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Specification of Drug Substances and Products - 1st Edition - ISBN: 9780080983509, 9780080983431

Specification of Drug Substances and Products

1st Edition

Development and Validation of Analytical Methods

Hardcover ISBN: 9780080983509
eBook ISBN: 9780080983431
Imprint: Elsevier
Published Date: 17th September 2013
Page Count: 390
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Specification of Drug Substances and Products: Development and Validation of Analytical Methods is a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development and validation of analytical methods. This book is intended as more than a review of new regional guidelines, existing regulatory guidance, and industry practices. It provides a hands-on guide to understanding and applying these in practice. The authors discuss critical issues, novel approaches, and future directions while also providing insight into how International Guidelines were developed and the rationale behind them.

Key Features

  • Guide to industry best practices of analytical methodologies used in the specification of new drug substances and products (e.g. DOE, QbD)
  • Critical assessment of the application of ICH guidelines on method validation and specification setting, written by experts involved in the development and application of the guidelines to aid understanding of requirements and what is expected by regulatory authorities
  • Direct applicability to the day-to-day activities in drug development and the potential to increase productivity


For undergraduate pharmacy students and chemistry students; postgraduate students and faculty in analytical chemistry, pharmaceutical chemistry, pharmaceutical analysis, pharmaceutics and medicinal chemistry; analytical scientists in government, pharmaceutical industry and biotechnology industry and regulatory agencies.

Table of Contents

Part One: Basic Concepts and Definitions
1. Introduction
2. General Principles and Regulatory Considerations: Specifications
3. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods
4. General Principles and Regulatory Considerations: Method Validation

Part Two: Universal Tests
5. Description and Identification
6. Assay, and Impurities
7. Residual Solvents
8. Inorganic Impurities (Heavy Metals)

Part Three: Specific Tests: Drug Substances
9. Solid-State Characterization
10. Chiral Methods
11. Water Determination

Part Four: Specific Tests: Drug Products
12. Dissolution and Disintegration
13. Extractables and Leachables
14. Potency Assays for Biomolecules
15. Host Cell Protein Assays

Part Five: Pharmacopeial Methods
16. Pharmacopeial Methods and Tests

Part Six: Microbial Methods
17. Sterile and Non-Sterile Products

Part Seven: Biological Fluids
18. Biological Fluids


No. of pages:
© Elsevier 2013
17th September 2013
Hardcover ISBN:
eBook ISBN:


"...a valuable addition to a pharmaceutical scientists’ library….relevant and of interest to various “stake-holders” in the drug development arena, including chemists, analysts, and programme managers. I can recommend it."--Organic Process Research & Development Journal, Sep-14

"Its main role is to explain how to meet the most recent International Conference on Harmonization guidelines for drug development. The book is organized to offer a critical and comprehensive account of the approaches used to identify the key determinants of quality production that affect the safety, effectiveness, and marketability of a drug.", April 2014

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