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Introduction to Pharmaceutical Analytical Chemistry, 2nd Edition

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$70.00

Introduction to Pharmaceutical Analytical Chemistry, 2nd Edition

Stig Pedersen-Bjergaard, Bente Gammelgaard, Trine G. Halvorsen

ISBN: 978-1-119-36272-2 April 2019 544 Pages

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Description

The definitive textbook on the chemical analysis of pharmaceutical drugs ­– fully revised and updated 

Introduction to Pharmaceutical Analytical Chemistry enables students to gain fundamental knowledge of the vital concepts, techniques and applications of the chemical analysis of pharmaceutical ingredients, final pharmaceutical products and drug substances in biological fluids. A unique emphasis on pharmaceutical laboratory practices, such as sample preparation and separation techniques, provides an efficient and practical educational framework for undergraduate studies in areas such as pharmaceutical sciences, analytical chemistry and forensic analysis. Suitable for foundational courses, this essential undergraduate text introduces the common analytical methods used in quantitative and qualitative chemical analysis of pharmaceuticals.

This extensively revised second edition includes a new chapter on chemical analysis of biopharmaceuticals, which includes discussions on identification, purity testing and assay of peptide and protein-based formulations. Also new to this edition are improved colour illustrations and tables, a streamlined chapter structure and text revised for increased clarity and comprehension.

  • Introduces the fundamental concepts of pharmaceutical analytical chemistry and statistics
  • Presents a systematic investigation of pharmaceutical applications absent from other textbooks on the subject
  • Examines various analytical techniques commonly used in pharmaceutical laboratories
  • Provides practice problems, up-to-date practical examples and detailed illustrations
  • Includes updated content aligned with the current European and United States Pharmacopeia regulations and guidelines 

Covering the analytical techniques and concepts necessary for pharmaceutical analytical chemistry, Introduction to Pharmaceutical Analytical Chemistry is ideally suited for students of chemical and pharmaceutical sciences as well as analytical chemists transitioning into the field of pharmaceutical analytical chemistry.

