摘要
目的:系统评估不同来源和级别(药用级和化工级)硬脂酸中多种金属元素的残留情况,并探讨生产工艺对这些残留的影响,为质量控制提供科学依据.方法:采用ICP-MS法对54批不同来源和级别(药用级和化工级)硬脂酸样品中的V、Co、Ni、Zn、As、Cd、Hg、Pb含量进行检测,并通过t检验、多元方差分析(MANOVA)和主成分分析(PCA)等统计方法进行数据分析.结果:大多数金属元素的残留量远低于ICH Q3D(R1)指南限值,但Zn、Cd、As、Pb和V在不同级别样品间存在显著差异(p＜0.05),尤其是Zn的浓度在化工级样品中显著高于药用级样品.结论:本研究建立了硬脂酸中多种金属元素的高灵敏度检测方法,揭示了不同级别和来源硬脂酸中金属元素残留的特征,为硬脂酸的质量控制、工艺改进和安全性评估提供了重要的科学依据.
Abstract
Objective:To systematically evaluate the residual levels of multiple metal elements in stearic acid from different sources and grades(pharmaceutical and industrial),explore the impact of production processes on these residues,and provide a scientific basis for quality control.Methods:The concentrations of V,Co,Ni,Zn,As,Cd,Hg,and Pb in 54 batches of stearic acid samples from various sources and grades(pharmaceutical and industrial)were detected using ICP-MS.Statistical analyses including t-tests,multivariate analysis of variance(MANOVA),and Principal Component Analysis(PCA)were employed to analyze the data.Results:The results indicated that most metal element residues were far below the ICH Q3D(R1)guideline limits.However,Zn,Cd,As,Pb,and V showed significant differences(p＜0.05)between different grade samples,with Zn concentrations notably higher in industrial grade samples compared to pharmaceutical grade samples.Conclusion:This study established a highly sensitive method for detecting multiple metal elements in stearic acid,revealed the characteristics of metal element residues in stearic acid of different grades and sources,and provided important scientific evidence for quality control,process improvement,and safety evaluation of stearic acid.
维普
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