A process for preparing epinastine hydrochloride of formula (I) the process comprising: (a) suspending and dissolving an epinastine base of formula (II)  in water by the addition of aqueous hydrochloric acid at a pH of ≧7; (b) extracting the aqueous solution obtained from step (a) with an organic, water-immiscible solvent; (c) removing the organic, water-immiscible solvent from the aqueous solution obtained from step (b); and (d) adjusting the pH of the aqueous solution of step (c) to ≦6 using hydrochloric acid to precipitate the product of formula (I), and then drying the product.