Processes For Preparing Morphinan-6-One Products With Low Levels Of Alpha, Beta-Unsaturated Ketone Compounds

Abstract

The present invention generally relates to processes for preparing highly pure morphinan-6-one products. The processes involve reducing the concentration of alpha, beta unsaturated ketone compounds present as impurities in morphinan 6 one products or reaction mixtures including morphinan 6 one compounds by treatment with a sulfur-containing compound.

1 .- 50 . (canceled) 
     
     
         51 . A composition comprising oxymorphone and containing about 0.001% or less, by weight of said oxymorphone, of an α,β unsaturated ketone. 
     
     
         52 . The composition of  claim 51  wherein said α,β unsaturated ketone is 14-hydroxymorphinone or 14-hydroxycodienone. 
     
     
         53 . The composition of  claim 51  wherein said α,β unsaturated ketone is 14-hydroxymorphinone. 
     
     
         54 . The composition of  claim 51  wherein said α,β unsaturated ketone is 14-hydroxymorphinone or 14-hydroxycodienone and no 14-hydroxymorphinone or 14-hydroxycodienone is detectable by high performance liquid chromatography with mass spectrometry detection. 
     
     
         55 . The composition of  claim 51  wherein said α,β unsaturated ketone is 14-hydroxymorphinone and said composition comprises about 0.0005% or less, by weight of said oxymorphone, of 14-hydroxymorphinone. 
     
     
         56 . The composition of  claim 51  wherein said α,β unsaturated ketone is 14-hydroxymorphinone or 14-hydroxycodienone and said composition comprises about 0.0005% or less, by weight of said oxymorphone, of 14-hydroxymorphinone or 14-hydroxycodienone. 
     
     
         57 . The composition of  claim 51 , wherein the oxymorphone is an oxymorphone salt. 
     
     
         58 . The composition of  claim 53 , wherein the oxymorphone is an oxymorphone salt. 
     
     
         59 . The composition of  claim 55 , wherein the oxymorphone is an oxymorphone salt. 
     
     
         60 . The composition of  claim 51 , wherein the oxymorphone is oxymorphone HCl. 
     
     
         61 . The composition of  claim 53 , wherein the oxymorphone is oxymorphone HCl. 
     
     
         62 . The composition of  claim 55 , wherein the oxymorphone is oxymorphone HCl. 
     
     
         63 . A pharmaceutical formulation comprising oxymorphone and containing about 0.001% or less, by weight of said oxymorphone, of an α,β unsaturated ketone. 
     
     
         64 . The pharmaceutical composition of  claim 63  wherein said α,β unsaturated ketone is 14-hydroxymorphinone or 14-hydroxycodienone. 
     
     
         65 . The pharmaceutical composition of  claim 63  wherein said α,β unsaturated ketone is 14-hydroxymorphinone. 
     
     
         66 . The pharmaceutical composition of  claim 63  comprising about 0.0005% or less, by weight of said oxymorphone, of an α,β unsaturated ketone. 
     
     
         67 . The pharmaceutical composition of  claim 63  comprising about 0.0005% or less, by weight of said oxymorphone, of 14-hydroxymorphinone. 
     
     
         68 . The pharmaceutical composition of  claim 63  wherein said oxymorphone is oxymorphone HCl. 
     
     
         69 . The pharmaceutical composition of  claim 65  wherein said oxymorphone is oxymorphone HCl. 
     
     
         70 . The pharmaceutical composition of  claim 67  wherein said oxymorphone is oxymorphone HCl.