Specification of Drug Substances and Products

Specification of Drug Substances and Products

Development and Validation of Analytical Methods

2nd Edition - July 23, 2020

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  • Editors: Christopher M. Riley, Thomas W. Rosanske, George Reid
  • Paperback ISBN: 9780081028247
  • eBook ISBN: 9780081028254

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Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis of the requirements and approaches to setting specifications for new pharmaceutical products, with an emphasis on phase-appropriate development, validation of analytical methods, and their application in practice. This thoroughly revised second edition covers topics not covered or not substantially covered in the first edition, including method development and validation in the clinical phase, method transfer, process analytical technology, analytical life cycle management, special challenges with generic drugs, genotoxic impurities, topical products, nasal sprays and inhalation products, and biotechnology products. The book's authors have been carefully selected as former members of the ICH Expert Working Groups charged with developing the ICH guidelines, and/or subject-matter experts in the industry, academia and in government laboratories.

Key Features

  • Presents a critical assessment of the application of ICH guidelines on method validation and specification setting
  • Written by subject-matter experts involved in the development and application of the guidelines
  • Provides a comprehensive treatment of the analytical methodologies used in the analysis, control and specification of new drug substances and products
  • Covers the latest statistical approaches (including analytical quality by design) in the development of specifications, method validation and shelf-life prediction


Scientists, managers, educators and consultants involved in the development and regulation of pharmaceutical products, especially those concerned with the Chemistry, Manufacturing and Controls (CMC) aspects of drug development. Includes analytical chemists, pre-formulation scientists, formulation scientists, process chemists, process engineers, and pharmaceutical microbiologists as well as those involved in regulatory affairs, quality control and quality assurance. Academic researchers involved in drug research and development, particularly those who collaborate with industry or serve as consultants; faculty and students pursuing post-graduate degrees in Pharmaceutical Analysis, Pharmaceutics or Pharmaceutical Chemistry and certificates in Regulatory Affairs or Quality Assurance

Table of Contents

    1. Introduction
    C. Riley, T. Rosanske and G. Reid
    2. General Principles and Regulatory Considerations: Specifications and Shelf Life Setting
    C. Riley and H. Yang
    3. General Principles and Regulatory Considerations: Method Development and Validation
    T. Rosanske
    4. Application of Quality by Design (QbD) to the Development and Validation of Analytical Methods
    D. Lloyd, J. Bergum and Q. Wang
    5. Analytical Methods in the Clinical Phase of Development
    J. Orr and G. Reid
    6. Method Transfer
    G. Reid
    7. Process Analytical Technology
    I. Clegg

    8. Description and Identification
    E. Parente
    9. Assay and Impurities: Specifications
    E. Kikovska-Stojanovska, C. Riley, A. Clarke, and R. Phelps 
    10. Assay and Impurities: Method Development and Life-Cycle Management
    A. Clarke, C. Riley,and E. Kikovska-Stojanovska 
    11. Assay and Impurities: Method Validation
    C. Riley, A. Clarke, E. Kikovska-Stojanovska
    12. Mutagenic Impurities
    S. Baerschi and B. Olsen   
    13. Residual Solvents
    G. Reid
    14. Inorganic Impurities (Elemental Impurities)
    E. Parente

    15. Solid State Characterization
    P. Tishmack, P. Smith, and P. Chen
    16. Chiral Methods
    B. He and D. Lloyd 
    17. Water Determination
    D. Armstrong and M. Talebi

    18. Drug Release: Oral Products
    V. Gray and T. Rosanske 
    19. Topical Products
    K. Thakker and R. Klein
    20. Extractables and Leachables
    K. Moyer and J. Scull

    21..Regulatory Requirements for Setting Drug Substance and Drug Product Specifications 
    K. Amsberry and Y.H. Lai
    22. Validation of Analytical Methods for Biotechnology Products
    J. Dally and M, Monck

    23. Pharmacopeial Methods and Test (Updated)
    E. Sheinin

    24. Biological Fluids
    L. Yuan, L. Wang, L. Pan, Q. Ji

Product details

  • No. of pages: 694
  • Language: English
  • Copyright: © Elsevier 2020
  • Published: July 23, 2020
  • Imprint: Elsevier
  • Paperback ISBN: 9780081028247
  • eBook ISBN: 9780081028254

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

George Reid

Affiliations and Expertise

Principal Consultant, Cardinal Health, Kansas City, MO, USA

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