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Handbook of isolation and characterization of impurities in pharmaceuticals / edited by Ahuja Satinder, & Karen Mills Alsante

Contributor(s): Satinder, Ahuja | Alsante, Karen MillsMaterial type: TextTextLanguage: English Publication details: New Delhi : Elsevier, c2005. Description: xvi, 414 p. : ill. ; 24cmISBN: 012044982X; 9788181479822; 9780120449828; 9780080507767; 8181479823; 008050776XSubject(s): Pharmaceutical Preparations | Drug Contamination | Drugs-Analysis ContaminationTechnology | PharmacyDDC classification: 615.1901 Online resources: WorldCat details | E-book Fulltext
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. TOC
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 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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Item type Current library Collection Call number Copy number Status Date due Barcode Item holds
E-Book E-Book Dr. S. R. Lasker Library, EWU
E-book
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) Not for loan
Text Text Dr. S. R. Lasker Library, EWU
Reserve Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-1 Not For Loan 21337
Text Text Dr. S. R. Lasker Library, EWU
Reserve Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-2 Not For Loan 21391
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-3 Available 21392
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-4 Available 21393
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-5 Available 21394
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-6 Available 21395
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-7 Available 21396
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-8 Available 21397
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-9 Available 21398
Text Text Dr. S. R. Lasker Library, EWU
Circulation Section
Non-fiction 615.1901 HAN 2005 (Browse shelf(Opens below)) C-10 Available 21399
Total holds: 0

Includes Bibliographical References and Index.

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. TOC

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.

Pharmacy

Abdul Gani

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