Handbook of isolation and characterization of impurities in pharmaceuticals:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Amsterdam
Academic Press
2003
|
| Ausgabe: | 1st ed. |
| Schriftenreihe: | Separation science and technology
5 |
| Schlagworte: | |
| Online-Zugang: | Publisher description Table of contents Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | xvi, 414 p. ill. : 27 cm |
| ISBN: | 012044982X |
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 |
| 250 | |a 1st ed. | ||
| 264 | 1 | |a Amsterdam |b Academic Press |c 2003 | |
| 300 | |a xvi, 414 p. |b ill. : 27 cm | ||
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| 490 | 1 | |a Separation science and technology |v 5 | |
| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Médicaments - Purification - Guides, manuels, etc | |
| 650 | 4 | |a Médicaments - Séparation - Guides, manuels, etc | |
| 650 | 4 | |a Drug Contamination |x prevention & control |v Handbooks | |
| 650 | 4 | |a Drug Contamination |x prevention & control |v Laboratory Manuals | |
| 650 | 4 | |a Drugs |x Purification |v Handbooks, manuals, etc | |
| 650 | 4 | |a Drugs |x Separation |v Handbooks, manuals, etc | |
| 650 | 4 | |a Pharmaceutical Preparations |x analysis |v Handbooks | |
| 650 | 4 | |a Pharmaceutical Preparations |x analysis |v Laboratory Manuals | |
| 650 | 4 | |a Pharmaceutical Preparations |x standards |v Handbooks | |
| 650 | 4 | |a Pharmaceutical Preparations |x standards |v Laboratory Manuals | |
| 650 | 4 | |a Technology, Pharmaceutical |x methods |v Handbooks | |
| 650 | 4 | |a Technology, Pharmaceutical |x methods |v Laboratory Manuals | |
| 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
| _version_ | 1804132820015120384 |
|---|---|
| adam_text | HANDBOOK OF ISOLATION AND CHARACTERIZATION OF IMPURITIES IN
PHARMACEUTICALS EDITED BY SATINDER AHUJA ABUJA CONSULTING CALABASH, NC
KAREN MILLS ALSANTE PFIZER, INC. GROTON, CT J ACADEMIC PRESS ^* Y AN
IMPRINT OF ELSEVIER SCIENCE AMSTERDAM BOSTON LONDON NEW YORK OXFORD
PARIS SAN DIEGO SAN FRANCISCO SINGAPORE SYDNEY TOKYO CONTENTS PREFACE XI
CONTRIBUTORS XV I. OVERVIEW: ISOLATION AND CHARACTERIZATION OF
IMPURITIES SATINDER AHUJA I. INTRODUCTION 1 II. DESIGNATIONS OF
IMPURITIES 4 III. REGULATORY REQUIREMENTS 7 IV. SOURCES OF IMPURITIES 8
V. ANALYTICAL METHOD DEVELOPMENT 14 VI. ISOLATION METHODS 18 VII.
CHARACTERIZATION METHODS 20 VIII. CASE STUDIES 22 IX. SUMMARY 24
REFERENCES 24 2. REVIEW OF REGULATORY GUIDANCE ON IMPURITIES RADHIKA
RAJAGOPALAN I. INTRODUCTION 27 II. TYPES OF IMPURITIES*DRUG SUBSTANCE 28
III. ROLE OF COMPENDIA 30 IV. ROLE OF DRUG MASTER FILES (DMF)*TYPE II
AND IMPURITIES EVALUATION 31 V. REFERENCE STANDARDS FOR THE QUANTITATION
OF IMPURITIES AND ANALYTICAL PROCEDURES 32 VI CONTENTS VI. QUALIFICATION
OF IMPURITIES AND NEW IMPURITIES 32 VII. IMPURITIES IN DRUG PRODUCTS 33
VIII. ANALYTICAL METHODOLOGY FOR IMPURITIES IN DRUG PRODUCT 33 IX.
IMPURITIES QUANTITATION POST-APPROVAL 36 X. ROLE OF SPONSORS 36 XI.
SUMMARY 36 REFERENCES 37 3. POLYMORPHIC AND SOLVATOMORPHIC IMPURITIES
HARRY G. BRITTAIN AND ALES MEDEK I. INTRODUCTION 39 II. X-RAY
DIFFRACTION 40 III. THERMAL METHODS OF ANALYSIS 44 IV. VIBRATIONAL
SPECTROSCOPY 49 V. SOLID-STATE NUCLEAR MAGNETIC RESONANCE SPECTROMETRY
57 REFERENCES 69 4. IMPURITIES IN DRUG PRODUCTS KENNETH C. WATERMAN,
ROGER C. ADAMI, ANDJINYANG HONG I. INTRODUCTION 75 II. WATER 76 III.
