Sodium Hydroxide → Pantoprazole sodium (USP)

Participants

Reaction Conditions

Reaction Steps

Pantoprazole free base (50 grams) was dissolved in a solution of tetrahydrofuran (350 ml) and aqueous sodium hydroxide solution (5.4 grams dissolved in 10 ml of water), and stirred at a temperature of 25-35° C. till the clear solution results. The reaction solution was filtered through hyflow and washed the bed with tetrahydrofuran (2×25 ml). Dichloromethane (400 ml) was added slowly to the filtrate over a period of about 1 hour and stirred for about 5-6 hours to crystallize the solid mass. The separated solid mass was cooled to a temperature of 5-10° C. and further stirred for about 2-3 hours. The solid was filtered, washed with dichloromethane (2×25 ml) and suck dried under vacuum. The wet solid was suspended in dichloromethane (250 ml) and stirred for about 15-30 minutes. Then the solid was filtered and suck dried under vacuum and further dried at a temperature of 40-50° C. to afford crystalline Form-I of Pantoprazole sodium sesquihydrate.

Provenance & Evidence