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Practical Spectroscopy

Thomas R: Measuring Elemental Impurities
in Pharmaceuticals

Measuring Elemental Impurities in Pharmaceuticals

A Practical Guide

Overview of the USP Mission. Traditional Heavy Metals Testing Under Chapter 231. The Process for Change? Proposed New Chatpers &lt;232&gt; &lt;233&gt; and &lt;2232&gt;. The Role/Mission of th eICH and EMA in Setting Global Standards for Elemental Impurities in Drug Products. The ICH/USP Alignment Process. Understanding PDE Limits Defined in Chapter &lt;232&gt; and &lt;2232&gt;. Speciated Form: When is it Required. Options for Compliance. Testing-based, Risk-based Approach. Anaylytical Procedures and Validation Protocols Described in Chapter &lt;233&gt;. Sample Preparation Procedures. Which Techniques are Suggested. Validation Protocols. J Values. Calibration. Drift. Detectability. Precision. Specificity. Accuracy. Ruggedness. Limit of Quantification. Linear Range. Comparison of Plasma Spectrochemical Techniques Defined in Chapter &lt;233&gt;. Guidance on what is the Most Appropriate Technique to use. Productivity Enhancement Tools. Regulatory Compliance. Is Your Laboratory Ready for the FDA?. 21CFR Prat 11 Qualification. Computer Systems Validation/Electronic Records. Fundamentals Principles of ICP-OES. Principles of Atomic Excitation/Emission. Sample Introduction. Plasma Source. Opticial Configurations. Solid State Detector Technology. Understanding Interferences. Fundamental Principles of ICP-MS. Principles of Ion Formation. Sample Introduction. Plasma Source. Interface Region. Ion Focusing System. Mass Analyzers. Ion Detection. Peak Measurement Protocol. Methods of Quantitation. Review of Interferences. Contamination Issues. Routine Maintenance. Alternative Sample Introduction Techniques. Trace Element Speciation. Glossary of Terms Used in ICP-MS. References. Final Thoughts, Useful Contact Information. Index.

This newly revised edition incorporates the latest advances in instrumentation, computerization, calibration, and method development in NIR spectroscopy and underscores current trends in sample preparation, calibration transfer, process control, data analysis, and commercial NIR instrumentation.

Handbook of Near-Infrared Analysis

Written by one of the very first practitioners of ICP-MS, a Practical Guide to ICP-MS and Other AS Techniques: A Tutorial for Beginners presents ICP-MS in a completely novel and refreshing way

A Tutorial for Beginners

Practical Guide to ICP-MS and other Atomic Spectroscopy Techniques

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 &lt;232&gt;, &lt;233&gt;, and &lt;2232&gt;, 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 &lt;232&gt; &lt;233&gt; and &lt;2232&gt; and ICH Q3D Step 4 Guidelines.
Explains the purpose of validation protocols used in Chapter &lt;233&gt;, 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.

Presenting an in-depth discussion of the fundamental principles, analytical advantages, and practical capabilities of ICP-MS, this volume offers key concepts in a reader-friendly format suitable for novices. Written by an insider with more than 25 years experience in product development, customer support, and technical marketing for an ICP-MS instrument vendor, the book highlights this powerful ultra trace-element technique as a practical solution to real-world problems. The new edition covers new technologies and applications, and discusses nonstandard sampling accessories and much more.

A Tutorial for Beginners, Third Edition

Practical Guide to ICP-MS

Helps to improve fundamentals and applications of various modes of x-ray spectrometry, including total reflection and polarized beam x-ray fluorescence analysis, and synchrotron radiation induced x-ray emission. This title intends to promote the measurement of samples while reducing the scattered background in the x-ray spectrum.

Handbook of X-Ray Spectrometry

Covers principles of Raman theory, analysis, instrumentation, and measurement, specifying benefits of Raman spectroscopy in a variety of industrial and academic fields, and how to cultivate growth in various disciplines. This book also contains case studies that illustrate techniques in data extraction and analysis.

From the Research Laboratory to the Process Line

Handbook of Raman Spectroscopy

Presenting a novel view of spectrophotomagnetic analysis, this book provides a detailed classification of reactions used for the spectrophotometric determination of both inorganic and organic compounds based on the chemical properties of analytes, reagents, and reaction products. It considers the practical use of spectrophotomagnetic analysis in various disciplines such as pharmacology and environmental science, and suggests specific approaches for the spectrophotomagnetic determination of particular analytes.

Spectrophotometric Reactions

Presents an introduction to the fundamental principles of infrared microspectroscopy (IMS). This book describes how IMS is used to solve specific microanalytical problems in a variety of disciplines, including forensic analysis, art conservation, and geological, pharmaceutical and electronics research.

Practical Guide to Infrared Microspectroscopy

Presents coverage of internal reflection spectroscopy (IRS) and its applications to polymer, semiconductor, biological, electrochemical and membrane research. It describes the theory and procedures and identifies the spectral regions, from materials characterization to process monitoring.

