Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 28-Apr-2023
Official Date: 1-May- 2024
Expert Committee: Excipient Test Methods
Coordinating Pharmacopeia: European Pharmacopoeia
A revision to the harmonized standard for <1174> Powder Flow has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Rev. 1 sign-off cover sheet. Having reached Stage 4 (former Stage 6) of the PDG process, the general chapter of <1174> Powder Flow has been formally approved by the USP Excipients Test Methods Expert Committee in accordance with the Rules and Procedures of the 2020-2025 Council of Experts.
Major changes from the existing USP–NF General Chapter include:
- In the beginning of the chapter, added the statement: "This general chapter has been harmonized with the corresponding texts of the European Pharmacopoeia and/or the Japanese Pharmacopoeia. Portions of this chapter that are national USP text, and are not part of the harmonized text, are marked with symbols (⧫⧫) to specify this fact."
- In the Compressibility Index and Hausner Ratio section, applied the terms of "untapped bulk density" and "tapped bulk density" to align with Bulk Density of Powders 〈616〉.
- In the Flow Through an Orifice section, introduced the term "arching diameter".
- Updated the Shear Cell Methods section, including major updates to the "Methods for Shear Cell" section. Added a reference to Shear Cell Methodology For Powder Flow Testing 〈1063〉, as a USP local text.
- For consistency, replaced “material(s)” with “powder(s)” at the appropriate places throughout the chapter.
- Many other description changes have been made in the chapter.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
General Chapter <1174> Powder Flow will become official from May 1, 2024.
Should you have any questions, please contact Dr. Tong (Jenny) Liu ((240) 221-2072 or jyl@usp.org). For any questions about the PDG and its processes, please see Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or rll@usp.org).
- Download General Chapter <1174> Powder Flow –Stage 4
- Download the <1174> Powder Flow PDG sign-off documents:
Revision History