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:
- The complete guide to measuring elemental impurities in pharmaceutical and nutraceutical materials.
- Covers heavy metals testing in the pharmaceutical industry from an historical perspective.
- Gives an overview of current USP Chapters <232> <233> and <2232> and ICH Q3D Step 4 Guidelines.
- Explains the purpose of validation protocols used in Chapter <233>, including how J-values are calculated
- Describes fundamental principles and practical capabilities of ICP-MS and ICP-OES.
- Offers guidelines about the optimum strategy for risk assessment
- Provides tips 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
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
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