Details for Patent: 7,683,072
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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) |
Filing Date: | Jan 16, 2007 |
Application Number: | 11/653,529 |
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. |