Hydrochloric Acid → Fingolimod Hydrochloride

Participants

Reaction Steps

100.0 gm of fingolimod was dissolved in ethanol 250 ml and conc HCl 49 ml solutions. The reaction mass was stirred for about 30 min at room temperature; then concentrated under vacuum at about 40-45° C. 250 ml of ethanol was added. The reaction mass was heated to about 65-70° C. and 800 ml ethyl acetate was added in to reaction mass. The reaction mass was cooled to about 20-25° C. and stirred for about 30 min. The solid obtained was filtered and washed with ethyl, acetate to get 85 g of compound of Fingolimod hydrochloride. Purity 99.75% and Impurity compound of Formula XII: 0.06% by HPLC.

Provenance & Evidence