Transcription of Robustness/ruggedness tests in method validation
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Robustness/ruggedness tests in method validation
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.
of chromatographic (liquid, gas or thin-layer chromatography) or electrophoretic methods. The list is not exhaustive, but gives the reader an idea of the factors commonly examined. If a sample preparation procedure (liquid-liquid extraction, solid-liquid extraction,
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