• Corpus ID: 26186979

Validation and Robustness Testing of an Enantioselective CE Method for Chemical Quality Control

@inproceedings{JimidarValidationAR,
  title={Validation and Robustness Testing of an Enantioselective CE Method for Chemical Quality Control},
  author={M. Ilias Jimidar and Willy Van Ael and Maurits De Smet}
}
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Capillary electrophoresis for pharmaceutical analysis.

The areas of pharmaceutical analysis covered are enantiomer separation, analysis of small molecules such as amino acids or drug counter-ions, pharmaceutical assay, related substances determinations, and physiochemical measurements such as log P and pKa of compounds.

ВАЛИДАЦИЯ ХРОМАТОГРАФИЧЕСКИХ МЕТОДИК: ИССЛЕДОВАНИЕ РОБАСТНОСТИ С ИСПОЛЬЗОВАНИЕМ МАТЕМАТИЧЕСКОГО ПЛАНИРОВАНИЯ ЭКСПЕРИМЕНТОВ

The theoretical and practical basics of research of the robustness of chromatographic methods on the base of Plackett - Burman design are covered and the recommendations for performing necessary calculations in Excel and for the assessment of robustness are suggested.

The Role of the Robustness/Ruggedness and Inertia Studies in Research and Development of Analytical Processes

The denomination of “inertia study” is introduced to designate this methodology in extrinsic validation and precision and trueness tests are proposed inside the inertia study.