Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 27–Apr–2018

Official Date: 01–May–2019

Expert Committee: Excipient Monographs 2

Coordinating Pharmacopeia: Japanese Pharmacopoeia

The revision to the harmonized standard for Povidone has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG sign-off cover sheet. Having reached Stage 4 (former Stage 6) of the PDG process, the Povidone monograph has been formally approved by the Excipient Monographs 2 Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

Changes from the current Povidone monograph include as below: 

  • Assay 
    • Adopted the experimental procedure according to the PDG sign-off document. The sign-off procedure employs the same principle as that in <461> for Nitrogen Determination, but has a few differences in the use of reagents, volume and indicator, etc. The revision proposal was published in the PF 43(2) for public comments and did not receive any comments on this adoption.
  • Limit of Aldehydes
    • Clarified that the concentration of Sample solution is “calculated on the anhydrous basis”.
  • Limit of Hydrazine
    • In Analysis, move the phrase “Locate the spots on the plate by examination under UV light.” to the end of the procedure because this step occurs after removing the plate from the chamber.
  • Formic Acid
    • The recommended HPLC Column for analysis is “7.9-mm X 30-cm, 10-µm, packing L17”, based on the availability of the column on the market. Other L17 columns can be used if the suitability has been demonstrated in the method qualification. 

Additionally, the monograph has been edited to be consistent with the current USP style.

The Povidone monograph will be incorporated into and become official with the USP 42–NF 37.

Should you have any questions about the Povidone monograph, please contact Tong (Jenny) Liu (240-221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).