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永停滴定法测定磺胺间甲氧嘧啶钠注射液含量的不确定度评定
杨星,万仁玲
0
(中国兽医药品监察所)
摘要:
以磺胺间甲氧嘧啶钠注射液为例,阐述永停滴定法含量测定结果的不确定度评定。通过建立数学模型,分析不确定度来源,对各个不确定度分量进行了评估,计算了扩展不确定度,含量测定结果可表述为(95.3±0.8)%(k=2)。结果表明,重复性测量、校准和温度差异引入的不确定度为测量结果不确定度的主要来源。
关键词:  永停滴定法  磺胺间甲氧嘧啶钠注射液  含量测定  不确定度
DOI:
投稿时间:2014-11-20修订日期:2014-12-08
基金项目:
Uncertainty Evaluation in the Assay of Sulfamonomethoxine Sodium Injection by Dead-stop Titration
(China Institute of Veterinary Drug Control)
Abstract:
Taking sulfamonomethoxine sodium injection for example, the uncertainty of content determination by dead-stop titration was evaluated. A mathematical mode of uncertainty evaluation was established and the sources of uncertainty were analyzed and evaluated during the whole determination procedure. Finally the expanded uncertainty was calculated and the result of content determination can be expressed as (95.3±0.8)% (k=2). It showed that the main sources of measurement uncertainty were measurement repeatability, calibration and the laboratory temperature variation.
Key words:  dead-stop titration  sulfamonomethoxine sodium injection  assay  uncertainty

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