Skip to main content

Notice of Intent to Revise: Codeine Phosphate

Type of Posting: Notice of Intent to Revise
Posting Date: 26-Mar-2021
Targeted Official Date: 01-May-2021; Revision Bulletin
Expert Committee: Small Molecules 2

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to revise the Codeine Phosphate monograph.

The Expert Committee proposes to revise the acceptance criterion of codeine methyl ether from NMT 0.15% to NMT 0.45%, to accommodate Codeine Phosphate referenced in FDA approved products which have a different acceptance criterion of this impurity than the one in the monograph.

It is anticipated that the proposed revision will be published as Revision Bulletin on April 30, 2021 pursuant to the Rules and Procedures. 

Should you have any questions, please contact Wei Yang, Scientific Liaison (