Specification of Drug Substances and Products book cover

Specification of Drug Substances and Products

Development and Validation of Analytical Methods

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.

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.

Hardbound, 390 Pages

Published: September 2013

Imprint: Elsevier

ISBN: 978-0-08-098350-9


  • "...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."--ProtoView.com, April 2014


  • 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
    5. Part Two: Universal Tests

    6. Description and Identification
    7. Assay, and Impurities
    8. Residual Solvents
    9. Inorganic Impurities (Heavy Metals)
    10. Part Three: Specific Tests: Drug Substances

    11. Solid-State Characterization
    12. Chiral Methods
    13. Water Determination
    14. Part Four: Specific Tests: Drug Products

    15. Dissolution and Disintegration
    16. Extractables and Leachables
    17. Potency Assays for Biomolecules
    18. Host Cell Protein Assays
    19. Part Five: Pharmacopeial Methods

    20. Pharmacopeial Methods and Tests
    21. Part Six: Microbial Methods

    22. Sterile and Non-Sterile Products
    23. Part Seven: Biological Fluids

    24. Biological Fluids


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