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Oxycodone Hydrochloride

Type of Posting: Revision Bulletin: POSTPONEMENT

Posting Date: 30–Sept–2010

Official Date: 01–Oct–2010

Expert Committee: Monographs—Small Molecules 2

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules2 (SM2) Expert Committee has indefinitely postponed Procedure 3: Limit of Oxycodone Related Compound A (14-Hydroxycodeinone and Oxycodone Related Compound C (Codeinone) of the Organic Impurities section of the Oxycodone Hydrochloride monograph. The purpose for the postponement is to have adequate time to evaluate and resolve potential impurity limit compliance issues that recently were brought to USP's attention.

This Oxycodone Hydrochloride Revision Bulletin supersedes the revision to Procedure 3: Limit of Oxycodone Related Compound A (14-Hydroxycodeinone and Oxycodone Related Compound C (Codeinone) of the Organic Impurities section that was published in USP 33–NF 28 Reissue and is scheduled to become official on October 1, 2010. Please note that Procedure 1: Limit of Alcohol and Procedure 2 are not affected by this postponement and will become official as scheduled on October 1, 2010.

Should you have any questions, please contact Clydewyn M. Anthony (301-816-8139 or cma@usp.org).