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Related Concept Videos

Precipitate Formation and Particle Size Control01:16

Precipitate Formation and Particle Size Control

In precipitation gravimetry, the precipitating agent should react specifically or selectively with the analyte. While a specific reagent reacts with the analyte alone, a selective reagent can react with a limited number of chemical species.
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In Vivo Alkaline Comet Assay and Enzyme-modified Alkaline Comet Assay for Measuring DNA Strand Breaks and Oxidative DNA Damage in Rat Liver
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Mastering particle size analysis: lessons, challenges, and future directions from the FDA-CRCG workshop.

Xiaoming Xu1, William C Smith1, James E Polli2

  • 1Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD 20993 USA.

AAPS Open
|April 23, 2026
PubMed
Summary

Accurate particle-size distribution (PSD) measurement is crucial for drug development. A workshop highlighted that reliable characterization requires fit-for-purpose design and transparency, not a single "true" size, improving regulatory confidence.

Keywords:
Center for Research on Complex Generics (CRCG) workshopColloidal dispersionComplex drug productsDynamic light scatteringFDAInter-laboratory comparabilityLaser diffractionMeasurement robustnessParticle size distributionRegulatory scienceSuspension

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Area of Science:

  • Pharmaceutical Sciences
  • Analytical Chemistry
  • Materials Science

Background:

  • Particle-size distribution (PSD) is critical for drug formulation, stability, and performance.
  • Existing methods for PSD measurement present significant scientific and practical complexities.
  • Standardized practices are needed to ensure reliable and comparable PSD data in pharmaceutical development.

Purpose of the Study:

  • To foster a shared understanding of PSD measurement principles and best practices.
  • To address the complexities in interpreting PSD data from different techniques.
  • To promote robust analytical procedures and data integrity in pharmaceutical quality assessment.

Main Methods:

  • A hybrid workshop co-hosted by the FDA and CRCG focused on Dynamic Light Scattering (DLS) and Laser Diffraction (LD).
  • Integrated scientific lectures, vendor demonstrations, and case-study discussions.
  • Pre-workshop characterization of diverse materials by participating vendors established a baseline.

Main Results:

  • Discussions emphasized that PSD data interpretation is context-dependent (model, sample, purpose).
  • Methodological transparency was deemed more important than pursuing a single 'true' particle size.
  • Key outcomes included identifying sources of inter-laboratory variability and agreeing on harmonized terminology and reporting.

Conclusions:

  • Reliable PSD characterization necessitates 'fit-for-purpose' analytical design and transparent reporting.
  • Improved comparability of PSD data across techniques and laboratories is essential for regulatory confidence.
  • Commitments were made to develop a community white paper and conduct an inter-laboratory study.