Process for the preparation of oxymorphone alkaloid and oxymorphone salts

Abstract

The present invention provides a process for preparing an oxymorphone acid adduct, said process comprising hydrogenating an aqueous solution of 14-hydroxymorphinone and an acid to form a solution of the oxymorphone acid adduct, wherein the hydrogenation is carried out at one or more temperatures greater than 40° C. in the presence of a hydrogenation catalyst and hydrogen gas, wherein the level of 6α-oxymorphol produced is ≦3.00 area % as determined by HPLC.

1 . An aqueous solution of oxymorphone acid adduct comprising 6α-oxymorphol in an amount ≦about 3.00 area % as determined by HPLC. 
     
     
         2 . An aqueous solution according to  claim 1 , further comprising ≦about 50 ppm of an α,β-unsaturated ketone, preferably ≦about 25 ppm. 
     
     
         3 . Solid oxymorphone acid adduct comprising 6α-oxymorphol in an amount ≦about 3.00 area % as determined by HPLC. 
     
     
         4 . A solid oxymorphone acid adduct according to  claim 3 , further comprising ≦about 50 ppm of an α,β-unsaturated ketone, preferably ≦about 25 ppm. 
     
     
         5 . Solid oxymorphone alkaloid comprising 6α-oxymorphol in an amount ≦about 0.60 area % as determined by HPLC. 
     
     
         6 . A solid oxymorphone alkaloid according to  claim 5 , further comprising ≦about 50 ppm of an α,β-unsaturated ketone, preferably ≦about 25 ppm.