BRIEFING
〈429〉 Light Diffraction Measurement of Particle Size. This proposal is based on the version of the chapter official prior to 2013. The European Pharmacopoeia is the coordinating pharmacopeia for the international harmonization of this general test chapter, as part of the process of international harmonization of the analytical methods of monographs and general chapters of the European, Japanese, and United States pharmacopeias. The following represents the OFFICIAL INQUIRY STAGE 2 document. It 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 the three pharmacopeias.
A summary of the major revisions to this chapter is as follows:
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Change the chapter title to "〈429〉 Particle Size Analysis by Laser Light Diffraction".
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A figure is added to illustrate optical arrangements in laser light diffraction instrument.
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Change the section title "Development of the Method" to "Development of the Procedure", and clarify the scope and acceptance criteria.
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Revise the Measurement section to add precautions and clarifications.
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Change the section title "Control of Instrument" to "Instrument Qualification", and substantially revise the section content.
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Change the section title "Qualification of the System" to "Performance Qualification", and add clarification to the section content.
Additionally, minor editorial changes have been made to update the chapter to current USP style.
(GCPA: E. Biba)
Correspondence Number—C173675