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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…mehr
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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.
Produktdetails
- Produktdetails
- Verlag: John Wiley & Sons
- Erscheinungstermin: 7. Februar 2012
- Englisch
- ISBN-13: 9781118146972
- Artikelnr.: 37359856
- Verlag: John Wiley & Sons
- Erscheinungstermin: 7. Februar 2012
- Englisch
- ISBN-13: 9781118146972
- Artikelnr.: 37359856
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.
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.
Contributors ix
Preface xi
Part I Principles, Mechanism, and Instrumentation 1
1 Ion Chromatography—principles and Applications 3
Lokesh Bhattacharyya
2 Retention Processes in Ion-exclusion Chromatography: a New Perspective 23
Milko Novič and Paul R. Haddad
3 Pulsed Electrochemical Detection in Ion Chromatography 49
William R. LaCourse
4 Suppressor Design and Detection for Ion Chromatography 91
Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin, and Christopher Pohl
5 Modelling and Optimization of Ion Chromatographic Separations of Pharmaceutically RelevantOrganic Ions 107
Philip Zakaria, Greg Dicinoski, Melissa Hanna-Brown, and Paul R. Haddad
Part II Pharmaceutical Applications 135
6 Ion Chromatography in Pharmaceutical Drug Analysis 137
Lokesh Bhattacharyya
7 Analysis for Impurities by Ion Chromatography 159
Shreekant V. Karmarkar
8 Ion Chromatography Analysis of Aminoglycoside Antibiotics 175
Valoran P. Hanko and Jeffrey S. Rohrer
9 Use of Cation-exchange Ion Chromatography in the Analysis of Pharmaceuticals 193
Christopher Pohl, Maria Rey, and Rosanne Slingsby
10 Comprehensive Approaches for Measurement of Active Pharmaceutical Ingredients, Counter-ions,and Excipients Using HPLC with Charged Aerosol Detection 221
Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth
11 High Performance Ion Chromatographic Analysis of Cholinergic Compounds: Carbachol andBethanechol, and Associated Degradation Products 237
David Trowbridge
12 Ion Chromatographic Analysis of Pharmaceuticals for Authenticity and Adulteration 247
David S. Jackson
13 Ion Chromatography of Drug Product Counter-ions and other Ions in Drug Products 259
Brian M. De Borba and Jeffrey S. Rohrer
14 Sample Preparation Techniques in Ion Chromatography for Pharmaceutical Applications 271
Jay Gandhi
15 Validation of Ion Chromatographic Methods 285
Shreekant V. Karmarkar
16 Pharmacopeial Applications of Ion Chromatography 309
Ravi Ravichandran
Part III Biotechnology Applications 321
17 Glycan Analysis by High Performance Anion Exchange Chromatography with Pulsed AmperometricDetection 323
Lokesh Bhattacharyya
18 Monosaccharide Analysis of Glycoproteins By High-performance Anion-exchange Chromatographywith Pulsed Amperometric Detection 339
Jeffrey S. Rohrer
19 Two-dimensional Ion Chromatography for Simultaneous Determination of Amino Acids andCarbohydrates 351
Petr Jandik and Jun Cheng
20 Monitoring Protein N-glycosylation Consistency Using Hpaec-pad 365
Carl Grey
21 Oligosaccharide Analysis by High-performance Anion-exchange Chromatography Hyphenated toIntegrated Pulsed Amperometric Detection and On-line Ion-trap Mass Spectrometry 379
Cees Bruggink
Part IV Vaccine Applications 393
22 Applications of Ion Chromatography in Biological Product Analyses 395
Alfred V. Del Grosso and Brandon Duong
23 High Performance Anion-exchange Chromatography With Pulsed Amperometric Detection (hpaec-pad) Analysis of Gbs Glycoconjugate Vaccines: From Fermentation to Final Product 423
Stefano Ricci, Barbara Fabbri, Sara Giannini, Silvia Bernardini, Marcello Morelli, and Sandro D’Ascenzi
24 Stability Studies and Characterization of Meningococcal A, C, Y, and W 135 Glycoconjugate Vaccine435
