Preparation of form 1 ranitidine hydrochloride

Details Preparation of form 1 ranitidine hydrochloride Preparation of form 1 ranitidine hydrochloride

C - Chemistry, Metallurgy

07

D

C07D 307/52 (2006.01)

Patent

CA 2099530

Pure Form 1 ranitidine hydrochloride is prepared by a process of crystallization from a solution of ranitidine hydrochloride in a mixed solvent comprising 1 part by volume of at least one lower alkanol such as ethanol and 1 - 2.0 parts by volume of a C6 - C10 aromatic hydrocarbon such as toluene, and in the presence of seed crystals of pure Form 1 ranitidine hydrochloride. In the preferred process according to the invention, the ranitidine hydrochloride is prepared in situ in the solvent mixture by adding hydrochloric acid to a solution of the free base in the solvent mixture, in the presence of the seed crystals.

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