Handbook of isolation and characterization of impurities in pharmaceuticals:
Gespeichert in:
Format: | Elektronisch E-Book |
---|---|
Sprache: | English |
Veröffentlicht: |
Amsterdam
Academic Press
2003
|
Ausgabe: | 1st ed |
Schriftenreihe: | Separation science and technology (San Diego, Calif.)
v. 5 |
Schlagworte: | |
Online-Zugang: | Volltext |
Beschreibung: | 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 Includes bibliographical references and index |
Beschreibung: | 1 Online-Ressource (xvi, 414 p.) |
ISBN: | 9780120449828 012044982X 9780080507767 008050776X |
Internformat
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245 | 1 | 0 | |a Handbook of isolation and characterization of impurities in pharmaceuticals |c edited by Satinder Ahuja, Karen Mills Alsante |
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264 | 1 | |a Amsterdam |b Academic Press |c 2003 | |
300 | |a 1 Online-Ressource (xvi, 414 p.) | ||
336 | |b txt |2 rdacontent | ||
337 | |b c |2 rdamedia | ||
338 | |b cr |2 rdacarrier | ||
490 | 0 | |a Separation science and technology (San Diego, Calif.) |v v. 5 | |
500 | |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. 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 | ||
500 | |a Includes bibliographical references and index | ||
650 | 7 | |a Handbooks, manuals, etc |2 fast | |
650 | 4 | |a Médicaments / Purification / Guides, manuels, etc | |
650 | 4 | |a Médicaments / Séparation / Guides, manuels, etc | |
650 | 7 | |a MEDICAL / Drug Guides |2 bisacsh | |
650 | 7 | |a MEDICAL / Pharmacology |2 bisacsh | |
650 | 7 | |a MEDICAL / Pharmacy |2 bisacsh | |
650 | 7 | |a MEDICAL / Nursing / Pharmacology |2 bisacsh | |
650 | 7 | |a Drugs / Purification |2 fast | |
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650 | 4 | |a Pharmaceutical Preparations / analysis / Handbooks | |
650 | 4 | |a Pharmaceutical Preparations / analysis / Laboratory Manuals | |
650 | 4 | |a Medizin | |
650 | 4 | |a Drugs |x Purification |v Handbooks, manuals, etc | |
650 | 4 | |a Drugs |x Separation |v Handbooks, manuals, etc | |
700 | 1 | |a Ahuja, Satinder |e Sonstige |4 oth | |
700 | 1 | |a Alsante, Karen Mills |e Sonstige |4 oth | |
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Datensatz im Suchindex
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any_adam_object | |
building | Verbundindex |
bvnumber | BV042308298 |
collection | ZDB-33-ESD ZDB-33-EBS |
ctrlnum | (OCoLC)162129555 (DE-599)BVBBV042308298 |
dewey-full | 615/.19 |
dewey-hundreds | 600 - Technology (Applied sciences) |
dewey-ones | 615 - Pharmacology and therapeutics |
dewey-raw | 615/.19 |
dewey-search | 615/.19 |
dewey-sort | 3615 219 |
dewey-tens | 610 - Medicine and health |
discipline | Medizin |
edition | 1st ed |
format | Electronic eBook |
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illustrated | Not Illustrated |
indexdate | 2024-07-10T01:17:58Z |
institution | BVB |
isbn | 9780120449828 012044982X 9780080507767 008050776X |
language | English |
oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-027745290 |
oclc_num | 162129555 |
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owner_facet | DE-1046 |
physical | 1 Online-Ressource (xvi, 414 p.) |
psigel | ZDB-33-ESD ZDB-33-EBS FAW_PDA_ESD FLA_PDA_ESD |
publishDate | 2003 |
publishDateSearch | 2003 |
publishDateSort | 2003 |
publisher | Academic Press |
record_format | marc |
series2 | Separation science and technology (San Diego, Calif.) |
spelling | Handbook of isolation and characterization of impurities in pharmaceuticals edited by Satinder Ahuja, Karen Mills Alsante 1st ed Amsterdam Academic Press 2003 1 Online-Ressource (xvi, 414 p.) txt rdacontent c rdamedia cr rdacarrier Separation science and technology (San Diego, Calif.) v. 5 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 Includes bibliographical references and index Handbooks, manuals, etc fast Médicaments / Purification / Guides, manuels, etc Médicaments / Séparation / Guides, manuels, etc MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Drugs / Purification fast Drugs / Separation fast Pharmaceutical Preparations / analysis / Handbooks Pharmaceutical Preparations / analysis / Laboratory Manuals Medizin Drugs Purification Handbooks, manuals, etc Drugs Separation Handbooks, manuals, etc Ahuja, Satinder Sonstige oth Alsante, Karen Mills Sonstige oth http://www.sciencedirect.com/science/book/9780120449828 Verlag Volltext |
spellingShingle | Handbook of isolation and characterization of impurities in pharmaceuticals Handbooks, manuals, etc fast Médicaments / Purification / Guides, manuels, etc Médicaments / Séparation / Guides, manuels, etc MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Drugs / Purification fast Drugs / Separation fast Pharmaceutical Preparations / analysis / Handbooks Pharmaceutical Preparations / analysis / Laboratory Manuals Medizin Drugs Purification Handbooks, manuals, etc Drugs Separation Handbooks, manuals, etc |
title | Handbook of isolation and characterization of impurities in pharmaceuticals |
title_auth | Handbook of isolation and characterization of impurities in pharmaceuticals |
title_exact_search | Handbook of isolation and characterization of impurities in pharmaceuticals |
title_full | Handbook of isolation and characterization of impurities in pharmaceuticals edited by Satinder Ahuja, Karen Mills Alsante |
title_fullStr | Handbook of isolation and characterization of impurities in pharmaceuticals edited by Satinder Ahuja, Karen Mills Alsante |
title_full_unstemmed | Handbook of isolation and characterization of impurities in pharmaceuticals edited by Satinder Ahuja, Karen Mills Alsante |
title_short | Handbook of isolation and characterization of impurities in pharmaceuticals |
title_sort | handbook of isolation and characterization of impurities in pharmaceuticals |
topic | Handbooks, manuals, etc fast Médicaments / Purification / Guides, manuels, etc Médicaments / Séparation / Guides, manuels, etc MEDICAL / Drug Guides bisacsh MEDICAL / Pharmacology bisacsh MEDICAL / Pharmacy bisacsh MEDICAL / Nursing / Pharmacology bisacsh Drugs / Purification fast Drugs / Separation fast Pharmaceutical Preparations / analysis / Handbooks Pharmaceutical Preparations / analysis / Laboratory Manuals Medizin Drugs Purification Handbooks, manuals, etc Drugs Separation Handbooks, manuals, etc |
topic_facet | Handbooks, manuals, etc Médicaments / Purification / Guides, manuels, etc Médicaments / Séparation / Guides, manuels, etc MEDICAL / Drug Guides MEDICAL / Pharmacology MEDICAL / Pharmacy MEDICAL / Nursing / Pharmacology Drugs / Purification Drugs / Separation Pharmaceutical Preparations / analysis / Handbooks Pharmaceutical Preparations / analysis / Laboratory Manuals Medizin Drugs Purification Handbooks, manuals, etc Drugs Separation Handbooks, manuals, etc |
url | http://www.sciencedirect.com/science/book/9780120449828 |
work_keys_str_mv | AT ahujasatinder handbookofisolationandcharacterizationofimpuritiesinpharmaceuticals AT alsantekarenmills handbookofisolationandcharacterizationofimpuritiesinpharmaceuticals |