BRIEFING
〈786〉 Particle Size Distribution Estimation by Analytical Sieving. This proposal is based on the version of the chapter official as of May 1, 2023. The European Pharmacopoeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for this general test chapter, as part of the process of international harmonization of monographs and general analytical methods of the European, Indian, Japanese, and United States pharmacopeias. The following chapter, which represents the OFFICIAL INQUIRY STAGE 2 document, is based in part on the proposal for revision from the USP Physical Analysis Expert Committee as compiled from public inquiries concerning the chapter as well as advancements in the field and updates to other internationally recognized related standards. This is a harmonized chapter within the Pharmacopeial Discussion Group and the proposed revision is being published for public comments in all pharmacopeias. The revision will update the text to make it scientifically more rigorous.
Major revisions to this chapter include the following:
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Add a new Qualification subsection under Test Sieves to address the test sieves qualification in accordance with the current edition of ISO 3310-1.
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Revise section title from “Sieving Methods” to Analytical Sieving Methods.
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Revise subsection titles from "Mechanical Agitation" to Sieving by Mechanical Agitation and from “Air Entrainment Methods” to Sieving by Air Entrainment Methods.
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Revise all sections to improve clarity and incorporate new content.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
(MPPC: E. Biba)
Correspondence Number—C322707