Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis.
This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields.
Les mer
1. Introduction to analytical quality by design
2. Analytical Quality by Design for spectrophotometric method development
3. Analytical Quality by Design for liquid chromatographic method development
4. Analytical Quality by Design for gas chromatographic method development
5. Analytical Quality by Design for size-exclusion chromatography
6. Analytical Quality by Design for ion-exchange chromatography
7. Analytical Quality by Design for LC-MS/MS method development
8. Analytical Quality by Design for HPTLC method development
9. Analytical Quality by Design for capillary electrophoresis
10. Quality by Design based development of vibrational spectroscopy methods
11. Quality by Design based development of atomic absorption spectroscopy methods
12. Quality by Design based development of non-destructive analytical techniques
13. Design space considerations for flexibility in analytical method development
Les mer
Provides insights into the QbD paradigms, specifically in the analytical field, which can increase successful implementation in routine work flow
Concise language for easy understanding of the novel and holistic concept
Covers key aspects of analytical development and validation
Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance
Les mer
Produktdetaljer
ISBN
9780128203323
Publisert
2021-01-15
Utgiver
Elsevier Science Publishing Co Inc; Academic Press Inc
Vekt
390 gr
Høyde
229 mm
Bredde
152 mm
Aldersnivå
P, 06
Språk
Product language
Engelsk
Format
Product format
Heftet
Antall sider
222