Preface to the Second Edition xv

Abbreviations xvii

Symbols and Units xxi

1 Introduction to Pharmaceutical Analytical Chemistry 1

1.1 Introduction 1

1.2 Pharmaceutical Analytical Chemistry 4

1.3 This Textbook 7

2 Marketing Authorizations, Pharmaceutical Manufacturing, and International Pharmacopoeias 9

2.1 Introduction 9

2.2 Marketing Authorization and Industrial Production 10

2.3 Pharmacopoeias 13

2.4 Life Time of Pharmaceutical Preparations and Ingredients 14

3 Fundamentals of Bases, Acids, Solubility, Polarity, Partition, and Stereochemistry 17

3.1 Acids, Bases, pH, and pKa 17

3.2 Buffers 19

3.3 Acid and Base Properties of Drug Substances 20

3.4 Distribution Between Phases 21

3.5 Stereoisomers 26

3.6 Active Pharmaceutical Ingredients – A Few Examples 28

3.7 Stability of Drug Substances 34

4 Fundamentals of Pharmaceutical Analytical Chemistry 37

4.1 Pharmaceutical Analytical Chemistry 37

4.2 How to Specify Quantities, Concentrations, and Compositions of Mixtures 39

4.3 Laboratory Equipment 43

4.4 How to Make Solutions and Dilutions 52

4.5 Errors, Accuracy, and Precision 54

4.6 Statistical Tests 56

4.7 Linear Regression Analysis 65

4.8 How to Present an Analytical Result 68

4.9 Additional Words and Terms 70

5 Titration 73

5.1 Introduction 73

5.2 Potentiometric Titration and Electrodes 79

5.3 Aqueous Acid–Base Titrations 82

5.4 Titration in Non-aqueous Solvents 88

5.5 Redox Titrations 91

5.6 Alternative Principles of Titration 95

6 Introduction to Spectroscopic Methods 97

6.1 Electromagnetic Radiation 97

6.2 Molecules and Absorption of Electromagnetic Radiation 99

6.3 Absorbing Structures – Chromophores 101

6.4 Fluorescence 101

6.5 Atoms and Electromagnetic Radiation 102

7 UV-Vis Spectrophotometry 105

7.1 Areas of Use 105

7.2 Quantitation 106

7.3 Absorbance Dependence on Measurement Conditions 108

7.4 Identification 110

7.5 Instrumentation 111

7.6 Practical Work and Method Development 115

7.7 Test of Spectrophotometers 116

7.8 Fluorimetry 119

8 IR Spectrophotometry 121

8.1 IR Spectrophotometry 121

8.2 Instrumentation 125

8.3 Recording by Transmission, Diffuse Reflectance, and Attenuated Total Reflection 125

8.4 Instrument Calibration 128

8.5 NIR Spectrophotometry 129

9 Atomic Spectrometry 131

9.1 Applications of Atomic Spectrometry 131

9.2 Atomic Absorption Spectrometry (AAS) 132

9.3 AAS Instrumentation 132

9.4 AAS Practical Work and Method Development 137

9.5 Atomic Emission Spectrometry (AES) 138

9.6 Flame Photometry 139

9.7 Inductively Coupled Plasma Emission Spectrometry 140

9.8 Inductively Coupled Plasma Mass Spectrometry 141

10 Introduction to Chromatography 143

10.1 Introduction 143

10.2 General Principles 144

10.3 Retention 146

10.4 Efficiency 149

10.5 Selectivity 151

10.6 Resolution 152

10.7 Peak Symmetry 154

10.8 The Dynamics of Chromatography 155

11 Separation Principles in Liquid Chromatography 159

11.1 Introduction 159

11.2 Reversed-Phase Chromatography 160

11.3 Ion-Pair Chromatography 168

11.4 Normal-Phase Chromatography 170

11.5 Thin-Layer Chromatography 173

11.6 Hydrophilic Interaction Chromatography 175

11.7 Ion Exchange Chromatography 177

11.8 Size Exclusion Chromatography 178

11.9 Chiral Separations 180

11.10 Supercritical Fluid Chromatography 182

12 High Performance Liquid Chromatography 185

12.1 Introduction 185

12.2 The Column 186

12.3 Scaling Between Columns 188

12.4 Pumps 189

12.5 Injectors 191

12.6 Detectors 192

12.7 Mobile Phases 197

12.8 Solvents for Sample Preparation 198

13 Gas Chromatography 199

13.1 Introduction 199

13.2 Basic Principle 200

13.3 Instrumentation 201

13.4 Carrier Gas 203

13.5 Stationary Phases 205

13.6 Retention 207

13.7 Columns 208

13.8 Injection 209

13.9 Detectors 211

13.10 Derivatization 213

14 Electrophoretic Methods 215

14.1 Introduction 215

14.2 Principle and Theory 216

14.3 Gel Electrophoresis 218

14.4 SDS-PAGE 220

14.5 Western Blotting 221

14.6 Isoelectric Focusing 223

14.7 Capillary Electrophoresis 223

15 Mass Spectrometry 231

15.1 Introduction 231

15.2 Basic Theory of Mass Spectrometry 233

15.3 Ionization 235

15.4 The Mass Spectrometer as a Chromatographic Detector – Data Acquisition 236

15.5 Quantitation by MS 238

15.6 Identification by MS 238

15.7 Instrumentation 251

16 Sample Preparation 259

16.1 When is Sample Preparation Required? 259

16.2 Main Strategies 260

16.3 Recovery and Enrichment 261

16.4 Liquid–Liquid Extraction 263

16.5 Solid–Liquid Extraction 269

16.6 Solid Phase Extraction 270

17 Quality of Analytical Data and Validation 281

17.1 Instrumental Signals 281

17.2 Calibration Methods 282

17.3 Analytical Procedures 290

17.4 Validation 291

17.5 System Suitability 301

18 Chemical Analysis of Pharmaceutical Ingredients 305

18.1 Pharmaceutical Ingredients, Production, and Control 306

18.2 Pharmacopoeia Monographs 308

18.3 Impurities in Pharmaceutical Ingredients 321

18.4 Identification of Pharmaceutical Ingredients 324

18.5 Impurity Testing of Pharmaceutical Ingredients (Pure Chemical Ingredients) 344

18.6 Identification and Impurity Testing of Organic Multi-Chemical Ingredients 368

18.7 Assay of Pharmaceutical Ingredients 375

18.8 Chemical Analysis of Pharmaceutical Ingredients Not Included in Pharmacopoeias 388

19 Chemical Analysis of Pharmaceutical Preparations 389

19.1 Chemical Analysis of Pharmaceutical Preparations 389

19.2 Monographs and Chemical Analysis 390

19.3 Identification of the API 395

19.4 Assay of the Active Pharmaceutical Ingredient 410

19.5 Chemical Tests for Pharmaceutical Preparations 427

20 Bioanalysis Chemical Analysis of Pharmaceuticals in Biological Fluids 433

20.1 Bioanalysis 433

20.2 Biological Fluids 438

20.3 Bioanalytical Methods – An Overview 440

20.4 Sampling 440

20.5 Sample Preparation 441

20.6 Separation and Detection 446

20.7 Quantitation 447

20.8 Screening 453

21 Chemical Analysis of Biopharmaceuticals 459

21.1 Biopharmaceuticals 459

21.2 Biopharmaceuticals versus Small Molecule APIs 463

21.3 Biopharmaceuticals and Pharmacopoeias 464

21.4 Production of Biopharmaceuticals 465

21.5 Identification Procedures for Biopharmaceuticals (Active Substance) 467

21.6 Impurity Tests for Biopharmaceuticals (Active Substances) 488

21.7 Assay of Biopharmaceuticals (Active Substance) 498

21.8 Monoclonal Antibodies 500

21.9 Analysis of Biopharmaceutical Products 502

21.10 Bioanalysis of Biopharmaceuticals Using LC-MS/MS 503

Index 505