Measuring Elemental Impurities in Pharmaceuticals: A Practical Guide (Hardback) book cover

Measuring Elemental Impurities in Pharmaceuticals

A Practical Guide

By Robert Thomas

CRC Press

474 pages

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Hardback: 9781138197961
pub: 2018-02-02
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pub: 2018-01-29
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Description

Recent regulations on heavy metal testing have required the pharmaceutical industry to monitor a suite of elemental impurities in pharmaceutical raw materials, drug products and dietary supplements. These new directives s are described in the new United States Pharmacopeia (USP) Chapters <232>, <233>, and <2232>, together with Q3D, Step 4 guidelines for elemental impurities, drafted by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), a consortium of global pharmaceutical associations, including the European Pharmacopeia (Ph.Eur.), the Japanese Pharmacopeia (JP) and the USP. This book provides a complete guide to the analytical methodology, instrumental techniques and sample preparation procedures used for measuring elemental impurities in pharmaceutical and nutraceutical materials.

It offers readers the tools to better understand plasma spectrochemistry to optimize detection capability for the full suite of elemental PDE (Permitted Daily Exposure) levels in the various drug delivery categories. Other relevant information covered in the book includes:

  • Coverage of heavy metals testing in the pharmaceutical industry from a historical perspective.
  • Overview of current status of USP Chapters <232> <233>, <2232> and ICH Q3D Step 4 guidelines.
  • An explanation of the strict validation protocols required to meet data quality objectives, including how real-world J-values are calculated.
  • Guidelines on the optimum strategy for risk assessment.
  • Insight on how best to prepare and present your data for regulatory inspection.

An indispensable resource, the fundamental principles and practical benefits of ICP-OES and ICP-MS are covered in a reader-friendly format that a novice, who is carrying out elemental impurities testing in the pharmaceutical and nutraceutical communities, will find easy to understand.

Table of Contents

Table of Contents

Foreword:

Preface:

Acknowledgements:

Author Bio:

Chapter 1: Testing for Heavy Metals: An ACS Perspective

Chapter 2: Elemental impurities in Pharmaceuticals: An Overview

Chapter 3: An Overview of ICP Mass Spectrometry

Chapter 4: Principles of Ion formation

Chapter 5: Sample Introduction

Chapter 6: Plasma Source

Chapter 7: Interface Region

Chapter 8: Ion-Focusing System

Chapter 9: Mass Analyzers: Quadrupole Technology

Chapter 10: Mass Analyzers: Double-Focusing Magnetic Sector Technology

Chapter 11: Mass Analyzers: Time-Of-Flight Technology

Chapter 12: Mass Analyzers: Collision/Reaction Cell and Interface Technology

Chapter 13: Ion Detectors

Chapter 14: Peak Measurement Protocol

Chapter 15: Methods of Quantitation

Chapter 16: Review of ICP-MS Interferences

Chapter 17: Routine Maintenance

Chapter 18: Collecting and Preparing the Sample for Analysis

Chapter 19: Sample Digestion Techniques for Pharmaceutical Samples

Chapter 20: Performance and Productivity Enhancement Techniques

Chapter 21: Coupling ICP-MS with Chromatographic Separation Techniques for Speciation Studies

Chapter 22: Fundamental Principles, Method Development and Operational Requirements of ICP-OES

Chapter 23: What Atomic Spectro-scopic Technique is Right for Your Lab?

Chapter 24: Do You Know What it Costs to Run your Atomic Spectroscopy Instrumentation?

Chapter 25: The Risk Assessment Approach

Chapter 26: Regulatory Inspection Readiness

Chapter 27: How to Select an ICP Mass Spectrometer: Some Important Analytical Considerations

Chapter 28: Plasma Spectrochemistry Glossary of Terms

Chapter 29: Useful Contact Information

Index

 

About the Author

Robert J. Thomas has worked in the field of trace element analysis for over 40 years, including 24 years for an ICP-MS manufacturer and 15 years as a principal of his own consulting company. He has served on the ACS (American Chemical Society) Reagent Chemical Committee for the past 17 years as leader of the elemental impurities task force where he has worked closely with the USP to align heavy metal testing procedures in analytical reagents with those of pharmaceutical materials. He has authored almost 100 publications on trace element analysis and written three textbooks on ICP-MS and related topics, including this new book, which focuses on the new global directives on elemental impurities in pharmaceutical materials and dietary supplements. He is currently editor and frequent contributor to the Atomic Perspectives Column in Spectroscopy Magazine. He has a graduate degree in Analytical Chemistry from the University of Wales in the UK and is a Fellow of the Royal Society of Chemistry (FRSC, and a Chartered Chemist (CChem

About the Series

Practical Spectroscopy

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Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013010
SCIENCE / Chemistry / Analytic
TEC012000
TECHNOLOGY & ENGINEERING / Food Science