Valeria Carinci, Alberto Bernardini, Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro D’Ascenzi
Part V Appendices 449
Appendix 1 DISSOCIATION CONSTANTS (pKa) OF ORGANIC Acids (at 20◦C) 451
Appendix 2 DISSOCIATION CONSTANTS (pKa) OF COMMON Sugars and Alcohols 455
Index 457
Preface xi
Part I Principles, Mechanism, and Instrumentation 1
1 Ion Chromatography—principles and Applications 3
Lokesh Bhattacharyya
2 Retention Processes in Ion-exclusion Chromatography: a New Perspective 23
Milko Novič and Paul R. Haddad
3 Pulsed Electrochemical Detection in Ion Chromatography 49
William R. LaCourse
4 Suppressor Design and Detection for Ion Chromatography 91
Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin, and Christopher Pohl
5 Modelling and Optimization of Ion Chromatographic Separations of Pharmaceutically RelevantOrganic Ions 107
Philip Zakaria, Greg Dicinoski, Melissa Hanna-Brown, and Paul R. Haddad
Part II Pharmaceutical Applications 135
6 Ion Chromatography in Pharmaceutical Drug Analysis 137
Lokesh Bhattacharyya
7 Analysis for Impurities by Ion Chromatography 159
Shreekant V. Karmarkar
8 Ion Chromatography Analysis of Aminoglycoside Antibiotics 175
Valoran P. Hanko and Jeffrey S. Rohrer
9 Use of Cation-exchange Ion Chromatography in the Analysis of Pharmaceuticals 193
Christopher Pohl, Maria Rey, and Rosanne Slingsby
10 Comprehensive Approaches for Measurement of Active Pharmaceutical Ingredients, Counter-ions,and Excipients Using HPLC with Charged Aerosol Detection 221
Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth
11 High Performance Ion Chromatographic Analysis of Cholinergic Compounds: Carbachol andBethanechol, and Associated Degradation Products 237
David Trowbridge
12 Ion Chromatographic Analysis of Pharmaceuticals for Authenticity and Adulteration 247
David S. Jackson
13 Ion Chromatography of Drug Product Counter-ions and other Ions in Drug Products 259
Brian M. De Borba and Jeffrey S. Rohrer
14 Sample Preparation Techniques in Ion Chromatography for Pharmaceutical Applications 271
Jay Gandhi
15 Validation of Ion Chromatographic Methods 285
Shreekant V. Karmarkar
16 Pharmacopeial Applications of Ion Chromatography 309
Ravi Ravichandran
Part III Biotechnology Applications 321
17 Glycan Analysis by High Performance Anion Exchange Chromatography with Pulsed AmperometricDetection 323
Lokesh Bhattacharyya
18 Monosaccharide Analysis of Glycoproteins By High-performance Anion-exchange Chromatographywith Pulsed Amperometric Detection 339
Jeffrey S. Rohrer
19 Two-dimensional Ion Chromatography for Simultaneous Determination of Amino Acids andCarbohydrates 351
Petr Jandik and Jun Cheng
20 Monitoring Protein N-glycosylation Consistency Using Hpaec-pad 365
Carl Grey
21 Oligosaccharide Analysis by High-performance Anion-exchange Chromatography Hyphenated toIntegrated Pulsed Amperometric Detection and On-line Ion-trap Mass Spectrometry 379
Cees Bruggink
Part IV Vaccine Applications 393
22 Applications of Ion Chromatography in Biological Product Analyses 395
Alfred V. Del Grosso and Brandon Duong
23 High Performance Anion-exchange Chromatography With Pulsed Amperometric Detection (hpaec-pad) Analysis of Gbs Glycoconjugate Vaccines: From Fermentation to Final Product 423
Stefano Ricci, Barbara Fabbri, Sara Giannini, Silvia Bernardini, Marcello Morelli, and Sandro D’Ascenzi
24 Stability Studies and Characterization of Meningococcal A, C, Y, and W 135 Glycoconjugate Vaccine435
Valeria Carinci, Alberto Bernardini, Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro D’Ascenzi
Part V Appendices 449
Appendix 1 DISSOCIATION CONSTANTS (pKa) OF ORGANIC Acids (at 20◦C) 451
Appendix 2 DISSOCIATION CONSTANTS (pKa) OF COMMON Sugars and Alcohols 455
Index 457
Contributors. Preface. Part I. Principles, Mechanism, and Instrumentation.
