OXYMORPHONE CHLORIDE PRODUCT, PHARMACEUTICAL FORMULATION, METHOD FOR PURIFYING OXYMORPHONE CHLORIDE, AND OXYMORPHONE CHLORIDE PRODUCT

摘要

Improved analgesic oxymorphone hydrochloride contains less than 10 ppm of alpha, beta unsaturated ketones and pharmaceutical preparations comprising such oxymorphone hydrochloride. The oxymorphone hydrochloride is produced by reducing a starting material oxymorphone hydrochloride using gaseous hydrogen and under specified acidity, solvent system and temperature conditions. A specific polymorph of oxymorphone hydrochloride may be obtained by hydration.