PARTICLE SIZE ESTIMATION TECHNIQUES IN THE PHARMACEUTICAL INDUSTRY

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DOI: https://doi.org/None
Issue: 
3
Year: 
2017

E.S. Novik, PhD; A.V. Dorenskaya, PhD; N.A. Borisova; O.V. Gunar, PhD Research Center for Examination of Medical Products, Ministry of Health of the Russian Federation, Moscow, 8, Petrovsky Boulevard, Build. 2, Moscow 127051, Russian Federation

The paper considers the theoretical bases for determining the size of spherical and irregular-shaped particles used for their easier measurement. It is noted that various measurement techniques can yield different results. The paper analyzes the problems arising from the measurement of irregular-shaped particles. It briefly characterizes particle size determination techniques, such as sedimentation analysis, sieve analysis, microscopy, laser diffraction, light obscuration particle count test, and electrosensitive zone assay) and shows the advantages, disadvantages, and possibilities of their application in the pharmaceutical industry. It also highlights that there is a need to investigate the properties of the particles of dispersion materials, including pharmaceutical substances, in order to better understand the impact of these properties on the quality of the final product, its components and the regularities of manufacturing processes.
Keywords: 
particle size
quality analysis
techniques
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