<786> Analytical Sieving

Type of Posting: Notice of Adoption of Harmonized Standard
Posting Date: April 29, 2022
Official Date: May 1, 2023
Expert Committee: General Chapters–Physical Analysis Expert Committee (GCPA)
Coordinating Pharmacopeia: European Pharmacopeia

The revision to the harmonized standard for <786> Particle Size Distribution Estimation by Analytical Sieving has been approved by the Pharmacopeial Discussion Group (PDG) as described in its PDG Stage 4 sign-off cover sheet. The chapter has been formally approved by the General Chapters–Physical Analysis Expert Committee in accordance with the Rules and Procedures of the Council of Experts.

The changes from the current version of the chapter are:

  • In the beginning of the monograph, added the statement: “Portions of this monograph that are national USP text, and are not part of the harmonized text, are marked with symbols  to specify this fact.”
  • Test Sieves
    • Editorial changes are made in the first paragraph.
  • Test Specimen
    • Editorial changes are made.
    • The 203-mm (8-inch) and 75-mm (3-inch) sieves were added in addition to the 200-mm and 76-mm.
  • Endpoint Determination
    • The 75-mm sieve is added in the text.

The <786> general chapter will be incorporated into and become official with the USP-NF 2023 (May 1, 2023).

Should you have any questions about this General Chapter, please contact Edmond Biba (301-230-3276 or exb@usp.org). For any questions about the PDG and its processes, please see the Pharmacopeial Harmonization website or contact Richard Lew at (240-221-2060 or rll@usp.org).

The previous PDG sign-offs and Stage 4 postings are included as below: