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E-grāmata: Introduction to Pharmaceutical Analytical Chemistry

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(University of Copenhagen), (University of Copenhagen), (University of Oslo)
  • Formāts: PDF+DRM
  • Izdošanas datums: 06-Feb-2019
  • Izdevniecība: John Wiley & Sons Inc
  • Valoda: eng
  • ISBN-13: 9781119362739
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Introduction to Pharmaceutical Analytical ChemistryPalielināt
  • Formāts: PDF+DRM
  • Izdošanas datums: 06-Feb-2019
  • Izdevniecība: John Wiley & Sons Inc
  • Valoda: eng
  • ISBN-13: 9781119362739
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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 xv
Abbreviations xvii
Symbols and Units xxi
1 Introduction to Pharmaceutical Analytical Chemistry 1(8)
1.1 Introduction
1.2 Pharmaceutical Analytical Chemistry
4(3)
1.2.1 A Brief Definition
4(1)
1.2.2 Manufacture of Pharmaceuticals
4(2)
1.2.3 Development of New Drugs
6(1)
1.2.4 Use of Pharmaceuticals
6(1)
1.3 This Textbook
7(2)
2 Marketing Authorizations, Pharmaceutical Manufacturing, and International Pharmacopoeias 9(8)
2.1 Introduction
9(1)
2.2 Marketing Authorization and Industrial Production
10(3)
2.3 Pharmacopoeias
13(1)
2.4 Life Time of Pharmaceutical Preparations and Ingredients
14(3)
3 Fundamentals of Bases, Acids, Solubility, Polarity, Partition, and Stereochemistry 17(20)
3.1 Acids, Bases, pH, and pKa
17(2)
3.2 Buffers
19(1)
3.3 Acid and Base Properties of Drug Substances
20(1)
3.4 Distribution Between Phases
21(5)
3.5 Stereoisomers
26(2)
3.6 Active Pharmaceutical Ingredients - A Few Examples
28(6)
3.6.1 Fluoxetine - A Basic and Lipophilic Drug
28(1)
3.6.2 Atenolol - A More Polar Basic Drug
29(1)
3.6.3 Morphine - A Zwitterionic Drug (Base and Acid)
30(1)
3.6.4 Ibuprofen - An Acidic Drug
31(2)
3.6.5 Paracetamol - A Weak Acid
33(1)
3.6.6 Hydrocortisone - A Neutral Drug
34(1)
3.7 Stability of Drug Substances
34(3)
4 Fundamentals of Pharmaceutical Analytical Chemistry 37(36)
4.1 Pharmaceutical Analytical Chemistry
37(2)
4.2 How to Specify Quantities, Concentrations, and Compositions of Mixtures
39(4)
4.3 Laboratory Equipment
43(9)
4.3.1 The Analytical Balance
43(4)
4.3.2 Pipettes
47(3)
4.3.3 Volumetric Flasks
50(1)
4.3.4 Burettes
51(1)
4.4 How to Make Solutions and Dilutions
52(2)
4.5 Errors, Accuracy, and Precision
54(2)
4.5.1 Systematic and Random Errors
54(1)
4.5.2 Accuracy and Precision
55(1)
4.6 Statistical Tests
56(9)
4.6.1 Mean Value and Standard Deviation
56(2)
4.6.2 Confidence Intervals
58(1)
4.6.3 Comparison of Standard Deviations with the F-Test
58(2)
4.6.4 Comparison of Means with a t-Test
60(4)
4.6.5 Q-Test to Reject Outliers
64(1)
4.7 Linear Regression Analysis
65(3)
4.8 How to Present an Analytical Result
68(2)
4.9 Additional Words and Terms
70(3)
5 Titration 73(24)
5.1 Introduction
73(6)
5.2 Potentiometric Titration and Electrodes
79(3)
5.3 Aqueous Acid-Base Titrations
82(6)
5.4 Titration in Non-aqueous Solvents
88(3)
5.5 Redox Titrations
91(4)
5.6 Alternative Principles of Titration
95(2)
6 Introduction to Spectroscopic Methods 97(8)
6.1 Electromagnetic Radiation
97(2)
6.2 Molecules and Absorption of Electromagnetic Radiation
99(2)
6.3 Absorbing Structures - Chromophores
101(1)
6.4 Fluorescence
101(1)
6.5 Atoms and Electromagnetic Radiation
102(3)
7 UV-Vis Spectrophotometry 105(16)
7.1 Areas of Use
105(1)
7.2 Quantitation
106(2)
7.3 Absorbance Dependence on Measurement Conditions
108(2)
7.4 Identification
110(1)
7.5 Instrumentation
111(4)
7.5.1 Radiation Sources
112(1)
7.5.2 Monochromator
112(1)
7.5.3 Sample Containers
113(1)
7.5.4 Detectors
114(1)
7.5.5 Single-Beam and Double-Beam Instruments
114(1)