PEROXIDES 78 IV. ALDEHYDES 79 V. METAL IMPURITIES 80 VI. SMALL MOLECULE
CARBOXYLIC ACIDS 82 VII. LEACHABLES/HXTRACTABLES 82 VIII. ALCOHOLS AS
IMPURITIES 83 IX. BIOLOGICAL IMPURITIES 83 X. ADDITIVES IN F.XCIPIENTS
84 XI. FINAL OBSERVATIONS 85 XII. SUMMARY 85 REFERENCES 85 5. STRATEGIES
FOR INVESTIGATION AND CONTROL OF PROCESS- AND DEGRADATION-RELATED
IMPURITIES BERNARD A. OLSEN AND STEVEN W. BAERTSCHI I. INTRODUCTION 89
II. GOALS AND STRATEGIES 91 III. PROCESS-RELATED IMPURITIES 95 IV.
DEGRADATION-RELATED IMPURITIES 102 V. SUMMARY AND CONCLUSIONS 115
REFERENCES 116 CONTENTS VII 6. REFERENCE STANDARDS PAUL A.CULBERTAND
BRUCE D.JOHNSON I. INTRODUCTION 119 II. DEFINITIONS 120 III. LIFE CYCLE
121 IV. GOVERNANCE 125 V. QUALIFICATION PROCESS 127 VI. SUMMARY 139
REFERENCES 139 7. SAMPLE SELECTION FOR ANALYTICAL METHOD DEVELOPMENT
HUGH J. CLARKE AND KENNETH J. NORRIS I. INTRODUCTION 145 II. COMPONENTS
OF THE KEY PREDICTIVE SAMPLE SET (KPSS) 147 III. STEREOISOMERS 147 IV.
MATRIX COMPONENTS 150 V. PROCESS-RELATED IMPURITIES (PRIS) 150 VI.
PURPOSEFUL DEGRADATION SAMPLES 152 VII. STABILITY SAMPLES 155 VIII.
PHASE-SOLUBILITY ANALYSIS 156 IX. SAMPLE SELECTION STRATEGIES 159 X.
SUMMARY 162 GLOSSARY 162 REFERENCES 163 8. SAMPLE PREPARATION METHODS
FOR THE ANALYSIS OF PHARMACEUTICAL MATERIALS DAVID T ROSSI AND KENNETH
G. MILLER I. INTRODUCTION 166 II. SOLID-PHASE EXTRACTION (SPF) 166 III.
LIQUID-LIQUID EXTRACTION (LLE) 174 IV. SUPERCRITICAL FLUID EXTRACTION
(SFE) 181 V. ACCELERATED SOLVENT EXTRACTION (ASF ) 189 VI.
CENTRIFUGATION 194 VII. FILTRATION 195 VIII. SUMMARY 199 REFERENCES 199
VLIL CONTENTS 9. ISOLATION METHODS I: THIN-LAYER CHROMATOGRAPHY PAMELA
M.GORMAN AND HONG JIANG I. INTRODUCTION TO THIN-LAYER CHROMATOGRAPHY
(TLC) 203 II. TLC APPLICATIONS IN PHARMACEUTICAL INDUSTRY 206 III. TLC
METHOD DEVELOPMENT AND VALIDATION 207 IV. IMPURITY ISOLATION AND
CHARACTERIZATION BY TLC 221 REFERENCES 228 10. ISOLATION METHODS II:
COLUMN CHROMATOGRAPHY MARKGUINN, RONALD BATES, BENJAMIN HRITZKO.TERI
SHANKLIN, GLENN WILCOX, AND SAM GUHAN I. INTRODUCTION 231 II. BACKGROUND
232 III. STATIONARY PHASES 233 IV. EQUIPMENT 237 V. SCREENING 240 VI.
DEVELOPMENT OF PREPARATIVE METHOD 244 VII. SCALEUP OF PREPARATIVE METHOD
246 SUMMARY 248 REFERENCES 248 11. MASS SPECTRAL CHARACTERIZATION DAVID
J. BURINSKYAND FENG WANG I. INTRODUCTION 249 II. RELEVANCE OF IMPURITY
CHARACTERIZATION 252 III. THE COUPLING OF LIQUID-PHASE SEPARATIONS AND
MASS SPECTROMETERS 259 IV. ION FORMATION 264 V. ANALYZERS 273 VI. ION
STRUCTURE INTERROGATION 277 VII. DATA ACQUISITION AND INTERPRETATION 282
VIII. APPLICATIONS 286 IX. CONCLUSIONS 288 X. SUMMARY 289 REFERENCES 290
CONTENTS IX 12. NMR CHARACTERIZATION OF IMPURITIES LINDA L LOHR, ANDREW
J. JENSEN, AND THOMAS R. SHARP I. INTRODUCTION TO NUCLEAR MAGNETIC
RESONANCE (NMR) 301 II. INFORMATION GATHERING 304 III. SAMPLE
PREPARATION FOR NMR 305 IV. SAMPLE PREPARATION FOR LC-NMR 307 V. NMR
INSTRUMENTATION 309 VI. NMR EXPERIMENTS 314 VII. CHOOSING AN EXPERIMENT
SET 324 VIII. DATA INTERPRETATION 325 IX. FINAL STEPS 334 X. SUMMARY 336
REFERENCES 337 13. HYPHENATED CHARACTERIZATIONTECHNIQUES THOMAS N.
