Analysis of drug impurities
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| Format: | Buch |
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| Sprache: | English |
| Veröffentlicht: |
Oxford
Blackwell
2007
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| Schriftenreihe: | Analytical chemistry series
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| Schlagworte: | |
| Online-Zugang: | Contributor biographical information Publisher description Table of contents only Table of contents Inhaltsverzeichnis |
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| 245 | 1 | 0 | |a Analysis of drug impurities |c ed. by Richard J. Smith ... |
| 264 | 1 | |a Oxford |b Blackwell |c 2007 | |
| 300 | |a IX, 275 S. |b Ill., graph. Darst. |c 24 cm | ||
| 336 | |b txt |2 rdacontent | ||
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| 490 | 0 | |a Analytical chemistry series | |
| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Drugs |x Analysis | |
| 650 | 4 | |a Drug Contamination |x prevention & control | |
| 650 | 4 | |a Pharmaceutical Preparations |x analysis | |
| 650 | 4 | |a Chemistry, Pharmaceutical |x methods | |
| 700 | 1 | |a Smith, Richard J. |d 1951- |e Sonstige |0 (DE-588)124449484 |4 oth | |
| 856 | 4 | |u http://www.loc.gov/catdir/enhancements/fy0802/2007280433-b.html |3 Contributor biographical information | |
| 856 | 4 | |u http://www.loc.gov/catdir/enhancements/fy0802/2007280433-d.html |3 Publisher description | |
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Datensatz im Suchindex
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| adam_text | ANALYSIS OF DRUG IMPURITIES EDITED BY RICHARD J. SMITH GLAXOSMITHKLINE
RESEARCH AND DEVELOPMENT TONBRIDGE, UK AND MICHAEL L. WEBB
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT STEVENAGE, UK BLACKWELL
PUBLISHING II(-( I . L ~.,R ~,( .-- , CONTENTS PREFACE LIST OF
CONTRIBUTORS 1. ORGANIC IMPURITIES IN DRUG SUBSTANCE: ORIGIN, CONTROL,
AND MEASUREMENT LINDA NG, GEORGE LUNN, AND PATRICK FAUSTINO I .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 I .3.1 CONTROL OF
RESIDUAL SOLVENTS 1.3.2 CONTROL OF SYNTHETIC IMPURITIES 1.3.3 CONTROL OF
IMPURITIES IN BIOLOGICAL AND BOTANICAL PRODUCTS I .3.4 PURIFICATION
PROCESSES I .3.5 CONTROL OF IMPURITIES FROM PACKAGING I .3.6 CONTROL OF
CONTAMINATION IMPURITIES I .3.7 CONTROL OF DEGRADANTS ON STABILITY I .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
DAVID P. ELDER 2.1 INTRODUCTION 2.2 ANALYTICAL METHODOLOGY 2.3
DRUG-EXCIPIENT COMPATIBILITY EXPERIMENTAL DESIGN 2.4 DEGRADATION
MECHANISMS XL XII 1 I I 2 2 3 3 4 4 5 7 9 10 11 I I 11 12 13 IS 16
19 19 21 21 22 24 25 * VL CONTENTS 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 IMPACT OF PROCESSING ON PHOTOSTABILITY
2.11 MISCELLANEOUS REACTIONS 2.12 CONTAINER-CLOSURE SYSTEMS REFERENCES
27 30 31 32 34 36 38 40 43 3. STEREOCHEMICAL IMPURITIES MARK R. HADLEY
3.1 INTRODUCTION 3.2 SEPARATION TECHNIQUES: DIRECT RESOLUTION 3.2.1 HPLC
USING CSPS 3.2.2 HPLC USING CHIRAL MOBILE-PHASE ADDITIVES 3.2.3
CAPILLARY ELECTROPHORESIS USING CHIRAL SELECTORS 3.2.4 SUPERCRITICAL
FLUID CHROMATOGRAPHY USING CHIRAL STATIONARY PHASES 3.2.5 GAS
CHROMATOGRAPHY USING CHIRAL STATIONARY PHASES 3.3 SEPARATION TECHNIQUES:
INDIRECT RESOLUTION 3.4 NON-SEPARATION TECHNIQUES 3.4.1 CHIROPTICAL
SPECTROSCOPY 3.4.2 NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY 3.5
