Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
In certain embodiments the invention is directed to a process for preparing an oxycodone hydrochloride composition having less than 25 ppm of 14-hydroxycodeinone.
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 8α,14-dihydroxy-7,8-dihydrocodeinone.
2. The oxycodone hydrochloride active pharmaceutical ingredient of claim 1 , wherein the 14-hydroxycodeinone is derived solely from the 8α, 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.