THIẾT LẬP CHẤT ĐỐI CHIẾU 4-(OXIRAN-2-YLMETHOXY)-9 H-CARBAZOL (TẠP D) VÀ 2-(2-METHOXYPHENOXYL)ETHYLAMIN (TẠP E) CỦA CARVEDILOL 

Summary

4-(oxiran-2-ylmethoxy)-9H-carbazol (carvedilol impurity D) and 2-(2-methoxyphenoxyl)ethylamine (carvedilol impurity E) were established as reference standards, basing on the ISO guide. Results showed that the units (vials) were homogeneous in the process of packaging and the chromatographic purity of D and E impurities are 99.96 % and 99.77 %, respectively, with the uncertainties from 0 to 0.00294.

Keywords: Carvedilol impurity, 4-(oxiran-2-ylmethoxy)-9H-carbazole, 2-(2-methoxyphenoxyl) ethylamine.

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