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Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design

Authors
Publisher Elsevier Science Publishing Co Inc
Year 15/01/2021
Pages 222
Version paperback
Readership level Professional and scholarly
ISBN 9780128203323
Categories Production & quality control management, Pharmacology, Pharmacy / dispensing, Analytical chemistry, Biotechnology
$160.97 (with VAT)
712.00 PLN / €153.35 / £129.94
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Book description

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.

Handbook of Analytical Quality by Design

Table of contents

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

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