CONCLUSIONS ACKNOWLEDGEMENTS REFERENCES 4. LOW-LEVEL MEASUREMENT OF
POTENT TOXINS PETER W. SKETT 4.1 INTRODUCTION 4.2 CLASSES OF GENOTOXIC
IMPURITY 4.2.1 ALKYLATING AGENTS 4.2.2 REACTIVE AMINES 4.2.3 FUSED
TRICYCLICS 4.2.4 SUBSTITUTED PURINES AND PYRIMIDINES 4.2.5
HYDROPEROXIDES 4.3 THE ANALYTICAL CHALLENGE OF GENETIC TOXINS 4.4 GAS
CHROMATOGRAPHY 4.4.1 SAMPLE INTRODUCTION TECHNIQUES 4.4.2 I)ETECTORS 4.5
HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY 4.5.1 SEPARATION MODES 4.5.2
DETECTION TECHNIQUES 47 47 49 50 61 63 67 69 71 71 71 73 77 77 77 82 82
84 85 86 86 86 86 86 87 87 91 96 96 98 5. A SYSTEMATIC APPROACH TO
IMPURITY IDENTIFICATION 124 GARY E. MARTIN 5.1 INTRODUCTION 124 5.1 .1
STRUCTURE ELUCIDATION GROUP ORGANIZATIONAL MODELS 125 5.1.2 WHETHER OR
NOT TO ISOLATE AND IDENTIFY AN IMPURITY OR DEGRADANT 126 5.1 .3 TIME
LINES FOR IMPURITY/DEGRADANT IDENTIFICATION 128 5.1.4 IMPURITIES VS
DEGRADATION PRODUCTS 130 5.2 ISOLATION AND IDENTIFICATION OF IMPURITIES
AND DEGRADANTS 132 5.2.1 PREPARATIVE CHROMATOGRAPHY 132 5.2.2
SPECTROSCOPIC DATA FROM VARIOUS TECHNIQUES 132 5.2.3 DATA INTEGRATION
136 5.3 IMPURITY AND DEGRADANT CHARACTERIZATION STUDIES 136 5.3.1
CHARACTERIZATION OF AN UNSTABLE PROCESS IMPURITY IN THE PROTEASE
INHIBITOR TIPRANAVIR 137 5.3.2 CHARACTERIZATION OF AN IMPURITY OF
PIRLIMYCIN FORMED BY CYCLIZATION 140 5.3.3 STRUCTURAL CHARACTERIZATION
OF DEGRADATION PRODUCTS OF AN ALKALOID SAMPLE SUBJECT TO LONG-TERM
STORAGE IN DMSO 143 CONTENTS 4.6 SUPERCRITICAL FLUID CHROMATOGRAPHY 4.7
THIN-LAYER CHROMATOGRAPHY 4.8 SAMPLE PRE-CONCENTRATION 4.8.1
LIQUID-LIQUID EXTRACTION 4.8.2 SOLID-PHASE EXTRACTION 4.8.3 SOLID-PHASE
MICROEXTRACTION 4.8.4 LIQUID-PHASE MICROEXTRACTION 4.9 OTHER TECHNIQUES
4.9.1 ELECTROCHEMICAL MEASUREMENTS 4.9.2 DERIVATISATION METHODS 4.10
ADAPTING ANALYTICAL METHODS FROM FIELDS BEYOND PHARMACEUTICALS
IMPURITIES ANALYSIS 4.10.1 ANTINEOPLASTIC AGENTS 4.10.2 OTHER FIELDS
4.11 VALIDATION OF TRACE ANALYTICAL METHODS 4.11 .1 SENSITIVITY 4.11.2
SPECIFICITY 4.11.3 ACCURACY 4.11.4 SOLUTION STABILITY 4.11 .5 LINEARITY
AND PRECISION 4.12 CONCLUSIONS REFERENCES ** VII 103 103 104 104 105 105
105 107 107 107 109 110 111 III 117 117 117 118 118 118 119 * * * V1LL
CONTENTS 5.3.4 THE IMPACT OF EXPERIMENT SELECTION ON THE ELUCIDATION OF
THE STRUCTURE OF A COMPLEX THERMAL DEGRADANT 5.4 CONCLUSIONS REFERENCES
148 150 152 6. THE USE OF CHROMATOGRAPHY AND ONLINE STRUCTURE
ELUCIDATI.ON USING SPECTROSCOPY JANET HAMMOND AND IAN JONES 6.1
INTRODUCTION TO LC-MS 6.2 API TECHNIQUES 6.2.1 ELECTROSPRAY PROCESS
6.2.2 APCI 6.2.3 ATMOSPHERIC PRESSURE PHOTO IONISATION 6.2.4 EST, APCI
OR APPL? 6.3 PRACTICAL CONSIDERATIONS 6.3.1 ELUENT CONSIDERATIONS 6.3.2
FLOW RATE AND INTERFACING CONSIDERATIONS 6.3.3 DATA PROCESSING 6.4
STRUCTURAL ELUCIDATION OF UNKNOWNS 6.4.1 GENERAL INTERPRETATION
CONSIDERATIONS 6.4.2 RECOGNISING MULTIPLY CHARGED SPECIES 6.4.3 USING
ADDUCT IONS 6.4.4 USE OF IN-SOURCE FRAGMENTATION 6.4.5 USING TANDEM
MS-MS TECHNIQUES 6.4.6 ACCURATE MASS MEASUREMENTS 6.4.7 HYDROGEN
/DEUTERIUM EXCHANGE 6.5 A PRACTICAL EXAMPLE 6.6 LC METHOD DEVELOPMENT
AND VALIDATION 6.7 ONLINE NMR SPECTROSCOPY 6.7.1 LC-NMR EXPERIMENTAL
SET-UP 6.7.2 LC-NMR SOLVENTS 6.7.3 SOLVENT SUPPRESSION 6.7.4 LC-NMR
OPTIMISATION 6.7.5 MODES OF LC-NMR AND THEIR APPLICATION 6.7.6 ENHANCING
THE SENSITIVITY OF LC-NMR 6.7.7 COUPLING OF NMR TO OTHER SEPARATION
TECHNIQUES 6.7.8 CONSIDERATIONS FOR ONLINE ANALYSIS REFERENCES 7.
