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      Critical evaluation and guidance for using the Coulter method for counting subvisible particles in protein solutions.

      1 , ,
      Journal of pharmaceutical sciences
      Wiley

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          Abstract

          In this paper, we evaluate the suitability of Coulter method for detecting and quantifying subvisible particles in protein solutions and compare results with other particle-counting technologies. The effects of key instrument and operational parameters such as aperture diameter, solution conductivity, and cleaning procedures are demonstrated. Degraded and nondegraded intravenous immunoglobulin and human serum albumin were chosen as model proteins and sample types for this evaluation. Multisizer™4 was able to obtain reproducible and linear particle counts; however, customized analysis and cleaning procedures are needed depending on the protein analyzed and the sample type (degraded or nondegraded). The Coulter method consistently detected more particles than micro-flow imaging and light obscuration. The presence of translucent particles likely accounts for this observation because detection by the Coulter method does not depend on the optical properties of the particles or solution.

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          Author and article information

          Journal
          J Pharm Sci
          Journal of pharmaceutical sciences
          Wiley
          1520-6017
          0022-3549
          Jan 2012
          : 101
          : 1
          Affiliations
          [1 ] Department of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, University of Colorado Denver, Aurora, Colorado 80045, USA.
          Article
          S0022-3549(15)31753-6
          10.1002/jps.22732
          22109687
          8bb12073-f8c0-4786-b402-5a6a208742d0
          History

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