Povidone

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 20–Nov–2015

Official Date: 01–Dec–2016

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 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 existing USP–NF monograph include:

  • Chemical information
    • Added another chemical name for povidone.
  • Definition
    • Changed the verbiage according to PDG sign-off document.
  • Limit of Aldehyde
    • Used acetaldehyde ammonia trimer trihydrate instead of acetaldehyde for preparing the Standard solution. The calculation of CS was adjusted accordingly.
    • The Sample solution was changed from “20 mg/mL” to “10 mg/mL.”
    • Clarified that water was used as the reference when determining the UV absorbance.  The cell with water for reaction was used for blank test.
  • Limit of Hydrazine
    • Changed Standard solution concentration from “9.38 µg/mL” to 9 µg/mL.”
    • Added description to silica gel plate “with fluorescent indicator.”
  • Vinylpyrrolidinone
    • Changed mobile phase from “Methanol and water (1:4)” to “Water and Acetonitrile (90:10).”
    • Used mobile phase as a diluent for the Standard stock solution, Standard solution, and Sample solution.
    • Changed the inner diameter and length for both guard column and analytical column.
    • Changed injection volume from “50 µL” to “20 µL.”
    • Added the Flow rate of 1.0 mL/min.
    • Deleted the note for adjusting flow rate and the note for column back flushing.
    • Added “calculated on the anhydrous basis” to Cu (concentration of Povidone in Sample solution).
  • 2-Pyrrolidone
    • Changed mobile phase from “Water adjusted with phosphoric acid to a pH of 2.4” to “Water and methanol (19:1).”
    • Used mobile phase as diluent in the Standard solution and Sample solution.
    • Changed the inner diameter and length for both guard column and analytical column.
    • Changed the column temperature from “30°” to “40°.”
    • Added the flow rate of 0.8 mL/min and the approximate retention time of 2-Pyrrolidone.
    • Deleted the note for adjusting flow rate and the note for column back flushing.
    • Added additional system suitability requirements for theoretical plate number and symmetry factor.
  • Formic Acid
    • Changed mobile phase from “Diluted perchloric acid (5 in 1000)” to “Diluted perchloric acid (1 in 700).”
    • Changed the description of column in terms of inner diameter and length
    • Changed the Column temperature from “30°” to “35°.”
    • Added the Flow rate of 1.0 mL/min and the approximate retention time of formic acid. Deleted the note for adjusting flow rate.
    • Added additional system suitability requirements for theoretical plate number and symmetry factor.
  • K-value
  • Modified the description of test in accordance with PDG sign-off document.
  • Added the symbols to Lead, which is a local requirement. Deleted the symbols from Labeling, because it is a harmonized attribute.

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 Second Supplement to USP 39–NF 34.

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).