1. Ion Chromatography--Principles and Applications (Lokesh Bhattacharyya).
2. Retention Processing in Ion-Exclusion Chromatography: A New Perspective
(Milko Novi and Paul R. Haddad). 3. Pulsed Electrochemical Detection in Ion
Chromatography (William R. LaCourse). 4. Suppressor Design and Detection
for Ion Chromatography (Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin and
Christopher Pohl). 5. Modelling and Optimization of ion Chromatographic
Separations of Pharmaceutically Relevant Organic Ions (Philip Zakaria, Greg
Dicinoski, Melissa Hanna-Brown and Paul R. Haddad). Part II. Pharmaceutical
Applications. 6. Ion Chromatography in Pharmaceutical Drug Analysis (Lokesh
Bhattacharyya). 7. Analysis for Impurities by Ion Chromatography (Shreekant
V. Karmarkar). 8. Ion Chromatography Analysis of Aminoglycoside Antibiotics
(Valoran O. Hanko and Jeffrey S. Rohrer). 9. Use of Cation-Exchange Ion
Chromatography in the Analysis of Pharmaceuticals (Christopher Crafts,
Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth). 10.
Comprehensive Approaches for Measurement of Active Pharmaceutical
Ingredients, Counter-ions, and Excipients using HPLC with Charged Aerosol
Detection (Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu,
and Ian Acworth). 11. High Performance Ion Chromatographic Analysis of
Cholinergic Compounds: Carbachol and Bethanechol, and Associated
Degradation Products (David Trowbridge). 12. Ion Chromatographic Analysis
of Pharmaceuticals for Authenticity and Adulteration (David S. Jackson).
13. Ion Chromatography of Drug Product Counter-ions and other Ions in Drug
Products (Brian M. De Borba and Jeffrey S. Rohrer). 14. Sample Preparation
Techniques in Ion Chromatography for Pharmaceutical Applications (Jay
Gandhi). 15. Validation of Ion Chromatographic Methods (Shreekant V.
Karmarkar). 16. Pharmacopeial Applications of Ion Chromatography (Ravi
Ravichandran). Part III. Biotechnology Applications. 17. Glycan Analysis by
High Performance Anion Exchange Chromatography with Pulsed Amperometric
Detection (Lokesh Bhattacharyya). 18. Monosaccharide Analysis of
Glycoproteins by High-Performance Anion-Exchange (Jeffrey S. Rohrer). 19.
Two-Dimensional Ion Chromatography for Simultaneous Determination of
Carbohydrates and Amino Acids (Petr Jandik and Jun Cheng). 20. Monitoring
Protein N-glycosylation Consistency using HPAEC-PAD (Carl Grey). 21.
Oligosaccharide Analysis by High-Performance Anion-Exchange Chromatography
Hyphenated to Integrated Pulsed Amperometric Detection and On-Line Ion-Trap
Mass Spectrometry (Cees Bruggink). Part IV. Vaccine Applications. 22.
Applications of Ion Chromatography in Biological Analyses (Alfred V. Del
Grosso and Brandon Duong). 23. High Performance Anion-Exchange
Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) Analysis of
GBS Glycoconjugate Vaccines: from Fermentation to Final Product (Stefano
Ricci, Barbara Fabbri, Sara Giannini Silvia Bernardini, and Marcello
Morelli). 24. Stability Studies and Characterization of Meningococcal A, C,
Y, and W135 Glycoconjugate Vaccine (Valeria Carinci, Alberto Bernardini,
Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro
D'Ascenzi). Part V. Appendices. 1. Dissociation Constants (pKa) of Organic
Acids (at 20 oC). 2. Dissociation Constants (pKa) of Common Sugars and
Alcohols. 3. Bibliography on Ion Chromatography and its Application in
Pharmaceuticals and Biotechnology. Index.
