Development of the first batch of saxagliptin monohydrate national control product
ZHAI Chen-fei
FENG Yu-fei
LUO Chen
LIU Qian
YANG Dong-sheng
Abstract：Objective:To establish the first batch of the national reference standard for saxagliptin.Methods:The structure of saxagliptin was confirmed by IR,NMR and LC-MS spectroscopy.The purity of saxagliptin was determined by HPLC,water content and residue on ignition were also determined,and the final content of saxagliptin was calculated using the mass balance method.Results:The structure of saxagliptin was confirmed,and the content was found to be 94.2%.Conclusion:The development of the first batch of saxogliptin chemical reference standard enables its use as a reference for the identification and content determination of saxagliptin raw material and its related preparations.
Keywords：saragliptincertification of standard materialmass balance methodsreference substanceHPLC
Publication Date：2026-03-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：5( 495-499 )