中国药业2024,Vol.33Issue(23) :82-85.DOI:10.3969/j.issn.1006-4931.2024.23.018

橡胶类药品包装材料灰分测定的能力验证研究

Proficiency Testing for the Determination of Ash Content of Rubber Pharmaceutical Packaging Materials

贾菲菲 程佳美 杨梦雨 赵霞 杨会英
中国药业2024,Vol.33Issue(23) :82-85.DOI:10.3969/j.issn.1006-4931.2024.23.018

橡胶类药品包装材料灰分测定的能力验证研究

Proficiency Testing for the Determination of Ash Content of Rubber Pharmaceutical Packaging Materials

贾菲菲 1程佳美 1杨梦雨 1赵霞 1杨会英1
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作者信息

  • 1. 国家药品监督管理局药用辅料质量研究与评价重点实验室·中国食品药品检定研究院,北京 100050
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摘要

目的 提升实验室对橡胶类药品包装材料的检测能力.方法 按中国合格评定国家认可委员会(CNAS)相关文件要求,对能力验证样品进行均匀性和稳定性检验,分析各参加实验室的灰分测定结果,采用z比分数对参加实验室的能力验证结果满意度进行评价.结果 能力验证样品均匀、稳定;参加能力验证的59家实验室中,收回58家实验室的能力证验结果,结果评定均为满意,满意率为98.31%.结论 参加能力证验的实验室对橡胶类药品包装材料灰分的检测能力总体良好.

Abstract

Objective To improve the the capabilities of laboratories in the determination of rubber pharmaceutical packaging materials.Methods According to the relevant documents of the China National Accreditation Service for Conformity Assessment(CNAS),the uniformity and stability tests were conducted on the proficiency testing samples,and the ash content determination results from each participating laboratory were analyzed.The robust z-scores were used to evaluate the satisfaction of the proficiency testing results of the participating laboratories.Results The proficiency testing samples were uniform and stable.Among the 59 laboratories that participated in the proficiency testing,58 laboratories retrieved their proficiency test results,and the results were evaluated as satisfactory,with a satisfaction rate of 98.31%.Conclusion The laboratories participating in the proficiency testing have an overall good ability to detect the ash content of rubber pharmaceutical packaging materials.

关键词

能力验证/橡胶/药品包装材料/灰分

Key words

proficiency testing/rubber/pharmaceutical packaging materials/ash content

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出版年

2024
中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
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