Isolation and characterization of a process impurity in tizanidine hydrochloride

盐酸替扎尼定工艺杂质的分离与鉴定

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Abstract

A new process impurity was detected during the HPLC analysis of Tizanidine hydrochloride (I) batches. The impurity (II) was isolated by preparative HPLC and characterized by NMR and Mass spectral analysis as 5-S-ethyl-N-(4,5-dihydro-1H-imidazol-2-yl)-2,1,3-benzothiadiazol-4-amine hydrochloride.

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