About the book

The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products.  Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.

Contents

PART I: METHODOLOGY

CHAPTER 1

Introduction to Mass Spectrometry (Pages: 1-57)

CHAPTER 2

LC Method Development and Strategies (Pages: 59-79)

CHAPTER 3

Rapid Analysis of Drug-Related Substances Using Desorption Electrospray Ionization and Direct Analysis in Real Time Ionization Mass Spectrometry (Pages: 81-108)

CHAPTER 4

Orbitrap High-Resolution Applications (Pages: 109-134)

CHAPTER 5

Structural Characterization of Impurities and Degradation Products in Pharmaceuticals Using High-Resolution LC-MS and Online Hydrogen/Deuterium Exchange Mass Spectrometry (Pages: 135-181)

CHAPTER 6

Isotope Patten Recognition on Molecular Formula Determination for Structural Identification of Impurities (Pages: 183-211)

PART II: APPLICATION

CHAPTER 7

Practical Application of Very High-Pressure Liquid Chromatography across the Pharmaceutical Development–Manufacturing Continuum (Pages: 213-229)

CHAPTER 8

Impurity Identification for Drug Substances (Pages: 231-250)

CHAPTER 9

Impurity Identification in Process Chemistry by Mass Spectrometry (Pages: 251-277)

CHAPTER 10

Structure Elucidation of Pharmaceutical Impurities and Degradants in Drug Formulation Development (Pages: 279-335)

CHAPTER 11

Investigation of Degradation Products and Extractables in Developing Topical OTC (Over the Counter) and NCE (New Chemical Entity) Consumer Healthcare Medication Products (Pages: 337-390)

CHAPTER 12

Characterization of Impurities and Degradants in Protein Therapeutics by Mass Spectrometry (Pages: 391-426)

CHAPTER 13

Identification and Quantification of Degradants and Impurities in Antibodies (Pages: 427-459)