The sources of eight related substances in the crude product of cisatracurium besylate(1)were analyzed,and the related substances A,B,C,D,F,H,O included in EP and the non-pharmacopoeial impurity(6),named(1 R,2R)-1-(3,4-dimethoxybenzyl)-2-(3-ethoxy-3-oxo-propyl)-6,7-dimethoxy-2-methyl-1,2,3,4-tetrahydroisoquinolinium benzenesulfonate were synthesized by the acid hydrolysis and esterification with(1R,2R)-l-[(3,4-dimethoxyphenyl)methyl]-2-[3-(tert-butoxy)-3-oxy-propyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium benzenesulfonate(4)as the starting material.The structures of these compounds were confirmed by 1H NMR,13C NMR and HRMS analyses.Additionally,a crystallization process with obvious impurity removal effect and high yield was developed,which was suitable for indus-trial production.
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