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 Human (Genetical Recombination)" and "Insulin Human (Genetical Recombination) Injection" should be carried out with a column filled with hydrophilic silica gel. The PROTEIN KW-802.5 confirmed the requirements were met.

System suitability requirementsPeak height of the dimer (Human insulin dimer-containing Test Solution): 10 - 50% of the full scale
Elution order (Human insulin dimer-containing Test Solution): polymer, dimer, monomer
Peak-to-valley ratio** (Human insulin dimer-containing Test Solution): ≥ 2.0

Sample: 100 µL
(Human insulin dimer-containing Test Solution) 4.0 mg/mL of human Insulin in 0.01 N HCl aq. (prepared according to JP method)

1. 1.Insulin polymer
2. 2.Insulin trimer
3. 3.Insulin dimer
4. 4.Insulin monomer