Preparation procedure for oxycodone hydrochloride having less than 25 ppm of 14-hydroxycodeinone

2005 
A process for preparing an oxycodone hydrochloride composition having a level of 14-hydroxycodeinone in an amount of less than 25 ppm as determined by the HPLC method of Example 6, which comprises reacting in a suitable solvent a base composition of Oxycodone having an amount of 8,14-dihydroxy-7,8-dihydrocodeinone with hydrochloric acid in an amount greater than 1.0 molar equivalent compared to the oxycodone base composition, whereby 8,14-dihydroxy 7 , 8-dihydrocodeinone is dehydrated to 14-hydroxycodeinone, and under reducing conditions provided by a catalyst and a hydrogen donor, whereby 14-hydroxycodeinone is converted to oxycodone, in which the solvent is selected from the group consisting of water, an alcohol, an ether, an amide, N-methylpyrrolidone, a carboxylic acid, and an appropriate mixture of any of two or more of the solvents mentioned above.
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