Coordinating Pharmacopoeia: European Pharmacopoeia
A revision to the harmonized standard for Bulk Density and Tapped Density of Powders has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Rev. 3 sign-off cover sheet. Having reached Stage 6 of the PDG process, the general chapter of Bulk Density and Tapped Density of Powders 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:
Method II: Measurement in a Volumeter
- In the footnote for apparatus, changed from “ASTM 329 90” to “ASTM B 329-06(2012)”
- To be consistent with significant figures, changed from “The cup may be … cubical
(16.39 ± 0.2 mL)” to “The cup may be … cubical (16.39 ± 0.20 mL)”
- Added “If the difference between V500 and V1250 is less than or equal to 1 mL, V1250 is the tapped volume. If the difference between V500 and V1250 exceeds 1 mL, repeat in increments such as 1250 taps, until the difference between succeeding measurements is less than or equal to 1 mL.” before the last sentence.
General Chapter <616> Bulk Density and Tapped Density of Powders will be incorporated into and become official with the First Supplement to USP 38–NF 33.
Should you have any questions, please contact Kevin Moore (301-816-8369 or email@example.com). For any questions about the PDG and its processes, please see Pharmacopeial Harmonization Group or contact Richard Lew at (240-221-2060 or firstname.lastname@example.org).
- Download General Chapter <616> Bulk Density and Tapped Density of Powders –Stage 6
- Download the Bulk Density and Tapped Density of Powders PDG sign-off documents: