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Record Nr. |
UNINA9910830641003321 |
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Titolo |
Analysis of drug impurities [[electronic resource] /] / edited by Richard J. Smith and Michael L. Webb |
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Pubbl/distr/stampa |
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Oxford ; ; Ames, Iowa, : Blackwell, 2007 |
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ISBN |
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1-281-32024-2 |
9786611320249 |
0-470-98874-6 |
0-470-99422-3 |
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Descrizione fisica |
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1 online resource (290 p.) |
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Collana |
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Analytical chemistry series |
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Altri autori (Persone) |
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SmithRichard J |
WebbMichael L |
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Disciplina |
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Soggetti |
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Drugs - Analysis |
Materia medica |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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Analysis of Drug Impurities; Contents; Preface; List of contributors; 1 Organic impurities in drug substance: origin, control, and measurement; 1.1 Introduction; 1.2 Origin of impurities; 1.2.1 Process impurities; 1.2.2 Degradation impurities; 1.2.3 Contamination impurities; 1.2.4 Other impurities; 1.3 Control of drug substance impurities; 1.3.1 Control of residual solvents; 1.3.2 Control of synthetic impurities; 1.3.3 Control of impurities in biological and botanical products; 1.3.4 Purification processes; 1.3.5 Control of impurities from packaging; 1.3.6 Control of contamination impurities |
1.3.7 Control of degradants on stability1.4 Measurement of drug substance impurities; 1.4.1 HPLC; 1.4.2 GC; 1.4.3 CE; 1.4.4 General considerations; 1.5 Conclusions; Disclaimer; References; 2 Organic impurities in drug products: origin, control and measurement; 2.1 Introduction; 2.2 Analytical methodology; 2.3 Drug-excipient compatibility experimental design; 2.4 Degradation mechanisms; 2.5 Excipients' role in drug product destabilisation; 2.6 Processing as a source of moisture; 2.7 Hydrolysis; 2.8 Oxidation; 2.9 Photolysis; 2.10 |
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