Specification of Drug Substances and Products

Specification of Drug Substances and Products

Development and Validation of Analytical Methods

1st Edition - August 21, 2013

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  • Editors: Christopher M. Riley, Thomas W. Rosanske
  • eBook ISBN: 9780080983431
  • Hardcover ISBN: 9780080983509

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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

Product details

  • No. of pages: 390
  • Language: English
  • Copyright: © Elsevier 2013
  • Published: August 21, 2013
  • Imprint: Elsevier
  • eBook ISBN: 9780080983431
  • Hardcover ISBN: 9780080983509

About the Editors

Christopher M. Riley

Dr Riley is President, Riley and Rabel Consulting Services, Inc. He received a bachelor’s degree in pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, England. He was a post-doctoral fellow at the University of Kansas in the Department of Pharmaceutical Chemistry (1981-1982) before joining the faculty of the Department of Pharmaceutics at the University of Florida. He returned to the University of Kansas as faculty member in 1986 where he remained until 1994. He was Vice President and Head of Analytical R&D at Dupont Pharmaceuticals (previously Dupont Merck) from 1994 to 2001. He joined ALZA 2001, a subsidiary of Johnson & Johnson, where he had positions of increasing responsibility up to Vice President and West Coast Site Head ChemPharm Development. He left ALZA in May 2007 to form Riley and Rabel Consulting Services, Inc., which provides consulting services to the Pharmaceutical and Biotechnology Industries, specializing in Analytical and Pharmaceutical Development, CMC Strategy, Organizational and Managerial Effectiveness and Patent Litigation. He has co-authored more than 140 book chapters and papers in peer-reviewed journals, as well as five books. He was awarded the Conference Science Award of the Royal Pharmaceutical Society of Great Britain and the Jubilee Medal of the Chromatographic Society. He was elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and served as the chair of the Analysis and Pharmaceutical Quality Section of AAPS and a Member of the AAPS Executive Committee. Dr. Riley has served as member and chair of the PhRMA Analytical Technical Committee (ATC), as well as a member and chair of the PhRMA Technical Leadership Committee (TLC). Dr. Riley represented PhRMA on the ICH Expert Working Group on Impurities in Drug Substances (Q3A) and Drug Products (Q3B) and was Chair of the PhRMA Working Group on Genotoxic Impurities.

Affiliations and Expertise

President of Riley and Rabel Consulting Services, Maryville,MO,USA.

Thomas W. Rosanske

Former Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee.

Affiliations and Expertise

Consultatnt, Lee's Summit, MO, USA

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  • yushi w. Thu Jul 04 2019

    Specification of Drug Substances and Products Development and Validation of Analytical Methods

    A good practise for setting specification for API and product