Investigation on bacterial endotoxins test of vidarabine monophosphate for injection

VernacularTitle:注射用单磷酸阿糖腺苷细菌内毒素检查方法研究
Author: CHEN Suzhen ; ZENG Qiumin ; WU Yanhong
Publication Type:Journal Article
Keywords: vidarabine monophosphate for injection; bacterial endotoxin test; quality standards; interference test; gel-clot method; Tachypleus Amebocyte Lysate (TAL)
From: Drug Standards of China 2024;25(1):068-071
CountryChina
Language:Chinese
Abstract: Objective: To establish a bacterial endotoxin detection method for vidarabine monophosphate for injection and conduct methodological validation for harmanizing the quality control standard of this product.
Methods: According to the Chinese Pharmacopoeia 2020 volume Ⅳ general chapter 1143“Bacterial endotoxin test”, the limit of bacterial endotoxin was determined,interference test and endotoxin testing were performed.
Results: The bacterial endotoxin test were performed on 25 batches of test samples provided by 15 manufacturers according to the experienced experimented limitation which is the amount of endotoxin in 1 mg of adenosine monophosphate should be less than 0.06 EU. All results were found to be in compliance with the specified standards.
Conclusion: The established bacterial endotoxin method can be used for quality control of vidarabine monophosphate for injection.
Full text:202408101322541324820240211.pdf