Theory and Applications

Internal Reflection Spectroscopy

Wiley Series in Corrosion

Corrosion of Nickel-Based Alloys

Cultured Meat: Producing Meat Without Animals

The Encyclopedia of Lipidomics will present a complete overview of the field from fundamentals to new discoveries and from concepts, theories and experimental techniques to clinical and industrial applications. The book will develop with the active involvement of a strong editorial board comprised of leaders from the field. The Encyclopedia of Lipidomics intends to be a comprehensive reference resource serving to bridge the gap between clinical and basic science investigators and provide authoritative and digested information to students, scientists as well as non specialists. The book will have an edge over protocol type of works and databases in terms of having wider coverage through rigorous essays on terms, concepts, experimental and analytical techniques, applications and new challenges. Since lipidomics has strong linkages with several of the other biomedical and life sciences disciplines, the proposed encyclopedia will have a wide audience including graduate students, researchers and different levels of scientists in biomedicine, cellular and molecular biology, bioengineering, physiological and biochemistry, and pharmacology across both academia and industry.

Encyclopedia of Lipidomics

How to Succeed as a Scientist Entrepreneur

LAUNCH

A follow-up to the experimental and instrumental aspects described in Basic Principles of Analytical Ultracentrifugation, the volume Sedimentation Velocity Analytical Ultracentrifugation: Discrete Species and Size-Distributions of Macromolecules and Particles describes the theory and practice of data analysis. Mathematical models for the sedimentation process and the evolution of detected signals are developed in a comprehensive framework, jointly with the description of current and historical strategies for how to extract from noisy experimental data the physical parameters of interest, such as size, mass, and shape, composition, and polydispersity of sedimenting particles. The methods are extensively illustrated, and supported with practical applications, as well as cross-references where to find the methods in the public domain software SEDFIT and SEDPHAT. The systems covered are discrete or polydisperse mixtures of sedimenting molecules or particles in dilute solution, such as proteins and other biomolecules and their stable complexes, man-made polymers, and nanoparticles, observed in different optical systems. These methods form the essential foundation for the analysis of dynamic interacting systems, which are covered in a separate volume.

Sedimentation Equilibrium Analytical Ultracentrifugation

The third edition of this book has seven new chapters. Six of these expand the coverage of polyphenolic compounds, both major and minor, with the seventh addressing the analysis of probiotics, the first book to do so. The book also includes specialty information such as the use of residues from vineyards and oil production for phenolic compounds. Thoroughly revised and expanded by leading scientists, the third edition of this highly successful book promises to be an invaluable source of information.

Methods of Analysis for Functional Foods and Nutraceuticals, Third Edition

Neurotoxicity is epidemic in modern society. While in recent years there has been an explosion of basic toxicological research concerning neurotoxicity, this information has not been translated for clinical practice. As a result, health professionals are in the dark as to the potential causes of neurotoxicity, the signs and symptoms, and the treatment. The Neurotoxicity Guidebook, 2nd Edition will provide an overview of the field of applied neurotoxicology, in-depth case reports showing a method for evaluating cases of neurotoxicity, in-depth coverage of some specific neurotoxic agents, and an introduction to treating neurotoxicity cases.

Neurotoxicity Guidebook, Second Edition

Glial Mechanisms in Sleep and Circadian Biology presents a comprehensive and up-to-date discussion of the role of glial cells in numerous, often unexpected, aspects of sleep. It seamlessly links glial cell activity to the multi-system processes that affect sleep. Experts in the field discuss how glial cells influence the sleep-wake cycle, the accumulation and discharge of sleep drive, the timing of sleep and wake across the 24-hour day, and how glial cells may govern important sleep functions (e.g., brain plasticity and metabolism). This is a book that could well change scientists’ and practitioners’ traditional beliefs about the factors underlying sleep. Users will find the book's content at the forefront of one of the hottest topics in basic sleep research. Over the last decade, scientists have made breakthrough discoveries revealing that sleep is not only a product of neurons, but of neuronal-glial interactions.

Glial Mechanisms in Sleep and Circadian Biology

Series in Materials Science and Engineering

This book provides an introduction to the geometrical and topological methods that have become essential tools for soft condensed matter physicists. The emphasis is on providing mathematical tools in clear but precise language, focusing on fundamental concepts using real examples to illustrate for readers in vivid, three-dimensional fashion. The motivation is clearly provided using problems from soft condensed matter, from the packing of colloids to liquid crystals and thermal fluctuations of lipid membranes.

Geometry and Topology of Soft Materials

This book will not only deal with the analysis of nutraceuticals, but will also focus on the extraction and purification of the analytes using newer tools/instruments. It will also help the analyst during the actual estimation of these compounds from different matrices.

Practical Guide to LC Analysis of Nutraceuticals

Clinical Pharmacy and Therapeutics

Measuring Elemental Impurities in Pharmaceuticals

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