Exenatide, a peptide consisting of 39 amino acids, is widely used as a type 2 diabetes drug for GLP-1 analogues.
According to the United States Pharmacopeia and the National Formulary (USP 42-NF 37*) method,
analysis of exenatide injection assay should be carried out with a column filled with L20 packing material and meets following requirements. Analysis using PROTEIN KW-802.5 meets all the following system suitability requirements.

System suitability requirements:
    Resolution of exenatide and soybean trypsin inhibitor peaks: Rs ≥ 1.3
    Tailing factor range of exenatide: 0.8 – 1.4
    Relative standard deviation (RSD) ≤ 2.0%

*The version at the time of the application acquisition. 


Sample : System suitability solution, 20 μL
1. Soybean trypsin inhibitor
2. Exenatide

Column       : Shodex PROTEIN KW-802.5 (8.0 mm I.D. x 300 mm)
Eluent       : 0.13 M Na2SO4 aq./CH3CN/TFA=1500/500/2
Flow rate    : 0.8 mL/min
Detector     : UV (214 nm)
Column temp. : 25 °C