Process for preparing form 1 ranitidine hydrochloride

US5663381A · kind A · utility

Assignee

• Hexal Pharmaceuticals, Inc. · US

Inventors

• Helmut Schickaneder · Eckental, DE
• Aggelos Nikolopoulos · Cork, IE

Key dates

• Filing date: Apr 21, 1995
• Grant date: Sep 2, 1997
• Expiry date: Apr 21, 2015

Classification

• Technology area (CPC A): Human Necessities
• CPC primary: A61P37/08
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

Abstract

A process for preparing pure N-[2-[[[5-[dimethylamino)-methyl-2-furanyl]methyl]thio]ethyl]-N'-methyl-2- nitro-1,1-ethyldiamine hydrochloride, designated Form 1 ranitidine hydrochloride, from ranitidine in methylene chloride with the addition of hydrochloric acid. The Form 1 ranitidine hydrochloride thus obtained is stable and therefore useful for producing commercial-scale quantities of Form 1 ranitidine hydrochloride.