A Novel And Easily Scalable, Improved Manufacturing Process For The Preparation Of Isosulfan Blue

Abstract: The present invention relates to a novel and easily scalable synthesis, process for the preparation of pure Isosulfan blue i.e., N-[4-[[4-(Diethyl amino) phenyl](2,5-disulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene] -N-ethyl ethanamimium inner sodium salt via two process raw materials viz., 4-Chloro-3-formylbenzenesulfonic acid, compound of formula I and diethylaniline. In the present invention yield of the reactions using two key starting materials is drastically increased by retaining the same impurity profile and by performing incremental addition of sodium hydroxide solution at 100-105°C and maintaining the reaction mixture at high temperature till reaction completion. The use of adding sodium hydroxide solutions in increments reduces the number of batches and increases the yield of the product. In the method of present invention highly pure Isosulfan blue (99.5%) is obtained with improved yield (40-60%).

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