According to the United States Pharmacopeia and the National Formulary (USP 42-NF 37*), "ASSAY" for "Exenatide Injection" should be carried out with a column filled with L20 packing material. The PROTEIN KW-802.5, a column filled with L20 packing material, confirmed the requirements were met.

System suitability requirementsResolution between exenatide peak and soybean trypsin inhibitor peak (System suitability solution): ≥ 1.3
Tailing factor (Standard solution)：0.8 - 1.4
Relative standard deviation (RSD) (Standard solution): ≤ 2.0%

*The version at the time of the application acquisition.

Sample: 20 µL
(System suitability solution) prepared according to USP-NF method

1. 1.Soybean trypsin inhibitor
2. 2.Exenatide