Efnisyfirlit

• Preface to the Second Edition
• Abbreviations
• Symbols and Units
  • Constants
  • Greek alphabet
• 1 Introduction to Pharmaceutical Analytical Chemistry
  • 1.1 Introduction
  • 1.2 Pharmaceutical Analytical Chemistry
  • 1.3 This Textbook
• 2 Marketing Authorizations, Pharmaceutical Manufacturing, and International Pharmacopoeias
  • 2.1 Introduction
  • 2.2 Marketing Authorization and Industrial Production
  • 2.3 Pharmacopoeias
  • 2.4 Life Time of Pharmaceutical Preparations and Ingredients
• 3 Fundamentals of Bases, Acids, Solubility, Polarity, Partition, and Stereochemistry
  • 3.1 Acids, Bases, pH, and pK a
  • 3.2 Buffers
  • 3.3 Acid and Base Properties of Drug Substances
  • 3.4 Distribution Between Phases
  • 3.5 Stereoisomers
  • 3.6 Active Pharmaceutical Ingredients – A Few Examples
  • 3.7 Stability of Drug Substances
• 4 Fundamentals of Pharmaceutical Analytical Chemistry
  • 4.1 Pharmaceutical Analytical Chemistry
  • 4.2 How to Specify Quantities, Concentrations, and Compositions of Mixtures
  • 4.3 Laboratory Equipment
  • 4.4 How to Make Solutions and Dilutions
  • 4.5 Errors, Accuracy, and Precision
  • 4.6 Statistical Tests
  • 4.7 Linear Regression Analysis
  • 4.8 How to Present an Analytical Result
  • 4.9 Additional Words and Terms
• 5 Titration
  • 5.1 Introduction
  • 5.2 Potentiometric Titration and Electrodes
  • 5.3 Aqueous Acid–Base Titrations
  • 5.4 Titration in Non‐aqueous Solvents
  • 5.5 Redox Titrations
  • 5.6 Alternative Principles of Titration
• 6 Introduction to Spectroscopic Methods
  • 6.1 Electromagnetic Radiation
  • 6.2 Molecules and Absorption of Electromagnetic Radiation
  • 6.3 Absorbing Structures – Chromophores
  • 6.4 Fluorescence
  • 6.5 Atoms and Electromagnetic Radiation
• 7 UV‐Vis Spectrophotometry
  • 7.1 Areas of Use
  • 7.2 Quantitation
  • 7.3 Absorbance Dependence on Measurement Conditions
  • 7.4 Identification
  • 7.5 Instrumentation
  • 7.6 Practical Work and Method Development
  • 7.7 Test of Spectrophotometers
  • 7.8 Fluorimetry
• 8 IR Spectrophotometry
  • 8.1 IR Spectrophotometry
  • 8.2 Instrumentation
  • 8.3 Recording by Transmission, Diffuse Reflectance, and Attenuated Total Reflection
  • 8.4 Instrument Calibration
  • 8.5 NIR Spectrophotometry
• 9 Atomic Spectrometry
  • 9.1 Applications of Atomic Spectrometry
  • 9.2 Atomic Absorption Spectrometry (AAS)
  • 9.3 AAS Instrumentation
  • 9.4 AAS Practical Work and Method Development
  • 9.5 Atomic Emission Spectrometry (AES)
  • 9.6 Flame Photometry
  • 9.7 Inductively Coupled Plasma Emission Spectrometry
  • 9.8 Inductively Coupled Plasma Mass Spectrometry
• 10 Introduction to Chromatography
  • 10.1 Introduction
  • 10.2 General Principles
  • 10.3 Retention
  • 10.4 Efficiency
  • 10.5 Selectivity
  • 10.6 Resolution
  • 10.7 Peak Symmetry
  • 10.8 The Dynamics of Chromatography
• 11 Separation Principles in Liquid Chromatography
  • 11.1 Introduction
  • 11.2 Reversed‐Phase Chromatography
  • 11.3 Ion‐Pair Chromatography
  • 11.4 Normal‐Phase Chromatography
  • 11.5 Thin‐Layer Chromatography
  • 11.6 Hydrophilic Interaction Chromatography
  • 11.7 Ion Exchange Chromatography
  • 11.8 Size Exclusion Chromatography
