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Robustness/ruggedness tests in method validation - VUB

27/03/06. Guidance for Robustness/ruggedness tests in method validation Y. Vander Heydena, , J. Smeyers-Verbekea, Vandeginsteb and Massarta aVrije Universiteit Brussel, ChemoAC, Pharmaceutical Institute, Laarbeeklaan 103, 1090 Brussel, Belgium bUnilever Research Vlaardingen, Box 114, 3130 AC Vlaardingen, The Netherlands Content 1. Introduction Definitions Situating robustness in method development and validation Objectives of a robustness evaluation The steps in a robustness test 2. Selection of factors and levels Selection of the factors Mixture-related factors Quantitative factors Qualitative factors Selection of the factor levels Quantitative and mixture factors Asymmetric intervals for quantitative factors Qualitative factors 3.

1.2 Situating robustness in method development and validation 1.3 Objectives of a robustness evaluation 1.4 The steps in a robustness test 2. Selection of factors and levels 2.1. Selection of the factors ... In HPLC analysis the mobile phase can contain, besides the aqueous phase, one to three organic modifiers, yielding mixtures of two to four ...

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  Development, Validation, Hplc, Development and validation, Robustness

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