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Particle size determination by automated microscopical imaging analysis with comparison to laser diffraction
1Pharmaceutical Quality Control and Assurance Hoffmann-LaRoche, Inc., Nutley, NJ 07110-1199, USA.
Journal of Pharmaceutical Sciences
|April 1, 1995
Summary
A new microscopy technique accurately determines particle size distribution. Results align well with laser diffraction, offering a reliable method for pharmaceutical analysis.
Area of Science:
- Materials Science
- Analytical Chemistry
- Pharmaceutical Sciences
Background:
- Accurate particle size distribution is crucial for pharmaceutical product performance and quality.
- Traditional methods may lack precision or speed for complex analyses.
- Microscopy offers direct visualization but requires robust quantification methods.
Purpose of the Study:
- To develop and validate a rapid, precise microscopical technique for particle size distribution analysis.
- To compare the microscopy-based method with established laser diffraction techniques.
- To assess the influence of crystalline shape on the accuracy of particle size determination.
Main Methods:
- Utilized a Carl Zeiss Axioplan microscope with a computer-controlled image analysis system.
- Performed area and volume measurements on individual particles.
- Generated distribution histograms by plotting measurements against Feret's diameter.
- Applied the technique to pharmaceutical compounds and compared results with laser diffraction data.
Main Results:
- The developed microscopical technique demonstrated good reproducibility.
- Histograms generated by microscopy showed good agreement with laser diffraction data.
- Agreement was found to be dependent on the crystalline shape of the analyzed particles.
Conclusions:
- Microscopy coupled with image analysis provides a rapid and precise method for particle size distribution determination.
- This technique is a viable alternative or complement to laser diffraction for pharmaceutical applications.
- Crystalline morphology significantly impacts the accuracy of particle size measurements, highlighting the need for shape consideration in analysis.