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