Handbook of Isolation and Characterization of Impurities in Pharmaceuticals
eBook - PDF

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

  1. 430 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals

About this book

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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Yes, you can access Handbook of Isolation and Characterization of Impurities in Pharmaceuticals by Satinder Ahuja,Karen Mills Alsante in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
Academic Press
Year
2003
Print ISBN
9780120449828
eBook ISBN
9780080507767
Topic
Medicine
Subtopic
Pharmacology

Table of contents

  1. Cover
  2. Title Page
  3. Copyright Page
  4. CONTENTS
  5. PREFACE
  6. Contributors
  7. Chapter 1. Overview: Isolation and Characterization of Impurities
  8. Chapter 2. Review of Regulatory Guidance on Impurities
  9. Chapter 3. Polymorphic and Solvatomorphic Impurities
  10. Chapter 4. Impurities in Drug Products
  11. Chapter 5. Strategies for Investigation and Control of Process- and Degradation-Related Impurities
  12. Chapter 6. Reference Standards
  13. Chapter 7. Sample Selection for Analytical Method Development
  14. Chapter 8. Sample Preparation Methods for the Analysis of Pharmaceutical Materials
  15. Chapter 9. Isolation Methods I: Thin-Layer Chromatography
  16. Chapter 10. Isolation Methods II: Column Chromatography
  17. Chapter 11. Mass Spectral Characterization
  18. Chapter 12. NMR Characterization of Impurities
  19. Chapter 13. Hyphenated Characterization Techniques
  20. Chapter 14. Solving Impurity/Degradation Problems: Case Studies
  21. Index