Structure of New Related Impurities of Dioxidine Substance
摘要
Abstract
Identification and quantification of typical related impurities is important to evaluate the purity of an active pharmaceutical substance. Three new related impurities of dioxidine have previously been discovered. In this work, a complex of physicochemical methods (IR-, UV-, NMR-spectroscopy and mass spectrometry) was used to determine the structures of these impurities. We have found conditions for the synthesis of new dioxidine impurities and have analyzed their solubility in the media, which are most often used in chromatographic analysis.