Oxycodone Hydrochloride (Postponement)

Type of Posting: 
Notice of Intent to Revise
Reposting 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 Molecules 2 (SM2) Expert Committee intends to indefinitely postpone 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.

The postponement notice will be posted on September 30, 2010, and will become official on October 1, 2010.

The 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. 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.)