Systematic Evaluation of Multiple Metal Element Residues in Pharmaceutical Grade Stearic Acid and Quality Control Strategy Research
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.
stearic Acidmetal element residuespharmaceutical excipientsquality controlICP-MS
万方数据
维普
