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Claims for Patent: 7,683,072

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Claims for Patent: 7,683,072

Title:Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Abstract:In certain embodiments the invention is directed to a process for preparing an oxycodone hydrochloride composition having less than 25 ppm of 14-hydroxycodeinone.
Inventor(s): Chapman; Robert (North Kingstown, RI), Rider; Lonn S. (Foster, RI), Hong; Qi (Sharon, MA), Kyle; Donald (Newtown, PA), Kupper; Robert (Coventry, RI)
Assignee: Purdue Pharma L.P. (Stamford, CT)
Application Number:11/653,529
Patent Claims: 1. An oxycodone hydrochloride active pharmaceutical ingredient having less than 25 ppm 14-hydroxycodeinone, wherein at least a portion of the 14:hydroxycodeinone is derived from 8.alpha.,14-dihydroxy-7,8-dihydrocodeinone.

2. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1, wherein the 14-hydroxycodeinone is derived solely from the 8.alpha., 14-dihydroxy-7,8-dihydrocodeinone.

3. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 5 ppm 14-hydroxycodeinone.

4. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 15 ppm 14-hydroxycodeinone.

5. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 10 ppm 14-hydroxycodeinone.

6. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 0.25 ppm 14-hydroxycodeinone.

7. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 0.25 ppm.

8. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 0.5 ppm.

9. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 1 ppm.

10. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 2 ppm.

11. The oxycodone hydrochloride active pharmaceutical ingredient of claim 4, having a lower limit of 14-hydroxycodeinone of 5 ppm.

12. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 2 ppm 14-hydroxycodeinone.

13. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 1 ppm 14-hydroxycodeinone.

14. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 having less than 0.5 ppm 14-hydroxycodeinone.
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