Study on bacterial endotoxin test of iron sucrose injection
REN Wei
LI Xin
Abstract：Objective:To set up the bacterial endotoxin determination method of iron sucrose injection (the gel-clot method) for the quality control of the drug and prevention of pyrogen reaction in clinical practice.Methods:The experiment was performed according to the Chinese Pharmacopoeia 2015 edition (4). A systematic study was carried out to investigate the interferences of iron sucrose injection with limulus reagent and agglutination reaction to bacterial endotoxin in order to detect the non-interference concentration of bacterial endotoxin.Results: There was no interference in the bacterial endotoxin test when iron sucrose injection was diluted 20-fold. The results of 8 batches of samples from 2 manufacturers complied with the requirements. Conclusion: The established method of endotoxin test was feasible, accurate and repeatable for iron sucrose injection.
Keywords：Iron sucrose injectionBacterial endotoxinTachypleus amebocyte lysateInterference test
Publication Date：2016-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：3( 148-150 )