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, wherein the aqueous solution is a post-hydrogenation liquor. 
     
     
         2 . The aqueous solution according to  claim 1 , further comprising ≤ about 50 ppm of an α,β-unsaturated ketone. 
     
     
         3 . A crude solid oxymorphone acid adduct comprising 6α-oxymorphol in an amount ≤ about 3.00 area % as determined by HPLC. 
     
     
         4 . The crude solid oxymorphone acid adduct according to  claim 3 , further comprising ≤ about 50 ppm of an α,β-unsaturated ketone. 
     
     
         5 . The aqueous solution according to  claim 2 , further comprising ≤ about 25 ppm of an α,β-unsaturated ketone. 
     
     
         6 . The crude solid oxymorphone acid adduct according to  claim 4 , further comprising ≤ about 25 ppm of an α,β-unsaturated ketone.