Development of impurity reference substance for quetiapine fumarate
LI Zeng-xin
ZHOU Xiao-li
ZHANG Jin-ze
LIU Wan-hui
YIN Li-hui
Abstract：Objective:The impurity reference substances B,G,H,and I were calibrated and developed,which can be used for the inspection of relevant national standards and related substances of this variety.Methods:The structures of impurities B,G,H and I were identified by LC-MS and NMR.HPLC method was used for purity analysis,mass balance method was used to calculate the content of various impurities,and quantitative nuclear magnetic resonance was used to assist in calibration.Results:The contents of impurities B,G,H and I are 98.00%,99.28%,98.94%and 97.84%,respectively.Conclusion:The first batch of national standard substances of impurities B,G,H and I of quetiapine fumarate was successfully developed,satisfying the quality control needs of quetiapine fumarate and its formulations in China.
Keywords：impurity of quetiapine fumaratestandard substancesstructure confirmationmass balance methodquantitative nuclear magnetic resonance
Publication Date：2024-07-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1390-1395 )