1. Ion Chromatography--Principles and Applications (Lokesh Bhattacharyya).
2. Retention Processing in Ion-Exclusion Chromatography: A New Perspective
(Milko Novi and Paul R. Haddad). 3. Pulsed Electrochemical Detection in Ion
Chromatography (William R. LaCourse). 4. Suppressor Design and Detection
for Ion Chromatography (Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin and
Christopher Pohl). 5. Modelling and Optimization of ion Chromatographic
Separations of Pharmaceutically Relevant Organic Ions (Philip Zakaria, Greg
Dicinoski, Melissa Hanna-Brown and Paul R. Haddad). Part II. Pharmaceutical
Applications. 6. Ion Chromatography in Pharmaceutical Drug Analysis (Lokesh
Bhattacharyya). 7. Analysis for Impurities by Ion Chromatography (Shreekant
V. Karmarkar). 8. Ion Chromatography Analysis of Aminoglycoside Antibiotics
(Valoran O. Hanko and Jeffrey S. Rohrer). 9. Use of Cation-Exchange Ion
Chromatography in the Analysis of Pharmaceuticals (Christopher Crafts,
Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth). 10.
Comprehensive Approaches for Measurement of Active Pharmaceutical
Ingredients, Counter-ions, and Excipients using HPLC with Charged Aerosol
Detection (Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu,
and Ian Acworth). 11. High Performance Ion Chromatographic Analysis of
Cholinergic Compounds: Carbachol and Bethanechol, and Associated
Degradation Products (David Trowbridge). 12. Ion Chromatographic Analysis
of Pharmaceuticals for Authenticity and Adulteration (David S. Jackson).
13. Ion Chromatography of Drug Product Counter-ions and other Ions in Drug
Products (Brian M. De Borba and Jeffrey S. Rohrer). 14. Sample Preparation
Techniques in Ion Chromatography for Pharmaceutical Applications (Jay
Gandhi). 15. Validation of Ion Chromatographic Methods (Shreekant V.
Karmarkar). 16. Pharmacopeial Applications of Ion Chromatography (Ravi
Ravichandran). Part III. Biotechnology Applications. 17. Glycan Analysis by
High Performance Anion Exchange Chromatography with Pulsed Amperometric
Detection (Lokesh Bhattacharyya). 18. Monosaccharide Analysis of
Glycoproteins by High-Performance Anion-Exchange (Jeffrey S. Rohrer). 19.
Two-Dimensional Ion Chromatography for Simultaneous Determination of
Carbohydrates and Amino Acids (Petr Jandik and Jun Cheng). 20. Monitoring
Protein N-glycosylation Consistency using HPAEC-PAD (Carl Grey). 21.
Oligosaccharide Analysis by High-Performance Anion-Exchange Chromatography
Hyphenated to Integrated Pulsed Amperometric Detection and On-Line Ion-Trap
Mass Spectrometry (Cees Bruggink). Part IV. Vaccine Applications. 22.
Applications of Ion Chromatography in Biological Analyses (Alfred V. Del
Grosso and Brandon Duong). 23. High Performance Anion-Exchange
Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) Analysis of
GBS Glycoconjugate Vaccines: from Fermentation to Final Product (Stefano
Ricci, Barbara Fabbri, Sara Giannini Silvia Bernardini, and Marcello
Morelli). 24. Stability Studies and Characterization of Meningococcal A, C,
Y, and W135 Glycoconjugate Vaccine (Valeria Carinci, Alberto Bernardini,
Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro
D'Ascenzi). Part V. Appendices. 1. Dissociation Constants (pKa) of Organic
Acids (at 20 oC). 2. Dissociation Constants (pKa) of Common Sugars and
Alcohols. 3. Bibliography on Ion Chromatography and its Application in
Pharmaceuticals and Biotechnology. Index.
