Characterization Of Impurities And Degradants Using Mass Spectrometry

Author : Guodong Chen
Publisher : John Wiley & Sons
ISBN 13 : 0470922974
Total Pages : 402 pages
Book Rating : 4.72/5 ( download)

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Download or read book Characterization of Impurities and Degradants Using Mass Spectrometry written by Guodong Chen and published by John Wiley & Sons. This book was released on 2011-04-27 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.

Author : Osamah M. Albassam
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.71/5 ( download)

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Download or read book Using High Resolution Mass Spectrometry to Profile Impurities in Drugs from Different Sources written by Osamah M. Albassam and published by . This book was released on 2017 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Impurities in active pharmaceutical ingredients (APIs) include volatile and involatile organic compounds and inorganic anions and cations. The impurities in an API are acquired during the manufacturing process and may arise from impurities in reagents, side reactions and may, as in the case of ionic impurities associate with the molecule during purification processes. Impurity levels have to be controlled to conform to pharmacopoeial requirements; although this is less apparent in the case of organic and inorganic counterions. In the work reported in this thesis four applications of impurity profiling in APIs and API intermediates were investigated. In chapter 3 the removal of impurities in lipoic acid prior to crystallisation was investigated using high resolution mass spectrometry in combination with chemometric modelling of the data. Several impurities of lipoic acid were characterised by using MSn and the success of the purification process in removing impurities was verified. In chapter 4 the organic impurities in chlorpheniramine maleate were investigated using high resolution mass spectrometry in combination with chemometric modelling of the data. Several new impurities of chlorpheniramine maleate were characterised by using MSn and it was demonstrated that it was possible to distinguish between different manufacturers' batches of chlorpheniramine maleate according to their impurity profiles by using high resolution mass spectrometry data in combination with chemometric modelling. In chapter 5 the anionic impurities in different pharmaceutical bases were investigated by using capillary ion chromatography. The different pharmaceutical bases contained a wide range of trace ions as well as the main counter-anion. Aside from the anions being present as impurities they might have an impact of processing procedures such as crystallisation. In chapter 6 a range of techniques including nuclear magnetic resonance spectroscopy, high resolution LC-MSn, headspace gas chromatography mass spectrometry, anion and cation chromatography were applied to the analysis of 6-aminopenicillanic acid (6-APA) samples, provided by GSK, which had of low to high clarity values. It was not possible to find any direct association between clarity readings and the various impurity profiles although a number of new impurities in 6-APA were characterised.

Author : Satinder Ahuja
Publisher : Elsevier
ISBN 13 : 008050776X
Total Pages : 432 pages
Book Rating : 4.67/5 ( download)

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Download or read book Handbook of Isolation and Characterization of Impurities in Pharmaceuticals written by Satinder Ahuja and published by Elsevier. This book was released on 2003-06-26 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.

Author : Guodong Chen
Publisher : Springer Science & Business Media
ISBN 13 : 1441978623
Total Pages : 408 pages
Book Rating : 4.22/5 ( download)

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Download or read book Characterization of Protein Therapeutics using Mass Spectrometry written by Guodong Chen and published by Springer Science & Business Media. This book was released on 2014-07-08 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development.

Author : Mike S. Lee
Publisher : John Wiley & Sons
ISBN 13 : 0471721026
Total Pages : 576 pages
Book Rating : 4.24/5 ( download)

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Download or read book Integrated Strategies for Drug Discovery Using Mass Spectrometry written by Mike S. Lee and published by John Wiley & Sons. This book was released on 2005-09-02 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: New strategies and techniques for today's fast-paced discoveryprocess Today, the pressure is on for high-throughput approaches toaccelerate the generation, identification, and optimization ofmolecules with desirable drug properties. As traditional methods ofanalysis become antiquated, new analytical strategies andtechniques are necessary to meet sample throughput requirements andmanpower constraints. Among them, mass spectrometry has grown to bea front-line tool throughout drug discovery. Integrated Strategies for Drug Discovery Using Mass Spectrometryprovides a thorough review of current analytical approaches,industry practices, and strategies in drug discovery. The topicsrepresent current industry benchmarks in specific drug discoveryactivities that deal with proteomics, biomarker discovery,metabonomic approaches for toxicity screening, lead identification,compound libraries, quantitative bioanalytical support,biotransformation, reactive metabolite characterization, leadoptimization, pharmaceutical property profiling, sample preparationstrategies, and automation. THIS BOOK: * Clearly explains how drug discovery and mass spectrometry areinterconnected * Discusses the uses and limitations of various types of massspectrometry in various aspects of drug discovery * Prominently features analytical applications that requiretrace-mixture analysis * Provides industry applications and real-world examples * Shares historical background information on various techniques toaid in the understanding of how and why new methods are now beingemployed to analyze samples

