دانلود کتاب اندازه گیری عناصر افزودنی در داروسازی
Measuring Elemental Impurities in Pharmaceuticals, 1ed
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.
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
۱. Testing for Heavy Metals. An ACS Perspective
۲. Elemental Impurities in Pharmaceuticals. An Overview
۳. An Overview of ICP. Mass Spectrometry
۴. Principles of Ion Formation
۵. Sample Introduction
۶. Plasma Source
۷. Interface Region
۸. Ion-Focusing System
۹. Mass Analyzers. Quadrupole Technology
۱۰. Mass Analyzers. Double-Focusing Magnetic Sector Technology
۱۱. Mass Analyzers. Time-of-Flight Technology
۱۲. Mass Analyzers. Collision/Reaction Cell and Interface Technology
۱۳. Ion Detectors
۱۴. Peak Measurement Protocol
۱۵. Methods of Quantitation
۱۶. Review of ICP-MS Interferences
۱۷. Routine Maintenance
۱۸. Collecting and Preparing the Sample for Analysis
۱۹. Sample Digestion Techniques for Pharmaceutical Samples
۲۰. Performance and Productivity Enhancement Techniques
۲۱. Coupling ICP-MS with Chromatographic Separation Techniques for Speciation Studies
۲۲. Fundamental Principles,. Method Development and Operational Requirements of ICP-OES
۲۳. What Atomic Spectroscopic Technique is Right for Your Lab?
۲۴. Do You Know What It Costs to Run Your Atomic Spectroscopy Instrumentation?
۲۵. The Risk Assessment Approach
۲۶. Regulatory Inspection Readiness
۲۷. How to Select an ICP Mass Spectrometer The Most Important Analytical Considerations
۲۸. Plasma Spectrochemistry Glossary of Terms
۲۹. Useful Contact Information
لینک کوتاه : https://bookbaz.ir/?p=86872
نویسنده : Robert Thomas
ناشر : CRC Press; 1 edition
سال انتشار : 2018
زبان کتاب : انگلیسی
نوع فایل : PDF
تعداد صفحات : 502
(ISBN) شابک : 1138197963
قیمت کتاب درآمازون : $95.75
حجم فایل : 28 MB