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

1. A process for preparing an oxycodone hydrochloride composition having less than 25 ppm 14-hydroxycodeinone comprising hydrogenating an oxycodone hydrochloride composition having at least 100 ppm 14-hydroxycodeinone in a suitable solvent to produce an oxycodone hydrochloride composition having less than 25 ppm 14-hydroxycodeinone.

2. The process of claim 1 , wherein said hydrogenation is performed with a hydrogen donor and a catalyst.

3. The process of claim 1 wherein said hydrogenation is performed under reflux.

4. The process of claim 1 , wherein the solvent is an alcohol.

5. The process of claim 4 , wherein the alcohol is selected from the group consisting of methanol, ethanol and isopropanol.

6. The process of claim 1 , further comprising recovering the oxycodone hydrochloride composition having less than 25 ppm 14-hydroxycodeinone from the solvent.

7. The process of claim 6 , wherein the recovery step comprises crystallizing the oxycodone hydrochloride composition having less than 25 ppm 14-hydroxycodeinone and filtering the crystallized composition from the solvent.

8. The process of claim 6 , comprising further hydrogenating the oxycodone hydrochloride composition having less than 25 ppm 14-hydroxycodeinone.

9. The process of claim 6 , wherein the oxycodone hydrochloride composition has a 14-hydroxycodeinone level of less than 15 ppm.

10. The process of claim 2 , wherein the hydrogenation is performed with a hydrogen donor.

11. The process of claim 10 , wherein the hydrogenation is further performed with a catalyst.

12. The process of claim 10 , wherein the hydrogen donor is selected from the group consisting of hydrogen gas, formic acid, indoline, cyclohexene, sodium borohydride, tetrahydroquinoline, 2,5-dihydrofuran, phosphoric acid, and combinations thereof.

13. The process of claim 1 , wherein the hydrogenation produces an oxycodone hydrochloride composition having a 14-hydroxycodeinone level of less than 15 ppm.

14. The process of claim 1 , wherein the hydrogenation produces an oxycodone hydrochloride composition having a 14-hydroxycodeinone level of less than 10 ppm.

15. The process of claim 1 , wherein the hydrogenation produces an oxycodone hydrochloride composition having a 14-hydroxycodeinone level of less than 5 ppm.

16. The process of claim 1 , wherein the hydrogenation produces an oxycodone composition having a 14-hydroxycodeinone level of between 15 ppm and 25 ppm, further comprising additional hydrogenation to produce an oxycodone hydrochloride composition comprising 14-hydroxycodeinone in an amount less than 10 ppm.

17. The process of claim 1 , wherein the hydrogenation produces an oxycodone composition having a 14-hydroxycodeinone level of between 10 ppm and 25 ppm, further comprising additional hydrogenation to produce an oxycodone hydrochloride composition comprising 14-hydroxycodeinone in an amount less than 5 ppm.

18. The process of claim 1 , wherein the hydrogenation step is performed without a hydrogen gas feed.