Insulin glargine is an analogue of human insulin and biological medicine of insulin. According to the JP method, purity test of high-molecular proteins in insulin glargine should be analyzed using a column packed with hydrophilic silica gel. It is necessary for the system suitability to satisfy resolution (high-molecular proteins / insulin glargine) ≥ 1.5 and relative standard deviation (RSD) of ≤ 2.0% (repeated six times). It was confirmed that the all conditions were satisfied when they were analyzed using PROTEIN KW-802.5.
Sample : 100 μL
System suitability solution (prepared according to JP method)
1. High molecular weight proteins
2. Insulin glargine
Column : Shodex PROTEIN KW-802.5 (8.0mmI.D. x 300mm) x 2 Eluent : CH3COOH/CH3CN/H2O=20/30/50 (pH to 3.0 adjusted with 25% NH3 aq.) Flow rate : 0.5mL/min Detector : UV(276nm) Column temp. : 25°C
