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利用天平密度组件测定药包材密度的不确定度分析

鹿麟 矫建 贺建华 贾瑞波

中国药物评价2023,Vol.40Issue(6):494-497,4.
中国药物评价2023,Vol.40Issue(6):494-497,4.

利用天平密度组件测定药包材密度的不确定度分析

Evaluation of Uncertainty for Density Determination of Drug Packaging Materials with Density Measuring Unit on Balance

鹿麟 1矫建 1贺建华 1贾瑞波1

作者信息

  • 1. 大连市药品检验检测院,辽宁大连 116021
  • 折叠

摘要

Abstract

Objective:To establish evaluation methodofuncertainty for density determination of drug packaging materials with den-sity measuring unit on balance.Methods:According to General Rule 4012 Determinationofdensity,Part Ⅳ,Chinese Pharmacopoeia 2020,determined with the density measuring unit on balance.The possible sources of uncertainty in the measurement results both with and without air density compensation were analyzed,and the evaluation methods of uncertainty of the two measurement results were established.Results:Measurement result without air density compensation is(0.963 1±0.001 2)g·cm-3,k=2.And measurement result with air density compensation is(0.962 9±0.001 2)g·cm-3,k=2.Conclusion:The impregnant density and measurement repeatability are the main sources of uncertainty in the density determination of drug packaging materials.This e-valuation method is reasonable and accurate,and can provide reference for the uncertainty evaluation of the density determination of drug packaging materials in the laboratory.

关键词

不确定度/药包材/密度/天平密度组件/空气密度补偿

Key words

Uncertainty/Drug packaging materials/Density/Density measuring module on balance/Air density compensation

分类

医药卫生

引用本文复制引用

鹿麟,矫建,贺建华,贾瑞波..利用天平密度组件测定药包材密度的不确定度分析[J].中国药物评价,2023,40(6):494-497,4.

中国药物评价

2095-3593

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