摘要
建立干粉筒易氧化物测定方法的不确定度评定方法。依据YY/T 1494-2016[1]要求测定干粉筒中的易氧化物并分析其不确定度来源并进行不确定度结果的评定。干粉筒易氧化物的测定结果为0.21 mL,合成不确定度为0.01 mL,扩展不确定度为0.02 mL,结果表示为:(0.21±0.02)mL(k=2,置信概率为95%);不确定度的主要来源是测量的重复性,该方法可帮助检验人员确定结果的准确性和可靠度。
An uncertainty evaluation method for the determination of the reducing substances in the powder bicarbonate cartridge was established.The reducing substances in powder bicarbonate cartridge for oral liquid preparation was determined and their uncertainty was evaluated based on YY/T 1494-2016.The determination result of powder bicarbonate cartridge was 0.21 mL,the combined uncertainty of reducing substances in the powder bicarbonate cartridge was 0.01 mL and the expanded uncertainty was 0.02 mL.Uncertainty result was expressed as(0.21±0.02)mL(k=2,coverage probability was 95%).The main source of uncertainty was measurement repeatability,this method could help inspectors to determine the accuracy and reliability of the results.
作者
郑杰
谢敬科
ZHENG Jie;XIE Jing-ke(Guangdong Medical Device Quality Sureillance and Test,Guangdong Guangzhou 510700,China)
出处
《广州化工》
CAS
2023年第12期176-178,共3页
GuangZhou Chemical Industry
关键词
干粉筒
易氧化物
不确定度
powder bicarbonate cartridge
reducing substances
uncertainty