Preparation and Characterization of an Process Impurity of Naphazoline Hydrochloride
This paper described the synthesis and refine of a process impurities N,N′-1,2-ethanediylbis-(1-Naphthaleneacetamide)(API-ZE),produced during the synthesis process of naphazoline hydrochloride.The target impurity(API-ZE)was synthesized with α-naphthaleneacetic acid(2)and ethylenediamine(3)as starting materials under high-temperature aminolysis.The target impurities structure was confirmed by 1H NMR,13C NMR,and HR-MS spectrum,and the purity is up to 99％(HPLC).The successful obtaining of the impurity makes the impurity study of naphthalazoline hydrochloride more comprehensive and in-depth,and provides a guarantee for its process amplification and quality control.
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