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Handbook of isolation and characterization of impurities in pharmaceuticals

Author: Satinder Ahuja; Karen Mills Alsante
Publisher: Amsterdam ; Boston : Academic Press, 2003.
Series: Separation science and technology (San Diego, Calif.), v. 5.
Edition/Format:   Print book : English : 1st edView all editions and formats
Summary:
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  Read more...
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Genre/Form: Handbook
Laboratory Manual
Handbooks and manuals
Handbooks, manuals, etc
Guides, manuels, etc
Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Satinder Ahuja; Karen Mills Alsante
ISBN: 012044982X 9780120449828
OCLC Number: 51437837
Description: xvi, 414 pages : illustrations ; 27 cm
Contents: OVERVIEW: ISOLATION AND CHARACTERIZATION OF IMPURITIES; REVIEW OF REGULATORY GUIDANCE ON IMPURITIES; POLYMORPHIC & SOLVATOMORPHIC IMPURITIES; IMPURITIES IN DRUG PRODUCTS; STRATEGIES FOR INVESTIGATION AND CONTROL OF PROCESS AND DEGRADATION-RELATED IMPURITIES; REFERENCE STANDARDS; SAMPLE SELECTION FOR ANALYTICAL METHOD DEVELOPMENT; SAMPLE PREPARATION METHODS; ISOLATION METHODS I: THIN-LAYER CHROMATOGRAPHY; ISOLATION METHODS II: COLUMN CHROMATOGRAPHY; MASS SPECTRAL CHARACTERIZATION; NMR CHARACTERIZATION OF IMPURITES; HYPHENATED CHARACTERIZATION TECHNIQUES; SOLVING IMPURITY/DEGRADATION PROBLEMS: CASE STUDIES
Series Title: Separation science and technology (San Diego, Calif.), v. 5.
Responsibility: edited by Satinder Ahuja, Karen Mills Alsante.
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Abstract:

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.

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<http:\/\/www.worldcat.org\/oclc\/51437837<\/a>> # Handbook of isolation and characterization of impurities in pharmaceuticals<\/span>\n\u00A0\u00A0\u00A0\u00A0a \nschema:CreativeWork<\/a>, schema:Book<\/a> ;\u00A0\u00A0\u00A0\nlibrary:oclcnum<\/a> \"51437837<\/span>\" ;\u00A0\u00A0\u00A0\nlibrary:placeOfPublication<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/943559885#Place\/amsterdam<\/a>> ; # Amsterdam<\/span>\n\u00A0\u00A0\u00A0\nlibrary:placeOfPublication<\/a> <http:\/\/id.loc.gov\/vocabulary\/countries\/ne<\/a>> ;\u00A0\u00A0\u00A0\nlibrary:placeOfPublication<\/a> <http:\/\/dbpedia.org\/resource\/Boston<\/a>> ; # Boston<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/id.worldcat.org\/fast\/898890<\/a>> ; # Drugs--Purification<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/943559885#Topic\/medicaments_purification<\/a>> ; # M\u00E9dicaments--Purification<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/943559885#Topic\/drugs_purification<\/a>> ; # Drugs--Purification<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/943559885#Topic\/technology_pharmaceutical_methods<\/a>> ; # Technology, Pharmaceutical--methods<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/id.worldcat.org\/fast\/898911<\/a>> ; # Drugs--Separation<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/dewey.info\/class\/615.19\/e21\/<\/a>> ;\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/943559885#Topic\/medicaments_separation<\/a>> ; # M\u00E9dicaments--S\u00E9paration<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/943559885#Topic\/drug_contamination_prevention_&_control<\/a>> ; # Drug Contamination--prevention & control<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/943559885#Topic\/drugs_separation<\/a>> ; # Drugs--Separation<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/943559885#Topic\/pharmaceutical_preparations_analysis<\/a>> ; # Pharmaceutical Preparations--analysis<\/span>\n\u00A0\u00A0\u00A0\nschema:about<\/a> <http:\/\/experiment.worldcat.org\/entity\/work\/data\/943559885#Topic\/pharmaceutical_preparations_standards<\/a>> ; # Pharmaceutical Preparations--standards<\/span>\n\u00A0\u00A0\u00A0\nschema:bookEdition<\/a> \"1st ed.<\/span>\" ;\u00A0\u00A0\u00A0\nschema:bookFormat<\/a> bgn:PrintBook<\/a> ;\u00A0\u00A0\u00A0\nschema:contributor<\/a> <http:\/\/viaf.org\/viaf\/28916293<\/a>> ; # Karen Mills Alsante<\/span>\n\u00A0\u00A0\u00A0\nschema:contributor<\/a> <http:\/\/viaf.org\/viaf\/103624414<\/a>> ; # Satinder Ahuja<\/span>\n\u00A0\u00A0\u00A0\nschema:datePublished<\/a> \"2003<\/span>\" ;\u00A0\u00A0\u00A0\nschema:description<\/a> \"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. 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Content-negotiable representations<\/p>\n