  • 11.9 Chiral Separations
  • 11.10 Supercritical Fluid Chromatography
• 12 High Performance Liquid Chromatography
  • 12.1 Introduction
  • 12.2 The Column
  • 12.3 Scaling Between Columns
  • 12.4 Pumps
  • 12.5 Injectors
  • 12.6 Detectors
  • 12.7 Mobile Phases
  • 12.8 Solvents for Sample Preparation
• 13 Gas Chromatography
  • 13.1 Introduction
  • 13.2 Basic Principle
  • 13.3 Instrumentation
  • 13.4 Carrier Gas
  • 13.5 Stationary Phases
  • 13.6 Retention
  • 13.7 Columns
  • 13.8 Injection
  • 13.9 Detectors
  • 13.10 Derivatization
• 14 Electrophoretic Methods
  • 14.1 Introduction
  • 14.2 Principle and Theory
  • 14.3 Gel Electrophoresis
  • 14.4 SDS‐PAGE
  • 14.5 Western Blotting
  • 14.6 Isoelectric Focusing
  • 14.7 Capillary Electrophoresis
• 15 Mass Spectrometry
  • 15.1 Introduction
  • 15.2 Basic Theory of Mass Spectrometry
  • 15.3 Ionization
  • 15.4 The Mass Spectrometer as a Chromatographic Detector – Data Acquisition
  • 15.5 Quantitation by MS
  • 15.6 Identification by MS
  • 15.7 Instrumentation
• 16 Sample Preparation
  • 16.1 When is Sample Preparation Required?
  • 16.2 Main Strategies
  • 16.3 Recovery and Enrichment
  • 16.4 Liquid–Liquid Extraction
  • 16.5 Solid–Liquid Extraction
  • 16.6 Solid Phase Extraction
• 17 Quality of Analytical Data and Validation
  • 17.1 Instrumental Signals
  • 17.2 Calibration Methods
  • 17.3 Analytical Procedures
  • 17.4 Validation
  • 17.5 System Suitability
• 18 Chemical Analysis of Pharmaceutical Ingredients
  • 18.1 Pharmaceutical Ingredients, Production, and Control
  • 18.2 Pharmacopoeia Monographs
  • 18.3 Impurities in Pharmaceutical Ingredients
  • 18.4 Identification of Pharmaceutical Ingredients
  • 18.5 Impurity Testing of Pharmaceutical Ingredients (Pure Chemical Ingredients)
  • 18.6 Identification and Impurity Testing of Organic Multi‐Chemical Ingredients
  • 18.7 Assay of Pharmaceutical Ingredients
  • 18.8 Chemical Analysis of Pharmaceutical Ingredients Not Included in Pharmacopoeias
• 19 Chemical Analysis of Pharmaceutical Preparations
  • 19.1 Chemical Analysis of Pharmaceutical Preparations
  • 19.2 Monographs and Chemical Analysis
  • 19.3 Identification of the API
  • 19.4 Assay of the Active Pharmaceutical Ingredient
  • 19.5 Chemical Tests for Pharmaceutical Preparations
• 20 Bioanalysis Chemical Analysis of Pharmaceuticals in Biological Fluids
  • 20.1 Bioanalysis
  • 20.2 Biological Fluids
  • 20.3 Bioanalytical Methods – An Overview
  • 20.4 Sampling
  • 20.5 Sample Preparation
  • 20.6 Separation and Detection
  • 20.7 Quantitation
  • 20.8 Screening
• 21 Chemical Analysis of Biopharmaceuticals
  • 21.1 Biopharmaceuticals
  • 21.2 Biopharmaceuticals versus Small Molecule APIs
  • 21.3 Biopharmaceuticals and Pharmacopoeias
  • 21.4 Production of Biopharmaceuticals
  • 21.5 Identification Procedures for Biopharmaceuticals (Active Substance)
  • 21.6 Impurity Tests for Biopharmaceuticals (Active Substances)
  • 21.7 Assay of Biopharmaceuticals (Active Substance)
  • 21.8 Monoclonal Antibodies
  • 21.9 Analysis of Biopharmaceutical Products
  • 21.10 Bioanalysis of Biopharmaceuticals Using LC‐MS/MS
• Index
• End User License Agreement

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