Contributing to the poster presentations at the 2009 AAPS Annual Meeting and Exposition (8-12 November 2009: Los Angeles, USA), researchers from Solvay Pharmaceuticals Inc and Malvern Panalytical will present details of a study to examine particle size, shape and distribution data for equivalency testing of a highly cohesive drug substance manufactured at two different sites.
Using Malvern Panalytical’s Morphologi G3 automated image analysis system for particle characterization, the team looked at the effects of different dispersion conditions including dispersion pressure, foil thickness, dispersion apparatus, and evaporative techniques. The results were compared with data from optical microscopy and laser light scattering methods. The authors go on to discuss the importance of method development in determining the techniques and parameters necessary to generate reproducible and accurate data. They highlight the usefulness of the Morphologi G3’s ability to selectively filter data, ensuring that analyses are performed only on the particles of interest.
Automated image analysis using the Morphologi G3 offers high resolution measurement of particle size and particle shape through direct image capture. It delivers excellent results for a wide range of particle sizes, typically from below 1 µm up to several thousand. It is ideal for many sample types including those, such as dry powders, creams and gels, and particles on filters, that may be difficult to characterize by other means.
The system will be demonstrated on the Malvern Panalytical Booth # 813, together with the latest Zetasizer systems for the measurement of proteins and nanosized particles, and Malvern Panalytical’s advanced range of Viscotek Gel Permeation/Size Exclusion chromatography systems for protein and polymer analysis. Visitors will be able to explore other systems in the Malvern Panalytical materials characterization range via interactive displays on the booth. Malvern Panalytical specialists will be available throughout to discuss individual material characterization needs. www.malvern.com
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