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Type of Posting: Notice of Intent to Revise

Posting Date: 09–Aug–2011

Expert Committee: Monographs—Excipients

In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Excipients Expert Committee intends to revise the Copovidone monograph to: 1) include an HPLC method for the Limit of Monomers to replace the titration method; and 2) include a Heavy Metals test based on the procedure and limit in the current EP monograph. The proposed Revision appears in PF 37(4).

Since the final monograph will need to be approved through Pharmacopeial Discussion Group (PDG), it is anticipated that the official monograph will be published on the Pharmacopeial Harmonization Web page as a Stage 6 revision at a date yet to be determined, pursuant to section 7.02 of the Rules and Procedures.

Should you have questions, please contact Kevin Moore, Scientific Liaison to the Expert Committee (301-816-8161 or