Contributors ix
Preface xi
Part I Principles, Mechanism, and Instrumentation 1
1 Ion Chromatography—principles and Applications 3
Lokesh Bhattacharyya
2 Retention Processes in Ion-exclusion Chromatography: a New Perspective 23
Milko Novič and Paul R. Haddad
3 Pulsed Electrochemical Detection in Ion Chromatography 49
William R. LaCourse
4 Suppressor Design and Detection for Ion Chromatography 91
Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin, and Christopher Pohl
5 Modelling and Optimization of Ion Chromatographic Separations of Pharmaceutically RelevantOrganic Ions 107
Philip Zakaria, Greg Dicinoski, Melissa Hanna-Brown, and Paul R. Haddad
Part II Pharmaceutical Applications 135
6 Ion Chromatography in Pharmaceutical Drug Analysis 137
Lokesh Bhattacharyya
7 Analysis for Impurities by Ion Chromatography 159
Shreekant V. Karmarkar
8 Ion Chromatography Analysis of Aminoglycoside Antibiotics 175
Valoran P. Hanko and Jeffrey S. Rohrer
9 Use of Cation-exchange Ion Chromatography in the Analysis of Pharmaceuticals 193
Christopher Pohl, Maria Rey, and Rosanne Slingsby
10 Comprehensive Approaches for Measurement of Active Pharmaceutical Ingredients, Counter-ions,and Excipients Using HPLC with Charged Aerosol Detection 221
Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth
11 High Performance Ion Chromatographic Analysis of Cholinergic Compounds: Carbachol andBethanechol, and Associated Degradation Products 237
David Trowbridge
12 Ion Chromatographic Analysis of Pharmaceuticals for Authenticity and Adulteration 247
David S. Jackson
13 Ion Chromatography of Drug Product Counter-ions and other Ions in Drug Products 259
Brian M. De Borba and Jeffrey S. Rohrer
14 Sample Preparation Techniques in Ion Chromatography for Pharmaceutical Applications 271
Jay Gandhi
15 Validation of Ion Chromatographic Methods 285
Shreekant V. Karmarkar
16 Pharmacopeial Applications of Ion Chromatography 309
Ravi Ravichandran
Part III Biotechnology Applications 321
17 Glycan Analysis by High Performance Anion Exchange Chromatography with Pulsed AmperometricDetection 323
Lokesh Bhattacharyya
18 Monosaccharide Analysis of Glycoproteins By High-performance Anion-exchange Chromatographywith Pulsed Amperometric Detection 339
Jeffrey S. Rohrer
19 Two-dimensional Ion Chromatography for Simultaneous Determination of Amino Acids andCarbohydrates 351
Petr Jandik and Jun Cheng
20 Monitoring Protein N-glycosylation Consistency Using Hpaec-pad 365
Carl Grey
21 Oligosaccharide Analysis by High-performance Anion-exchange Chromatography Hyphenated toIntegrated Pulsed Amperometric Detection and On-line Ion-trap Mass Spectrometry 379
Cees Bruggink
Part IV Vaccine Applications 393
22 Applications of Ion Chromatography in Biological Product Analyses 395
Alfred V. Del Grosso and Brandon Duong
23 High Performance Anion-exchange Chromatography With Pulsed Amperometric Detection (hpaec-pad) Analysis of Gbs Glycoconjugate Vaccines: From Fermentation to Final Product 423
Stefano Ricci, Barbara Fabbri, Sara Giannini, Silvia Bernardini, Marcello Morelli, and Sandro D’Ascenzi
24 Stability Studies and Characterization of Meningococcal A, C, Y, and W 135 Glycoconjugate Vaccine435
Valeria Carinci, Alberto Bernardini, Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro D’Ascenzi
Part V Appendices 449
Appendix 1 DISSOCIATION CONSTANTS (pKa) OF ORGANIC Acids (at 20◦C) 451
Appendix 2 DISSOCIATION CONSTANTS (pKa) OF COMMON Sugars and Alcohols 455
Index 457
Preface xi
