Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation, which ensures that quality is built in to the analytical method from the beginning avoiding quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affects the analytical life-cycle of the developed method. It provides a robust and flexible operable range for an analytical method with greater excellence and regulatory compliance. The book will cover sample preparation problems and usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve them by optimization of the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS, electrophoresis. The book also covers the use of spectroscopic or spectrometry data, some of which require multivariate statistical analyses. Handbook of Analytical Quality by Design will be useful for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic conceptCovers key aspects of analytical development and validationProvides a robust and flexible operable range for an analytical method with greater excellence and regulatory compliance INDICE: 1. Introduction to analytical quality by design2. Analytical Quality by Design for spectrophotometric method development3. Analytical Quality by Design for liquid chromatographic method development4. Analytical Quality by Design for gas chromatographic method development5. Analytical Quality by Design for size-exclusion chromatography6. Analytical Quality by Design for ion-exchange chromatography7. Analytical Quality by Design for LC-MS/MS method development8. Analytical Quality by Design for HPTLC method development9. Analytical Quality by Design for capillary electrophoresis10. Quality by Design based development of vibrational spectroscopy methods11. Quality by Design based development of atomic absorption spectroscopy methods12. Quality by Design based development of non-destructive analytical techniques  13. Design space considerations for flexibility in analytical method development

• ISBN: 978-0-12-820332-3
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 270
• Fecha Publicación: 01/11/2020
• Nº Volúmenes: 1
• Idioma: Inglés