Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone

  • US 7,674,800 B2
  • Filed: 03/29/2007
  • Issued: 03/09/2010
  • Est. Priority Date: 03/30/2004
  • Status: Active Grant
First Claim
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1. A process for preparing an oxycodone salt substantially free of 14-hydroxycodeinone, which process comprises steps of:

  • (a) preparing a mixture of oxycodone free base, solvent and an acid, the oxycodone free base having an 8α

    ,14-dihydroxy-7,8-dihydrocodeinone component;

    (b) incubating the mixture under conditions suitable to convert the oxycodone free base to an oxycodone salt, wherein said conditions promote an acid catalyzed dehydration consisting of conversion of the 8α

    ,14-dihydroxy-7,8-dihydrocodeinone component to 14-hydroxycodeinone; and

    (c) preferentially removing the 14-hydroxycodeinone from the oxycodone salt.

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