Validation of bacterial endotoxin test for aluminum hydroxide adjuvant by TAL method

VernacularTitle:氢氧化铝佐剂细菌内毒素凝胶法检测方法验证
Author: Yu PANG ¹ ; Mengxue ZHANG ; Zhijing MA ; Fei WANG ; Xuan GUO ; Xingping HAO ; Chengjin SUN
Author Information

1. 国药中生生物技术研究院有限公司质量检定室,北京 101111
Keywords: aluminum hydroxide adjuvant; bacterial endotoxin; orthogonal design; Ca-Mg additive; interference test; TAL gel-clot method
From: Drug Standards of China 2024;25(4):380-386
CountryChina
Language:Chinese
Abstract: Objective:To establish a TAL gel-clot bacterial endotoxin test for aluminum hydroxide adjuvant.Methods:According to the bacterial endotoxin test in general chapter 1143 of the Chinese Pharmacopoeia 2020,pre-interference test was performed using 3 types of buffer solutions and Ca-Mg additive by orthogonal design.The interference test and sample preparation validation were carried out using different batches of aluminum hydroxide adjuvant from 2 TAL manufacturers.Results:No interference was obtained through pre-interference test.Under the validated conditions,aluminum hydroxide adjuvant combined with phosphate buffered saline and Ca-Mg additive was employed to remove interference in bacteria endotoxin test.Conclusion:The established TAL gel-clot method is applicable to bacterial endotoxin test for aluminum hydroxide adjuvant.