Powdered Cellulose

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 29-Apr-2022
Official Date: 01-May-2023
Expert Committee: Complex Excipients
Coordinating Pharmacopeia: European Pharmacopeia

A revision to the harmonized standard for Powdered Cellulose has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 4 of the PDG process, the Powdered Cellulose monograph has been formally approved by the USP Complex Excipients Expert Committee in accordance with the Rules and Procedures of the 2020–2025 Council of Experts.

Changes from the existing USP–NF monograph include:

  • In the beginning of the monograph, added the statement: “Portions of this monograph that are national USP text, and are not part of the harmonized text, are marked with symbols (⧫⧫) to specify this fact.”
  • Residue on Ignition
    • Specified the sample amount 1.0 g to align with the PDG sign-off document.
  • Loss on Drying
    • Specified the sample amount 1.0 g to align with the PDG sign-off document.
  • Microbial Limit test, Packaging and Storage, and Labeling
    • Added the symbols (⧫⧫) to indicate that they are non-harmonized attributes.
  • Additionally, minor editorial changes have been made to update the monograph to current USP style.

The Powdered Cellulose monograph will be incorporated into and become official with the USP-NF 2023 (May 1, 2023).

Should you have any questions about the Powdered Cellulose monograph, please contact Dr. 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).

The previous PDG sign-offs and Stage 4 postings are included as below: