| abstract |
The invention relates to a solid crystalline ondansetron having at least one of the following characteristics: a melting endotherm peak greater than or equal to 240°C; a trace amount of a base or residue thereof comprising an alkali metal, an amine, an ammonium or an ion thereof; or a water content of 1.3 to 1.5 wt%, and to a composition comprising same and a pharmaceutically acceptable excipient, and to a process, which comprises: neutralizing an acid addition salt of ondansetron to liberate ondansetron free base; and precipitating said ondansetron free base from a liquid media, and to a process, which comprises dissolving ondansetron free base in a solvent and precipitating said dissolved ondansetron free base to form ondansetron having a melting endotherm peak of greater than or equal to 240°C measured on DSC at 5°C/min. |