PREPARATIVE ISOLATION OF IMPURITIES GERALD TERJLOTH 7.1 INTRODUCTION 7.2
SCOPE DEFINITION 156 156 157 157 158 159 160 162 162 164 165 166 166 167
169 171 172 181 183 186 188 190 191 192 192 193 196 200 206 209 212 215
215 215 CONTENTS 7.3 TOOLBOX 7.3.1 PREPARATIVE HPLC(!MS) 7.3.2 SFC 7.3.3
PREPARATI VE TLC, FLASH CHROMATOGRAPHY 7.3.4 CONTINUOUS CHROMATOGRAPHY
7.3.5 SOLUBILITY DETERMINATION 7.3.6 STABILITY DETERMINATION 7.4 METHOD
DEVELOPMENT: SCOUTING AND SCALE-UP 7.4.1 HPLC 7.4.2 SFC 7.4.3 SCALE-UP
7.4.4 ISOLATION 7.5 PERFORMING THE TASK ACKNOWLEDGMENTS REFERENCES 8.
THE IMPACT OF CONTINUOUS PROCESSING FRANK COTTEE 8.1 CONTEXT - A BRIEF
HISTORY OF DRUG IMPURITY ANALYSIS 8.1 .1 STRUCTURAL CHARACTERISATION 8.1
.2 SEPARATIONS 8.1 .3 THE USES OF DRUG IMPURITY DATA 8.2 CONTINUOUS
PROCESSING 8.2.1 BATCH PROCESSING 8.2.2 CONTINUOUS PROCESSING 8.2.3
COMPARISON WITH OTHER INDUSTRIES 8.3 PROCESS ANALYTICAL TECHNOLOGY 8.4
ANALYTICAL STRATEGIES 8.4.1 BATCH PROCESSES 8.4.2 CONTINUOUS PROCESSES
8.5 PROCESS ANALYSIS 8.5.1 UV/VISIBLE SPECTROSCOPY 8.5.2 INFRARED (IR)
SPECTROSCOPY 8.5.3 RAMAN SPECTROSCOPY 8.5.4 NIR SPECTROSCOPY 8.5.5 NMR
SPECTROSCOPY 8.5.6 MASS SPECTROMETRY 8.5.7 ULTRASOUND 8.5.8
CHROMATOGRAPHY 8.5.9 OTHER ONLINE ANALYTICAL EXAMPLES 8.6 CHEMOMETRICS
8.7 THE FUTURE REFERENCES INDEX * IX 219 220 221 221 222 222 222 223 223
225 226 230 231 233 233 235 235 235 237 237 238 238 240 243 243 246 246
248 250 252 253 254 256 258 259 260 261 262 263 265 265 273
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| illustrated | Illustrated |
| indexdate | 2025-02-03T17:14:18Z |
| institution | BVB |
| isbn | 1405133589 9781405133586 |
| language | English |
| lccn | 2007280433 |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-016511180 |
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| physical | IX, 275 S. Ill., graph. Darst. 24 cm |
| publishDate | 2007 |
| publishDateSearch | 2007 |
| publishDateSort | 2007 |
| publisher | Blackwell |
| record_format | marc |
| series2 | Analytical chemistry series |
| spellingShingle | Analysis of drug impurities Drugs Analysis Drug Contamination prevention & control Pharmaceutical Preparations analysis Chemistry, Pharmaceutical methods |
| title | Analysis of drug impurities |
| title_auth | Analysis of drug impurities |
| title_exact_search | Analysis of drug impurities |
| title_full | Analysis of drug impurities ed. by Richard J. Smith ... |
| title_fullStr | Analysis of drug impurities ed. by Richard J. Smith ... |
| title_full_unstemmed | Analysis of drug impurities ed. by Richard J. Smith ... |
| title_short | Analysis of drug impurities |
| title_sort | analysis of drug impurities |
| topic | Drugs Analysis Drug Contamination prevention & control Pharmaceutical Preparations analysis Chemistry, Pharmaceutical methods |
| topic_facet | Drugs Analysis Drug Contamination prevention & control Pharmaceutical Preparations analysis Chemistry, Pharmaceutical methods |
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