PROCESS FOR PREPARING OXYCODONE COMPOSITIONS
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 - 79 . (canceled)
80 . A process for preparing an oxycodone composition comprising:
subjecting a first oxycodone composition comprising a first amount of 14-hydroxycodeinone to chromatographic separation to preferentially remove 14-hydroxycodeinone as compared to oxycodone; and
recovering a second oxycodone composition comprising a second amount of 14-hydroxycodeinone;
wherein the second amount of 14-hydroxycodeinone is lower than the first amount of 14-hydroxycodeinone.
81 . The process of claim 80 , wherein the second amount is less than 100 ppm.
82 . The process of claim 81 , wherein the second amount is less than 25 ppm.
83 . The process of claim 82 , wherein the second amount is less than 10 ppm.
84 . The process of claim 83 , wherein the second amount is less than 5 ppm.
85 . The process of claim 81 , wherein the second amount is 0.25 ppm or more.
86 . The process of claim 85 , wherein the second amount is 1 ppm or more.
87 . The process of claim 80 , wherein the chromatographic separation is a simulated moving bed.
88 . The process of claim 80 , wherein the process is for preparing an oxycodone hydrochloride composition.
89 . The process of claim 80 , wherein the process is for preparing an oxycodone hydrochloride active pharmaceutical ingredient composition.
90 . The process of claim 80 , wherein the process is for preparing an oxycodone hydrochloride active pharmaceutical ingredient composition comprising less than 25 ppm 14-hydroxycodeinone.