Measuring elemental impurities in pharmaceuticals : a practical guide

Authors : Thomas, Robert
Edition : 1
Year : 2018
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 , , and , 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 , 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. 

• 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 InformationIndexã

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