Sodium Hydroxide → Pantoprazole sodium (USP)

Participants

Reaction Conditions

Reaction Steps

Pantoprazole free base (25 grams) was dissolved in a solution of acetonitrile (175 ml) and aqueous sodium hydroxide solution (2.7 grams in 5 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 acetonitrile (25 ml). Isopropyl ether (225 ml) was added slowly to the filtrate over a period of about ½ hour and the filtrate was stirred for about 1-2 hours to crystallize the solid mass. The separated solid mass was cooled to a temperature of 5-10° C. and further stirred for 3-4 hours. The solid was filtered, washed with Isopropyl ether (25 ml) and suck dried under vacuum. The wet solid was further dried at a temperature of 40-50° C. to afford crystalline Form-I of Pantoprazole sodium sesquihydrate.

Provenance & Evidence