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动态浊度法定量检测能力验证样品中细菌内毒素含量及分析

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检测能力验证样品中细菌内毒素的含量和分析检测过程的注意事项.依据《中国药典》2020 年版 4 部通则 1143 细菌内毒素检查法的光度测定法中的动态浊度法.建立细菌内毒素检查的标准曲线,通过预实验确定样品最佳稀释倍数及预估细菌内毒素含量,并选定最佳稀释倍数对样品中细菌内毒素含量进行独立平行 3 次检测.细菌内毒素检测浓度线性范围为 0.0625~1.0 EU/mL,标准曲线为LgT=2.8059+(-0.28966LgC)(|r|值=0.9982);样品在稀释1000 倍时对试验无干扰作用;细菌内毒素回收率50%~200%;3次平行检测结果T1、T2、T3 分别为83.80 EU/mL、82.70 EU/mL、83.00 EU/mL.动态浊度法测定该能力验证样品的检测方法可靠、结果准确、稳定.
The Kinetic Turbidimetric Assay was used to Determine the Content of Bacterial Endotoxin in Samples
To determinate the concentration of bacterial endotoxin in proficiency testing samples and analyze the matters needing attention in the inspection process.According to the method of ChP 2022.Vol Ⅳ:1143.The kinetic turbidimetric method of photometric determination of bacterial endotoxin.Establish a standard curve of bacterial endotoxin test.The optimal dilution ratio and bacterial endotoxin content were determined by pre-experiment.The optimal dilution ratio was selected to determine the bacterial endotoxin content in the samples for three independent and parallel tests.The linear range of bacterial endotoxin was 0.0625~1.0 EU/mL.The standard curve is LgT=2.8059+(-0.28966LgC)(|r|=0.9982).The endotoxin test wasnt interfered by 1000 times diluted solution.The recovery rate of bacterial endotoxin was 50%~200%.The results of T1,T2 and T3 were 83.80 EU/mL,82.70 EU/mL and 83.00 EU/mL.The kinetic turbidimetric method is reliable,accurate and stable for the proficiency testing samples.

proficiency testing samplesbacterial endotoxinkinetic turbidimetric methodcontent determination

黄佳慧、何冬华、崔碧玲

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东莞市食品药品检验所,广东 东莞 523000

能力验证样品 细菌内毒素 动态浊度法 含量检测

2024

广东化工
广东省石油化工研究院

广东化工

影响因子:0.288
ISSN:1007-1865
年,卷(期):2024.51(11)