Author : Roberto G. Wilson
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.51/5 ( download)

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Download or read book Secondary Ion Mass Spectrometry written by Roberto G. Wilson and published by . This book was released on 1988 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Author : Mike S. Lee
Publisher : John Wiley & Sons
ISBN 13 : 1118180720
Total Pages : 1362 pages
Book Rating : 4.23/5 ( download)

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Download or read book Mass Spectrometry Handbook written by Mike S. Lee and published by John Wiley & Sons. This book was released on 2012-04-16 with total page 1362 pages. Available in PDF, EPUB and Kindle. Book excerpt: Due to its enormous sensitivity and ease of use, mass spectrometry has grown into the analytical tool of choice in most industries and areas of research. This unique reference provides an extensive library of methods used in mass spectrometry, covering applications of mass spectrometry in fields as diverse as drug discovery, environmental science, forensic science, clinical analysis, polymers, oil composition, doping, cellular research, semiconductor, ceramics, metals and alloys, and homeland security. The book provides the reader with a protocol for the technique described (including sampling methods) and explains why to use a particular method and not others. Essential for MS specialists working in industrial, environmental, and clinical fields.

Author : Mike S. Lee
Publisher : John Wiley & Sons
ISBN 13 : 1118605195
Total Pages : 290 pages
Book Rating : 4.96/5 ( download)

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Download or read book Protein Analysis using Mass Spectrometry written by Mike S. Lee and published by John Wiley & Sons. This book was released on 2017-06-19 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Presents Practical Applications of Mass Spectrometry for Protein Analysis and Covers Their Impact on Accelerating Drug Discovery and Development Covers both qualitative and quantitative aspects of Mass Spectrometry protein analysis in drug discovery Principles, Instrumentation, Technologies topics include MS of peptides, proteins, and ADCs , instrumentation in protein analysis, nanospray technology in MS protein analysis, and automation in MS protein analysis Details emerging areas from drug monitoring to patient care such as Identification and validation of biomarkers for cancer, targeted MS approaches for biomarker validation, biomarker discovery, and regulatory perspectives Brings together the most current advances in the mass spectrometry technology and related method in protein analysis

Author : Satinder Ahuja
Publisher : Academic Press
ISBN 13 : 9780120449828
Total Pages : 444 pages
Book Rating : 4.2X/5 ( download)

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Download or read book Handbook of Isolation and Characterization of Impurities in Pharmaceuticals written by Satinder Ahuja and published by Academic Press. This book was released on 2003-07-18 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product. This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements. It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization. - Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.

Author : Stacie Liane Eldridge
Publisher :
ISBN 13 :
Total Pages : 271 pages
Book Rating : 4.67/5 ( download)

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Download or read book Development of Analytical Methods for Trace Impurity Analysis and Structure Determination of Heparin/heparan Sulfate-derived Oligosaccharides written by Stacie Liane Eldridge and published by . This book was released on 2009 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of this dissertation is to develop improved analytical methods and approaches that address the difficulties in separating and detecting pharmaceutical impurities and heparin oligosaccharides. The specific methods used were capillary electrophoresis with ultraviolet detection (CE-UV), liquid chromatography-mass spectrometry (LC-MS), with special emphasis given to capillary isotachophoresis-nuclear magnetic resonance (cITP-NMR). The FDA requires structural identification of all pharmaceutical impurities and degradants present at levels 0.1% of the parent compound. This poses a significant analytical challenge since these impurities are typically present in trace amounts along with high levels of the parent drug and matrix components. Greater complications arise in the analysis of heparin and heparan sulfate (HS). These highly sulfated linear polysaccharides display a wide range of biological activities through interaction with proteins. The enzymatic modifications that occur during biosynthesis for the purposes of cell adaptation and regulation, contribute to the heterogeneity of heparin and HS, making them a challenge to characterize.