 times)

*The version at the time of the application acquisition.

Sample: 100 µL
(Solution for system suitability test) prepared according to JP method

1. 1.High-molecular mass proteins
2. 2.Insulin glargine