Introduction to Pharmaceutical Analytical Chemistry 2e

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Language: Anglais
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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

Abbreviations

Symbols and Units

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 pKa

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

STIG PEDERSEN-BJERGAARD is Professor at the Department of Pharmacy, University of Oslo and Professor at the Department of Pharmacy, University of Copenhagen.

BENTE GAMMELGAARD is Professor at the Department of Pharmacy, University of Copenhagen.

TRINE GRØNHAUG HALVORSEN is Associate Professor at the Department of Pharmacy, University of Oslo.