Part I Principles, Mechanism, and Instrumentation 1
1 Ion Chromatography—principles and Applications 3
Lokesh Bhattacharyya
2 Retention Processes in Ion-exclusion Chromatography: a New Perspective 23
Milko Novič and Paul R. Haddad
3 Pulsed Electrochemical Detection in Ion Chromatography 49
William R. LaCourse
4 Suppressor Design and Detection for Ion Chromatography 91
Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin, and Christopher Pohl
5 Modelling and Optimization of Ion Chromatographic Separations of Pharmaceutically RelevantOrganic Ions 107
Philip Zakaria, Greg Dicinoski, Melissa Hanna-Brown, and Paul R. Haddad
Part II Pharmaceutical Applications 135
6 Ion Chromatography in Pharmaceutical Drug Analysis 137
Lokesh Bhattacharyya
7 Analysis for Impurities by Ion Chromatography 159
Shreekant V. Karmarkar
8 Ion Chromatography Analysis of Aminoglycoside Antibiotics 175
Valoran P. Hanko and Jeffrey S. Rohrer
9 Use of Cation-exchange Ion Chromatography in the Analysis of Pharmaceuticals 193
Christopher Pohl, Maria Rey, and Rosanne Slingsby
10 Comprehensive Approaches for Measurement of Active Pharmaceutical Ingredients, Counter-ions,and Excipients Using HPLC with Charged Aerosol Detection 221
Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth
11 High Performance Ion Chromatographic Analysis of Cholinergic Compounds: Carbachol andBethanechol, and Associated Degradation Products 237
David Trowbridge
12 Ion Chromatographic Analysis of Pharmaceuticals for Authenticity and Adulteration 247
David S. Jackson
13 Ion Chromatography of Drug Product Counter-ions and other Ions in Drug Products 259
Brian M. De Borba and Jeffrey S. Rohrer
14 Sample Preparation Techniques in Ion Chromatography for Pharmaceutical Applications 271
Jay Gandhi
15 Validation of Ion Chromatographic Methods 285
Shreekant V. Karmarkar
16 Pharmacopeial Applications of Ion Chromatography 309
Ravi Ravichandran
Part III Biotechnology Applications 321
17 Glycan Analysis by High Performance Anion Exchange Chromatography with Pulsed AmperometricDetection 323
Lokesh Bhattacharyya
18 Monosaccharide Analysis of Glycoproteins By High-performance Anion-exchange Chromatographywith Pulsed Amperometric Detection 339
Jeffrey S. Rohrer
19 Two-dimensional Ion Chromatography for Simultaneous Determination of Amino Acids andCarbohydrates 351
Petr Jandik and Jun Cheng
20 Monitoring Protein N-glycosylation Consistency Using Hpaec-pad 365
Carl Grey
21 Oligosaccharide Analysis by High-performance Anion-exchange Chromatography Hyphenated toIntegrated Pulsed Amperometric Detection and On-line Ion-trap Mass Spectrometry 379
Cees Bruggink
Part IV Vaccine Applications 393
22 Applications of Ion Chromatography in Biological Product Analyses 395
Alfred V. Del Grosso and Brandon Duong
23 High Performance Anion-exchange Chromatography With Pulsed Amperometric Detection (hpaec-pad) Analysis of Gbs Glycoconjugate Vaccines: From Fermentation to Final Product 423
Stefano Ricci, Barbara Fabbri, Sara Giannini, Silvia Bernardini, Marcello Morelli, and Sandro D’Ascenzi
24 Stability Studies and Characterization of Meningococcal A, C, Y, and W 135 Glycoconjugate Vaccine435
Valeria Carinci, Alberto Bernardini, Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro D’Ascenzi
Part V Appendices 449
Appendix 1 DISSOCIATION CONSTANTS (pKa) OF ORGANIC Acids (at 20◦C) 451
Appendix 2 DISSOCIATION CONSTANTS (pKa) OF COMMON Sugars and Alcohols 455
Index 457
Contributors. Preface. Part I. Principles, Mechanism, and Instrumentation.
