<616> Bulk Density Of Powders

Type of Posting: Notice of Adoption of Harmonized Standard

Posting Date: 28-Apr-2023

Official Date: 1-May- 2024

Expert Committee: Excipients Test Methods

Coordinating Pharmacopoeia: European Pharmacopoeia

A revision 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 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:

  1. Changed the chapter title from "Bulk Density And Tapped Density Of Powders" to "Bulk Density Of Powders".
  2. Deleted the section heading, Bulk Density.
  3. Specified a new section heading, Untapped Bulk Density.
  4. Changed the Tapped Density section heading to Tapped Bulk Density.
  5. In Method 2—Measurement in a Volumeter in the Untapped Bulk Density section, changed the footnote for the apparatus from "ASTM B329–06(2012)" to “ISO 3923-2:1981 or ASTM B329-14". The dimensions accommodate both ISO and ASTM standards.
  6. In Method 1 in the Tapped Bulk Density section, deleted "either nominally 250 ± 15 taps from a height of 3 ± 0.2 mm, or" because this was defined in Method 2.
  7. General chapter <1174> is cross-referenced because it contains more information about MEASURES OF POWDER COMPRESSIBILITY.
  8. For consistency, replaced “weight” with “mass”, “material” with “powder”, and “cylinder/measuring cylinder” with “graduated cylinder” at the appropriate places throughout the chapter.
  9. Many description changes have been made to both the Untapped Bulk Density and Tapped Bulk Density sections.  

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 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).

Revision History

  • 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