Name: Introduction to Pharmaceutical Analytical Chemistry - Bókakaup
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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
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