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化妆品中16α-羟基泼尼松龙含量的不确定度评定

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参考国家药品监督管理局关于发布《化妆品中16α-羟基泼尼松龙的测定》化妆品补充检验方法的公告(2022年第107号)中《化妆品中16α-羟基泼尼松龙的测定(BJH 202203)》对化妆品中16α-羟基泼尼松龙进行测定.同时依据JJF 1059.1-2012《测量不确定度评定与表示》标准,建立测定16α-羟基泼尼松龙的不确定度数学模型,并对不确定度的来源进行评定.结果显示,当化妆品中16α-羟基泼尼松龙含量为0.105 6mg/kg时,扩展不确定度为0.008 1 mg/kg(k=2,置信概率95%).不确定度的主要来源为标准曲线拟合及样品测量重复性.
Uncertainty evaluation for determination of 16alpha-hydroxyprednisolone in cosmetics
According to the supplementary determination method of 16alpha-hydroxyprednisolone in announcement by SDA(No.107 of 2022),the 16alpha-hydroxyprednisolone in cosmetics was detected.In accordance with JJF 1059.1-2012 Evalua-tion and Expression of Uncertainty in Measurement,a mathematical model for the determination of 16alpha-hydroxypred-nisolone was established and each source and uncertainty component were analyzed and evaluated.The results showed that the content of 16alpha-hydroxyprednisolone in cosmetics was 0.105 6 mg/kg and the relative expanded uncertainty of mea-surement result was 0.008 1 mg/kg(k=2,confiidence level 95%).The uncertainty mainly caused by calibration fitting and measurement repeating.

MetrologyTriple quadrupole mass spectrometryCosmetics16alpha-hydroxyprednisoloneUncertainty

刘齐、郭洁、王琪、张华珺

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北京市药品检验研究院 北京 102206

计量学 三重四极杆质谱法 化妆品 16α-羟基泼尼松龙 不确定度

2024

质量安全与检验检测
中国检验检疫科学研究院

质量安全与检验检测

影响因子:0.399
ISSN:2096-8876
年,卷(期):2024.34(6)