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Method Validation

  • Chapter
Analysis of Pharmaceuticals by Capillary Electrophoresis

Part of the book series: Chromatographia CE Series ((CHROM,volume 2))

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Abstract

Method validation is a necessary exercise in which the method under assessment is proven to be “fit for purpose”. The experiments follow a predetermined protocol and the results must meet predetermined criteria of performance. The exact experiments conducted are dependent on the type of testing being undertaken and the extent of the method’s usage. Table 11.1 gives some examples of validation studies in CE, detailing the validation aspects studied in the individual studies (1–20). Each of these validation aspects are then discussed in this chapter.

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Authors and Affiliations

  1. Pharmaceutical Development, Glaxo Wellcome R&D, Park Road, Ware, Herts., SG12 ODP, UK

    Kevin D. Altria

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  1. Kevin D. Altria
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© 1998 Friedr. Vieweg & Sohn Verlagsgesellschaft mbH, Braunschweig/Wiesbaden

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Altria, K.D. (1998). Method Validation. In: Analysis of Pharmaceuticals by Capillary Electrophoresis. Chromatographia CE Series, vol 2. Vieweg+Teubner Verlag. https://doi.org/10.1007/978-3-322-85011-9_11

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  • DOI: https://doi.org/10.1007/978-3-322-85011-9_11

  • Publisher Name: Vieweg+Teubner Verlag

  • Print ISBN: 978-3-322-85013-3

  • Online ISBN: 978-3-322-85011-9

  • eBook Packages: Springer Book Archive

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