Establishment of the first batch of reference standard of imipenem
DUAN Yu
TIAN Ye
XIE Jing-xin
ZHU Li
YIN Li-hui
Abstract：Objective:To develop the first batch of reference standard of imipenem in order to provide assurance for the quality control of related preparations in China.Methods:The structure of imipenem was confirmed by IR,LC-HRMS and NMR.The content of imipenem was determined by mass balance method,and was further supported by quantitative nuclear magnetic resonance and external standard method to ensure the accuracy of the quantitative value.The uniformity and stability of the sample were studied using HPLC to ensure the uniformity and stability of imipenem reference substance.Results:The content of national reference standard of imipenem was calculated by mass balance method,with the amount of imipenem(C12H17N3O4S)93.2％.Conclusion:The first batch of national reference standard of imipenem was successfully established,which can be used for the identification and content determination of imipenem raw materials and related preparations.
Keywords：imipenemnational reference substancemass balance methodscontent determinationcontent assignment
Publication Date：2024-11-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2299-2304 )