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


Insulin glargine is an analogue of human insulin and biosimilar of insulin. According to the United States Pharmacopeia and the National Formulary (USP 39-NF 34*), analysis of insulin glargine should be carried out with a column filled with L20 packing material and meets following requirements. The PROTEIN KW-802.5 confirmed the requirements were met.

System suitability requirements:
 Resolution**: ≥ 2
 Relative standard deviation (RSD): ≤ 2.0%
 Tailing factor of insulin glargine: ≤ 2.0

*The version at the time of the application acquisition. 
**The ratio of the height of the high molecular weight protein peak to the height of the valley between the high molecular weight protein peak and the insulin glargine peak.

Sample : 100 μL
System suitability solution (prepared according to USP-NF method)
1. High molecular weight protein
2. Insulin glargine

Column       : Shodex PROTEIN KW-802.5 (8.0 mm I.D. x 300 mm) x 2
Eluent       : CH3COOH/CH3CN/H2O = 20/30/50 (pH to 3.0 adjusted with 25 % NH3 aq.) 
Flow rate    : 0.5 mL/min
Detector     : UV (276 nm)
Column temp. : Ambient

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