Patent ID: 9732030
Date: 2017-08-15
CPC Classifications: C07B,C07C

Claim:
1. A process for preparing Fingolimod hydrochloride (I), comprising the steps of— a) providing a solution of Fingolimod base with an ester or a halohydrocarbon organic solvent used in the range up to more than 20 times (by volume) but less than 50 times (by volume) with respect to weight of Fingolimod free base; b) raising the temperature to a range between 35 to 75° C.; c) optionally adding activated carbon followed by filtering; d) adding 5-10% isopropanol-hydrochloric acid solution; and e) isolating the Fingolimod hydrochloride crystalline Form-β; the said crystalline Form-β being characterized by x-ray powder diffraction pattern having, characteristic 2θ° peaks in XRPD peak set of 3.54, 7.10, 10.67, 15.36, 17.83, 20.53, 21.49, 23.29, 25.12, 26.68 and 29.22±0.1 2θ°; un-split peak near at 20.5 2θ° and DSC isotherm comprising endothermic peaks selected from peak-1: ranging between 40 to 45° C., peak-2: ranging between 65 to 70° C. and peak-3: ranging between 107 to 115° C.