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Analysis of Insulin Glargine According to USP Method (KW-802.5)


Insulin glargine is an analogue of human insulin and biosimilar of insulin. According to USP 39 method, insulin glargine should be analyzed using a column packed with L20. It is necessary for the system suitability to satisfy tailing factor for insulin glargine of ≤ 2.0 and *resolution ≥ 2. It was confirmed that the tailing factor was lower than 1.0, and insulin glargine and the high molecular weight proteins were completely separated when they were analyzed using PROTEIN KW-802.5.
*resolution : The ratio of the height of the high molecular weight protein’s peak to the height of the valley between the high molecular weight proteins peak and the insulin glargine peak.

Sample : 100μL
System suitability solution (prepared according to USP 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. : Ambient

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