Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 25–Feb–2011

Official Date: 01–Dec–2011

Expert Committee: Monographs—Excipients

A harmonized standard for Povidone has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the Povidone monograph has been formally approved by the USP Monographs—Excipients Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Changes from the existing USP–NF monograph include:

  • Added statement to Definition on Nitrogen and K-value content.
  • Added Identification D test to ensure substance dissolves.
  • Changed Column packing from C8 to C18 in the Vinylpyrrolidinone test. Updated number of injections for System Suitability.
  • Added 2-Pyrrolidione, Peroxides, and Formic Acid tests.
  • Added two different pH ranges dependent upon K-value.

The Povidone monograph will be incorporated into and become official with the Second Supplement to USP 34–NF 29. Although the PDG process for Povidone took a significant amount of time to progress from publication at Stage 4 to Stage 6, any proposed changes must go through PDG and cannot be made unilaterally by USP in accordance with the PDG process and USP's Rules and Procedures of the Council of Experts.

Should you have any questions about the Povidone monograph, please contact Kevin Moore (301-816-8369 or ktm@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Mario Sindaco (301-816-8246 or mys@usp.org).