1. Ion Chromatography--Principles and Applications (Lokesh Bhattacharyya).
2. Retention Processing in Ion-Exclusion Chromatography: A New Perspective
(Milko Novi and Paul R. Haddad). 3. Pulsed Electrochemical Detection in Ion
Chromatography (William R. LaCourse). 4. Suppressor Design and Detection
for Ion Chromatography (Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin and
Christopher Pohl). 5. Modelling and Optimization of ion Chromatographic
Separations of Pharmaceutically Relevant Organic Ions (Philip Zakaria, Greg
Dicinoski, Melissa Hanna-Brown and Paul R. Haddad). Part II. Pharmaceutical
Applications. 6. Ion Chromatography in Pharmaceutical Drug Analysis (Lokesh
Bhattacharyya). 7. Analysis for Impurities by Ion Chromatography (Shreekant
V. Karmarkar). 8. Ion Chromatography Analysis of Aminoglycoside Antibiotics
(Valoran O. Hanko and Jeffrey S. Rohrer). 9. Use of Cation-Exchange Ion
Chromatography in the Analysis of Pharmaceuticals (Christopher Crafts,
Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth). 10.
Comprehensive Approaches for Measurement of Active Pharmaceutical
Ingredients, Counter-ions, and Excipients using HPLC with Charged Aerosol
Detection (Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu,
and Ian Acworth). 11. High Performance Ion Chromatographic Analysis of
Cholinergic Compounds: Carbachol and Bethanechol, and Associated
Degradation Products (David Trowbridge). 12. Ion Chromatographic Analysis
of Pharmaceuticals for Authenticity and Adulteration (David S. Jackson).
13. Ion Chromatography of Drug Product Counter-ions and other Ions in Drug
Products (Brian M. De Borba and Jeffrey S. Rohrer). 14. Sample Preparation
Techniques in Ion Chromatography for Pharmaceutical Applications (Jay
Gandhi). 15. Validation of Ion Chromatographic Methods (Shreekant V.
Karmarkar). 16. Pharmacopeial Applications of Ion Chromatography (Ravi
Ravichandran). Part III. Biotechnology Applications. 17. Glycan Analysis by
High Performance Anion Exchange Chromatography with Pulsed Amperometric
Detection (Lokesh Bhattacharyya). 18. Monosaccharide Analysis of
Glycoproteins by High-Performance Anion-Exchange (Jeffrey S. Rohrer). 19.
Two-Dimensional Ion Chromatography for Simultaneous Determination of
Carbohydrates and Amino Acids (Petr Jandik and Jun Cheng). 20. Monitoring
Protein N-glycosylation Consistency using HPAEC-PAD (Carl Grey). 21.
Oligosaccharide Analysis by High-Performance Anion-Exchange Chromatography
Hyphenated to Integrated Pulsed Amperometric Detection and On-Line Ion-Trap
Mass Spectrometry (Cees Bruggink). Part IV. Vaccine Applications. 22.
Applications of Ion Chromatography in Biological Analyses (Alfred V. Del
Grosso and Brandon Duong). 23. High Performance Anion-Exchange
Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) Analysis of
GBS Glycoconjugate Vaccines: from Fermentation to Final Product (Stefano
Ricci, Barbara Fabbri, Sara Giannini Silvia Bernardini, and Marcello
Morelli). 24. Stability Studies and Characterization of Meningococcal A, C,
Y, and W135 Glycoconjugate Vaccine (Valeria Carinci, Alberto Bernardini,
Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro
D'Ascenzi). Part V. Appendices. 1. Dissociation Constants (pKa) of Organic
Acids (at 20 oC). 2. Dissociation Constants (pKa) of Common Sugars and
Alcohols. 3. Bibliography on Ion Chromatography and its Application in
Pharmaceuticals and Biotechnology. Index.
