This is a comprehensive source of information on the application of ion chromatography (IC) in the analysis of pharmaceutical drugs and biologicals. This book, with contributors from academia, pharma, the biotech industry, and instrument manufacturing, presents the different perspectives, experience, and expertise of the thought leaders of IC in a comprehensive manner. It explores potential IC applications in different aspects of product development and quality control testing. In addition, an appendix section gives information on critical physical and chromatographic parameters related to IC and information on current manufacturers of IC systems, columns, and other components.
Recenzijas
This book is a model of what can be achieved with a well-developed plan and the support of expert authors. (Chromatographia, 2012)
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ix | |
| Preface |
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xi | |
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PART I PRINCIPLES, MECHANISM, AND INSTRUMENTATION |
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1 | (134) |
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1 ION Chromatography--Principles and Applications |
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3 | (20) |
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2 Retention Processes in Ion-Exclusion Chromatography: A New Perspective |
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23 | (26) |
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3 Pulsed Electrochemical Detection in Ion Chromatography |
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49 | (42) |
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4 Suppressor Design and Detection for Ion Chromatography |
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91 | (16) |
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5 Modelling and Optimization of Ion Chromatographic Separations of Pharmaceutically Relevant Organic Ions |
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107 | (28) |
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PART II PHARMACEUTICAL APPLICATIONS |
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135 | (186) |
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6 Ion Chromatography in Pharmaceutical Drug Analysis |
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137 | (22) |
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7 Analysis for Impurities by Ion Chromatography |
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159 | (16) |
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8 Ion Chromatography Analysis of Aminoglycoside Antibiotics |
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175 | (18) |
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9 Use of Cation-Exchange Ion Chromatography in the Analysis of Pharmaceuticals |
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193 | (28) |
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10 Comprehensive Approaches for Measurement of Active Pharmaceutical Ingredients, Counter-Ions, and Excipients Using HPLC with Charged Aerosol Detection |
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221 | (16) |
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11 High Performance Ion Chromatographic Analysis of Cholinergic Compounds: Carbachol and Bethanechol, and Associated Degradation Products |
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237 | (10) |
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12 Ion Chromatographic Analysis of Pharmaceuticals for Authenticity and Adulteration |
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247 | (12) |
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13 Ion Chromatography of Drug Product Counter-Ions and Other Ions in Drug Products |
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259 | (12) |
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14 Sample Preparation Techniques in Ion Chromatography for Pharmaceutical Applications |
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271 | (14) |
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15 Validation of Ion Chromatographic Methods |
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285 | (24) |
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16 Pharmacopeial Applications of Ion Chromatography |
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309 | (12) |
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PART III BIOTECHNOLOGY APPLICATIONS |
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321 | (72) |
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17 Glycan Analysis by High Performance Anion Exchange Chromatography with Pulsed Amperometric Detection |
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323 | (16) |
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18 Monosaccharide Analysis of Glycoproteins by High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection |
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339 | (12) |
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19 Two-Dimensional Ion Chromatography for Simultaneous Determination of Amino Acids and Carbohydrates |
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351 | (14) |
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20 Monitoring Protein N-Glycosylation Consistency Using HPAEC-Pad |
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365 | (14) |
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21 Oligosaccharide Analysis by High-Performance Anion-Exchange Chromatography Hyphenated to Integrated Pulsed Amperometric Detection and On-Line Ion-Trap Mass Spectrometry |
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379 | (14) |
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PART IV VACCINE APPLICATIONS |
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393 | (56) |
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22 Applications of Ion Chromatography in Biological Product Analyses |
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395 | (28) |
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23 High Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-Pad) Analysis of GBS Glycoconjugate Vaccines: From Fermentation to Final Product |
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423 | (12) |
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24 Stability Studies and Characterization of Meningococcal A, C, Y, and W135 Glycoconjugate Vaccine |
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435 | (14) |
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449 | (2) |
| Appendix 1 Dissociation Constants (pKa) of Organic Acids (at 20°C) |
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451 | (4) |
| Appendix 2 Dissociation Constants (pKa) of Common Sugars and Alcohols |
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455 | (2) |
| Index |
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457 | |
Lokesh Bhattacharyya is a Lab Chief at the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). Prior to beginning his FDA work in 2006, he had over fourteen years of industry experience as an analytical chemist and biochemist. Dr. Bhattacharyya has thirty-nine papers, nine review articles, and nearly thirty conferences as speaker or session chair to his credit.
Jeffrey S. Rohrer is the Director of Applications Development for Thermo Fisher Scientific, Dionex Products. In this position he directs the work of three corporate applications laboratories in California, China, and Thailand. These labs develop HPLC, IC, HPAE-PAD, and other LC-based assays. Dr. Rohrer is an author of over fifty peer-reviewed publications. He is also a member of the United States Pharmacopeia Expert Committee on Monograph Development for Antibiotics, Antivirals, and Antimicrobials.
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