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作 者:卞静 张倩 BIAN Jing;ZHANG Qian(Jiangsu Original Drug Research and Development Co.,Ltd.,Lianyungang 222000,China)
机构地区:[1]江苏原创药物研发有限公司,江苏连云港222000
出 处:《化工管理》2024年第8期72-75,共4页Chemical Engineering Management
摘 要:文章介绍分别用电感耦合等离子体质谱法(ICP-MS)和石墨炉原子吸收分光光度法(GFAAS)进行一次性输液管线中锡元素含量分析方法验证,验证内容包含检出限、定量限、重复性、准确度(回收率)、中间精密度。验证数据表明所得到的各项检测结果均符合规定并且达到验证的可接受标准,证明两种方法均适用于本品中锡元素的检验,能保证检验的准确性、可靠性。比较分析该两种方法检测一次性输液管线中锡含量,重现性良好。This paper introduces the veri fication of tin content analysis methods by inductively coupled plasma mass spectrometry(ICP-MS)and graphite furnace atomic absorption spectrometry(GFAAS).The veri fication contents include detection limit,quantitation limit,repeatability,accuracy(recovery rate)and intermediate precision.The veri fication data show that the obtained test results are in line with the regulations and meet the acceptable standards of veri fication,which proves that the two methods are suitable for the inspection of tin elements in this product,and can ensure the accuracy and reliability of the inspection.The two methods were compared and analyzed to detect tin content in disposable infusion pipeline with good reproducibility.
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