关键词: 不确定度, 药包材, 密度, 天平密度组件, 空气密度补偿

Abstract: Objective： To establish evaluation methodofuncertainty for density determination of drug packaging materials with density 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 evaluation method is reasonable and accurate， and can provide reference for the uncertainty evaluation of the density determination of drug packaging materials in the laboratory.

Key words: Uncertainty, Drug packaging materials, Density, Density measuring module on balance, Air density compensation