Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone

摘要

PROCESS FOR PREPARING AN OXYCODONE HYDROCHLORIDE HAVING LESS THAN 25 PPM 14-HYDROXYCODEINONE Abstract In one or more embodiments the invention relates to a process for preparing an 5 oxycodone salt composition having less than 25 ppm 14-hydroxycodeinone, which process comprises the steps of: (a) providing an oxycodone base composition, said oxycodone base composition comprising an amount of 8a, 14-dihydroxy-7,8-dihydrocodeinone; (b) reacting said oxycodone base composition with an acid under conditions 10 suitable to convert the oxycodone base composition to an oxycodone salt composition and to promote an acid catalysed dehydration of 8a, 14-dihydroxy-7,8-dihydrocodeinone to 14-hydroxycodeinione; and (c) reducing an amount of 14-hydroxycodeinone in the oxycodone salt composition formed in step (b) to produce an oxycodone salt composition having less 15 than 25 ppm 14-hydroxycodeinone.