| Edition |
1st ed. |
| Description |
1 online resource (xvi, 414 pages) : illustrations |
|
text txt rdacontent |
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computer c rdamedia |
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online resource cr rdacarrier |
| Series |
Separation science and technology ; v. 5 |
|
Separation science and technology (San Diego, Calif.) ; v. 5.
|
| 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. |
| 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. |
| Bibliography |
Includes bibliographical references and index. |
| Note |
Print version record. |
| Subject |
Drugs -- Purification -- Handbooks, manuals, etc.
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Drugs -- Separation -- Handbooks, manuals, etc.
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Pharmaceutical Preparations -- analysis |
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Drug Contamination -- prevention & control |
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Pharmaceutical Preparations -- standards |
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Technology, Pharmaceutical -- methods |
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Médicaments -- Purification -- Guides, manuels, etc.
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Médicaments -- Séparation -- Guides, manuels, etc.
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MEDICAL -- Drug Guides.
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MEDICAL -- Pharmacology.
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MEDICAL -- Pharmacy.
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MEDICAL -- Nursing -- Pharmacology.
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Drugs -- Purification
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Drugs -- Separation
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| Genre/Form |
Electronic books.
|
|
Handbook |
|
Laboratory Manual |
|
handbooks.
|
|
Laboratory manuals
|
|
Handbooks and manuals
|
|
Handbooks and manuals.
|
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Laboratory manuals.
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Guides et manuels.
|
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Manuels de laboratoire.
|
| Added Author |
Ahuja, Satinder, 1933- Editor.
|
|
Alsante, Karen Mills. Editor.
|
| Other Form: |
Print version: Handbook of isolation and characterization of impurities in pharmaceuticals. 1st ed. Amsterdam ; Boston : Academic Press, 2003 012044982X 9780120449828 (DLC) 2003040309 (OCoLC)51437837 |
| ISBN |
9780120449828 |
|
012044982X |
|
9780080507767 (electronic bk.) |
|
008050776X (electronic bk.) |
|
128102077X |
|
9781281020772 |
| Standard No. |
AU@ 000056736203 |
|
CHBIS 005835090 |
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CHVBK 168454114 |
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DEBBG BV039832663 |
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DEBBG BV042308298 |
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DEBSZ 316164119 |
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DEBSZ 405296428 |
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NZ1 12434124 |
|