FEINBERG I. INTRODUCTION 341 II. EXPERIMENTAL EXAMPLES 350 III.
CONCLUSIONS 356 REFERENCES 357 14. SOLVING IMPURITY/DEGRADATION
PROBLEMS: CASE STUDIES KAREN M. ALSANTE,TODD D HATAJIK, LINDA L. LOHR,
DINOS SANTAFIANOS, AND THOMAS R. SHARP I. INTRODUCTION AND BACKGROUND
361 II. CASE STUDIES 368 III. SUMMARY AND CONCLUSIONS 398
APPENDIX*LESSONS LEARNED 398 REFERENCES 399 INDEX 401
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| id | DE-604.BV019377435 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T19:58:53Z |
| institution | BVB |
| isbn | 012044982X |
| language | English |
| lccn | 2003040309 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-012840813 |
| oclc_num | 51437837 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM DE-20 |
| owner_facet | DE-19 DE-BY-UBM DE-20 |
| physical | xvi, 414 p. ill. : 27 cm |
| publishDate | 2003 |
| publishDateSearch | 2003 |
| publishDateSort | 2003 |
| publisher | Academic Press |
| record_format | marc |
| series | Separation science and technology |
| series2 | Separation science and technology |
| spelling | Handbook of isolation and characterization of impurities in pharmaceuticals edited by Satinder Ahuja, Karen Mills Alsante 1st ed. Amsterdam Academic Press 2003 xvi, 414 p. ill. : 27 cm txt rdacontent n rdamedia nc rdacarrier Separation science and technology 5 Includes bibliographical references and index Médicaments - Purification - Guides, manuels, etc Médicaments - Séparation - Guides, manuels, etc Drug Contamination prevention & control Handbooks Drug Contamination prevention & control Laboratory Manuals Drugs Purification Handbooks, manuals, etc Drugs Separation Handbooks, manuals, etc Pharmaceutical Preparations analysis Handbooks Pharmaceutical Preparations analysis Laboratory Manuals Pharmaceutical Preparations standards Handbooks Pharmaceutical Preparations standards Laboratory Manuals Technology, Pharmaceutical methods Handbooks Technology, Pharmaceutical methods Laboratory Manuals Ahuja, Satinder Sonstige oth Alsante, Karen Mills Sonstige oth Separation science and technology 5 (DE-604)BV011987396 5 http://www.loc.gov/catdir/description/els031/2003040309.html Publisher description http://www.loc.gov/catdir/toc/els031/2003040309.html Table of contents GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=012840813&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Handbook of isolation and characterization of impurities in pharmaceuticals Separation science and technology Médicaments - Purification - Guides, manuels, etc Médicaments - Séparation - Guides, manuels, etc Drug Contamination prevention & control Handbooks Drug Contamination prevention & control Laboratory Manuals Drugs Purification Handbooks, manuals, etc Drugs Separation Handbooks, manuals, etc Pharmaceutical Preparations analysis Handbooks Pharmaceutical Preparations analysis Laboratory Manuals Pharmaceutical Preparations standards Handbooks Pharmaceutical Preparations standards Laboratory Manuals Technology, Pharmaceutical methods Handbooks Technology, Pharmaceutical methods Laboratory Manuals |
| 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 | Médicaments - Purification - Guides, manuels, etc Médicaments - Séparation - Guides, manuels, etc Drug Contamination prevention & control Handbooks Drug Contamination prevention & control Laboratory Manuals Drugs Purification Handbooks, manuals, etc Drugs Separation Handbooks, manuals, etc Pharmaceutical Preparations analysis Handbooks Pharmaceutical Preparations analysis Laboratory Manuals Pharmaceutical Preparations standards Handbooks Pharmaceutical Preparations standards Laboratory Manuals Technology, Pharmaceutical methods Handbooks Technology, Pharmaceutical methods Laboratory Manuals |
| topic_facet | Médicaments - Purification - Guides, manuels, etc Médicaments - Séparation - Guides, manuels, etc Drug Contamination prevention & control Handbooks Drug Contamination prevention & control Laboratory Manuals Drugs Purification Handbooks, manuals, etc Drugs Separation Handbooks, manuals, etc Pharmaceutical Preparations analysis Handbooks Pharmaceutical Preparations analysis Laboratory Manuals Pharmaceutical Preparations standards Handbooks Pharmaceutical Preparations standards Laboratory Manuals Technology, Pharmaceutical methods Handbooks Technology, Pharmaceutical methods Laboratory Manuals |
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| volume_link | (DE-604)BV011987396 |
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