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氯分析仪测定氯化钠含量的方法验证

  • 方舸 杨燕珠 周世忠 涂晶
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  • 430060 武汉生物制品研究所质量保证部

网络出版日期: 2025-08-16

Verification of analyzer method for determination of sodium chloride content using chlorine analyzer

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  • Biochemistry Group in Quality Assurance, Wuhan Institute of Biological Products, Wuhan 430060,China 

Online published: 2025-08-16

摘要

目的  验证CL925型氯分析仪测定氯化钠含量的方法。方法  进行线性试验、精密度试验、准确性试验及专属性试验比较仪器法和法定方法测定氯化钠含量的结果。结果  线性关系良好,决定系数为0.9999,精密度好,平均回收率为100.4%。两种方法测得的氯化钠含量结果的差异无统计学意义。 结论  CL925型氯分析仪测定法达到了验证的可接受标准,适合测定氯化钠含量。

本文引用格式

方舸 杨燕珠 周世忠 涂晶 . 氯分析仪测定氯化钠含量的方法验证[J]. 国际生物制品学杂志, 2011 , 34(5) : 243 -251 . DOI: 10.3760/cma.j.issn. 1673-4211.2011.05.004

Abstract

Objective  To verify instrument method for determination of sodium chloride content using chlorine analyzer CL925.  Methods  Linear test, precision test, accuracy (recovery) and specificity tests were performed to compare the instrument method and the legal method for determination of sodium chloride content.  Results  There were a good linear relationship (R2=0.9999) and precision. The average recovery rate was 100.4 %, respectively. No statistically significant difference in the results of determination of sodium chloride content was noted between the instrument method and legal method. Conclusion  The instrument method reaches acceptable standards of verification and is suitable for determination of sodium chloride content.
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