<616> Bulk and Tapped Density

Type of Posting: 
Notice of Adoption of Harmonized Standard
Official Date: 
01–Dec–2012
Expert Committee: 
General Chapters—Physical Analysis

A harmonized standard for <616> Bulk and Tapped Density has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Sign-Off Cover Page. Having reached Stage 6 of the PDG process, the <616> Bulk and Tapped Density General Chapter has been formally approved by the USP General Chapters—Physical Analysis Expert Committee in accordance with the Rules and Procedures of the 2010–2015 Council of Experts.

Changes from the existing USP–NF General Chapter include:

  • Changed term “screen” to “sieve” to be consistent with sign off text. This change was made in two places, in 2nd paragraph under introductory paragraph on Bulk Density, and again at the Start of Method II.
  • Changed term “square” to “cubical” under Apparatus for Method II. Also added two decimal places for determination of dimensions in order to be consistent with the allowable error.
  • Added statement “or equal to” under Procedure for Method I in Tapped Density to account for differences of exactly 2 mL. 

The <616> Bulk and Tapped Density General Chapter will be incorporated into and become official with the Second Supplement to USP 35–NF 30.

Should you have any questions about the <616> Bulk and Tapped Density General Chapter, please contact Kevin Moore (301-816-8369 or ktm@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization Web page or contact Mario Sindaco (301-816-8246 or ktm@usp.org).