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Analysis of Sorbitol According to USP-NF Method (SP0810 8C)

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Exenatide is a peptide consisting of 39 amino acids that is widely used as a type 2 diabetes drug for GLP-1 analogues.
According to the United States Pharmacopeia and the National Formulary (USP-NF) method, for the assay of exenatide injection sorbitol, a column packed with L 20 packing is recommended for the analysis. It is necessary for the system suitability to satisfy, resolution of exenatide/soybean trypsin inhibitor of 1.3 or more, the tailing factor of exenatide of 0.8 to 1.4, and relative standard deviation (RSD) for exenatide of not more than 2.0%.
Analysis using PROTEIN KW-802.5(L20)meets all the system suitability requirements.

 
Sample :  10 μL
(System suitabilitysolution) 4.8 mg/g Mannitol and 4.8 mg/g Sorbitol
(Standard solution) 4.8 mg/g Sorbitol


Column       : Shodex SUGAR SP0810 8C (8.0 mm I.D. x 100 mm)
Eluent       : H2O 
Flow rate    : 0.7 mL/min
Detector     : Shodex RI (35 °C)
Column temp. : 50 °C