Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

Satinder Ahuja and Karen Mills Alsante (Eds.)012044982X, 9780120449828, 9780080507767

The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized.Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It’s objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.- Provides valuable information on isolation and characterization of impurities.- Gives a regulatory perspective on the subject.- Describes various considerations involved in meeting regulatory requirements.- Discusses various sources of impurities and degredation products.

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Table of contents :
Content:
Preface
Pages xi-xiii
Satinder Ahuja

Contributors
Pages xv-xvi

Overview: Isolation and characterization of impurities Original Research Article
Pages 1-25
Satinder Ahuja

Review of regulatory guidance on impurities Original Research Article
Pages 27-37
Radhika rajagopalan

Polymorphic and solvatomorphic impurities Original Research Article
Pages 39-73
Harry G. Brittain, Ales Medek

Impurities in drug products Original Research Article
Pages 75-88
Kenneth C. Waterman, Roger C. Adami, Jin Yang Hong

Strategies for investigation and control of process- and degradation-related impurities Original Research Article
Pages 89-117
Bernard A. Olsen, Steven W. Baertschi

Reference standards Original Research Article
Pages 119-143
Paul A. Culbert, Bruce D. Johnson

Sample selection for analytical method development Original Research Article
Pages 145-164
Hugh J. Clarke, Kenneth J. Norris

Sample preparation methods for the analysis of pharmaceutical materials Original Research Article
Pages 165-201
David T. Rossi, Kenneth G. Miller

Isolation methods I: Thin-layer chromatography Original Research Article
Pages 203-230
Pamela M. Gorman, Hong Jiang

Isolation methods II: Column chromatography Original Research Article
Pages 231-248
Mark Guinn, Ronald Bates, Benjamin Hritzko, Teri Shanklin, Glenn Wilcox, Sam Guhan

Mass spectral characterization Original Research Article
Pages 249-299
David J. Burinsky, Feng Wang

NMR characterization of impurities Original Research Article
Pages 301-339
Linda L. Lohr, Andrew J. Jensen, Thomas R. Sharp

Hyphenated characterization techniques Original Research Article
Pages 341-359
Thomas N. Feinberg

Solving impurity/degradation problems: Case studies Original Research Article
Pages 361-400
Karen M. Alsante, Todd D. Hatajik, Linda L. Lohr, Dinos Santafianos, Thomas R. Sharp

Index
Pages 401-414