Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: 27-Sep-2024
Official Date: 01-Aug-2025
Expert Committee: Excipients Test Methods
Coordinating Pharmacopoeia: European Pharmacopoeia
A correction to the harmonized standard for <616> Bulk Density of Powders has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Rev. 4 correction 2 sign-off cover sheet. Having reached Stage 4 (former Stage 6) of the PDG process, the general chapter of <616> Bulk Density of Powders 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:
- Tapped bulk density section
- Title of Method 1 changed to: “Method 1 Measurement in a Graduated Cylinder – High Drop”
- Title of Method 2 changed to: “Method 2 Measurement in a Graduated Cylinder – Low Drop”
- Figure 3
- Inclusion of both drop heights as required by Method 1 and Method 2. The value is “14 ± 2 mm” or “3.0 ± 0.2 mm”
- Method 2: change of the value of the drop from “3” to “3.0”
Additionally, minor editorial changes have been made to update the chapter to current USP style.
General Chapter <616> Bulk Density of Powders will become official from August 1, 2025. Should you have any questions, please contact Dr. Tong (Jenny) Liu at (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 <616> Bulk Density of Powders – Stage 4
- Download the <616> Bulk Density of Powders PDG sign-off documents:
- June 18, 2024 , Rev. 4, Corr. 2
- Nov. 24, 2023 , Rev. 4, Corr. 1
- Jan. 20, 2023, Rev. 4
- Nov. 6, 2013, Rev.3
- June 15, 2011, Rev. 2
- June 10, 2009, Rev. 1, Corr. 1
- June 5, 2008, Rev. 1
- May 8, 2007
Revision History
- Previous Stage 4 (former Stage 6) web posting (posted 28-Apr-2023; official date: 01–May–2024)
- Previous Stage 6 web posting (posted 26-Sep-2014; official date: 01–Aug–2015)
- Previous Stage 6 (posted 23–Nov–2011; official Date: 01–Dec–2012)
- Previous Stage 6 posted in PF 36(5), 2010
- Previous Stage 6 posted in PF 35(3), 2009