1. Ion Chromatography--Principles and Applications (Lokesh Bhattacharyya).
2. Retention Processing in Ion-Exclusion Chromatography: A New Perspective
(Milko Novi and Paul R. Haddad). 3. Pulsed Electrochemical Detection in Ion
Chromatography (William R. LaCourse). 4. Suppressor Design and Detection
for Ion Chromatography (Kannan Srinivasan, Sheetal Bhardwaj, Rong Lin and
Christopher Pohl). 5. Modelling and Optimization of ion Chromatographic
Separations of Pharmaceutically Relevant Organic Ions (Philip Zakaria, Greg
Dicinoski, Melissa Hanna-Brown and Paul R. Haddad). Part II. Pharmaceutical
Applications. 6. Ion Chromatography in Pharmaceutical Drug Analysis (Lokesh
Bhattacharyya). 7. Analysis for Impurities by Ion Chromatography (Shreekant
V. Karmarkar). 8. Ion Chromatography Analysis of Aminoglycoside Antibiotics
(Valoran O. Hanko and Jeffrey S. Rohrer). 9. Use of Cation-Exchange Ion
Chromatography in the Analysis of Pharmaceuticals (Christopher Crafts,
Bruce Bailey, Paul Gamache, Xiaodong Liu, and Ian Acworth). 10.
Comprehensive Approaches for Measurement of Active Pharmaceutical
Ingredients, Counter-ions, and Excipients using HPLC with Charged Aerosol
Detection (Christopher Crafts, Bruce Bailey, Paul Gamache, Xiaodong Liu,
and Ian Acworth). 11. High Performance Ion Chromatographic Analysis of
Cholinergic Compounds: Carbachol and Bethanechol, and Associated
Degradation Products (David Trowbridge). 12. Ion Chromatographic Analysis
of Pharmaceuticals for Authenticity and Adulteration (David S. Jackson).
13. Ion Chromatography of Drug Product Counter-ions and other Ions in Drug
Products (Brian M. De Borba and Jeffrey S. Rohrer). 14. Sample Preparation
Techniques in Ion Chromatography for Pharmaceutical Applications (Jay
Gandhi). 15. Validation of Ion Chromatographic Methods (Shreekant V.
Karmarkar). 16. Pharmacopeial Applications of Ion Chromatography (Ravi
Ravichandran). Part III. Biotechnology Applications. 17. Glycan Analysis by
High Performance Anion Exchange Chromatography with Pulsed Amperometric
Detection (Lokesh Bhattacharyya). 18. Monosaccharide Analysis of
Glycoproteins by High-Performance Anion-Exchange (Jeffrey S. Rohrer). 19.
Two-Dimensional Ion Chromatography for Simultaneous Determination of
Carbohydrates and Amino Acids (Petr Jandik and Jun Cheng). 20. Monitoring
Protein N-glycosylation Consistency using HPAEC-PAD (Carl Grey). 21.
Oligosaccharide Analysis by High-Performance Anion-Exchange Chromatography
Hyphenated to Integrated Pulsed Amperometric Detection and On-Line Ion-Trap
Mass Spectrometry (Cees Bruggink). Part IV. Vaccine Applications. 22.
Applications of Ion Chromatography in Biological Analyses (Alfred V. Del
Grosso and Brandon Duong). 23. High Performance Anion-Exchange
Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) Analysis of
GBS Glycoconjugate Vaccines: from Fermentation to Final Product (Stefano
Ricci, Barbara Fabbri, Sara Giannini Silvia Bernardini, and Marcello
Morelli). 24. Stability Studies and Characterization of Meningococcal A, C,
Y, and W135 Glycoconjugate Vaccine (Valeria Carinci, Alberto Bernardini,
Cristiana Campa, Claudia Magagnoli, Francesca Beccai, and Sandro
D'Ascenzi). Part V. Appendices. 1. Dissociation Constants (pKa) of Organic
Acids (at 20 oC). 2. Dissociation Constants (pKa) of Common Sugars and
Alcohols. 3. Bibliography on Ion Chromatography and its Application in
Pharmaceuticals and Biotechnology. Index.