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Ezetimibe, a lipid-lowering drugs, is classified as selective cholesterol absorption inhibitor by blocking cholesterol absorption from the small intestine. Ezetimibe can be used alone or in combination with other hypolipidemic drugs for control the blood cholesterol levels. In the fiscal year 2018, Bureau of Drug and Narcotic held Quality Assurance of Medicine Program to survey the quality of Ezetimibe tablets. All samples were randomly sampling from public hospitals nationwide. Samples from importers were also collected by cooperating with Thai Food and Drug Administration. A total of 18 samples were obtained in strength of 10 milligrams from 2 foreign manufacturers (3 registration numbers). The samples were evaluated according to the United States Pharmacopeia (USP 40) for identification, assay, content uniformity, organic impurities and dissolution. The analytical method was verified prior to sample testing. The results showed that all samples complied with pharmacopeia specification. It can be concluded that the quality of Ezetimibe tablets in Thailand has satisfactory pharmaceutical characteristics.
Keywords: Ezetimibe / Quality Assurance of Medicine Program