Quality control and product differentiation of LMWHs marketed in China using 1H NMR spectroscopy and chemometric tools
Journal of Pharmaceutical and Biomedical Analysis(2022)
摘要
•LMWHs marketed in China from different manufacturers studied by 1H NMR experiments and chemometric analysis.•The impurities and contaminants within all 80 batches of APIs were checked, the product uniformity was also assessed.•LMWHs can be differentiated in terms of their slightly different structure composition originated from production process.•The suitability of 1H NMR experiments combined with multivariate data model used as supervision standards was evaluated.
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关键词
Low molecular weight heparins,1H NMR,Multivariate models,Polysaccharides,Quality control
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