7.6 Practical Work and Method Development
115(1)
7.7 Test of Spectrophotometers
116(3)
7.7.1 Control of Wavelengths
117(1)
7.7.2 Control of Absorbance
117(1)
7.7.3 Limit of Stray Light
118(1)
7.7.4 Resolution (for Qualitative Analysis)
119(1)
7.7.5 Spectral Slit-Width (for Quantitative Analysis)
119(1)
7.8 Fluorimetry
119(2)
8 IR Spectrophotometry 121(10)
8.1 IR Spectrophotometry
121(4)
8.2 Instrumentation
125(1)
8.3 Recording by Transmission, Diffuse Reflectance, and Attenuated Total Reflection
125(3)
8.4 Instrument Calibration
128(1)
8.5 NIR Spectrophotometry
129(2)
9 Atomic Spectrometry 131(12)
9.1 Applications of Atomic Spectrometry
131(1)
9.2 Atomic Absorption Spectrometry (AAS)
132(1)
9.3 AAS Instrumentation
132(5)
9.3.1 Radiation Sources
133(1)
9.3.2 Sample Introduction System
133(1)
9.3.3 Sample Atomizer
134(1)
9.3.4 Monochromator
135(1)
9.3.5 Electrothermal Atomizer
135(1)
9.3.6 Interferences
136(1)
9.3.7 Background Correction
137(1)
9.4 AAS Practical Work and Method Development
137(1)
9.5 Atomic Emission Spectrometry (AES)
138(1)
9.6 Flame Photometry
139(1)
9.7 Inductively Coupled Plasma Emission Spectrometry
140(1)
9.8 Inductively Coupled Plasma Mass Spectrometry
141(2)
10 Introduction to Chromatography 143(16)
10.1 Introduction
143(1)
10.2 General Principles
144(2)
10.3 Retention
146(3)
10.4 Efficiency
149(2)
10.5 Selectivity
151(1)
10.6 Resolution
152(2)
10.7 Peak Symmetry
154(1)
10.8 The Dynamics of Chromatography
155(4)
11 Separation Principles in Liquid Chromatography 159(26)
11.1 Introduction
159(1)
11.2 Reversed-Phase Chromatography
160(8)
11.2.1 Stationary Phases
160(2)
11.2.2 Retention Mechanisms
162(2)
11.2.3 Mobile Phases
164(4)
11.3 Ion-Pair Chromatography
168(2)
11.4 Normal-Phase Chromatography
170(3)
11.4.1 Silica and Related Stationary Phases
171(1)
11.4.2 Molecular Interactions and Retention
172(1)
11.4.3 Mobile Phases
173(1)
11.5 Thin-Layer Chromatography
173(2)
11.6 Hydrophilic Interaction Chromatography
175(2)
11.7 Ion Exchange Chromatography
177(1)
11.8 Size Exclusion Chromatography
178(2)
11.9 Chiral Separations
180(2)
11.10 Supercritical Fluid Chromatography
182(3)
12 High Performance Liquid Chromatography 185(14)
12.1 Introduction
185(1)
12.2 The Column
186(2)
12.3 Scaling Between Columns
188(1)
12.4 Pumps
189(2)
12.5 Injectors
191(1)
12.6 Detectors
192(5)
12.6.1 UV Detectors
193(2)
12.6.2 Fluorescence Detectors
195(1)
12.6.3 Electrochemical Detectors
196(1)
12.6.4 Refractive Index, Evaporative Light Scattering, and Charged Aerosol Detectors
197(1)
12.7 Mobile Phases
197(1)
12.8 Solvents for Sample Preparation
198(1)
13 Gas Chromatography 199(16)
13.1 Introduction
199(1)
13.2 Basic Principle
200(1)
13.3 Instrumentation
201(2)
13.4 Carrier Gas
203(2)
13.5 Stationary Phases
205(2)
13.6 Retention
207(1)
13.7 Columns
208(1)
13.8 Injection
209(2)
13.9 Detectors
211(2)
13.10 Derivatization
213(2)
14 Electrophoretic Methods 215(16)
14.1 Introduction
215(1)
14.2 Principle and Theory
216(2)
14.3 Gel Electrophoresis
218(2)
14.4 SDS-PAGE
220(1)
14.5 Western Blotting
221(2)
14.6 Isoelectric Focusing
223(1)
14.7 Capillary Electrophoresis
223(8)
14.7.1 Principle and Instrumentation
223(1)
14.7.2 Electro-osmotic Flow and Mobility
224(2)
14.7.3 Dispersion
226(2)
14.7.4 Capillaries
228(1)
14.7.5 Sample Introduction
228(1)
14.7.6 Detection
229(1)
14.7.7 Applications
229(2)
15 Mass Spectrometry 231(28)
15.1 Introduction
231(2)
15.2 Basic Theory of Mass Spectrometry
233(2)
15.3 Ionization
235(1)
15.4 The Mass Spectrometer as a Chromatographic Detector - Data Acquisition
236(2)
15.5 Quantitation by MS
238(1)
15.6 Identification by MS
238(13)
15.6.1 GC-MS and LC-MS
238(2)
15.6.2 Structural Information from Isotopes
240(2)
15.6.3 Structural Information from Fragmentation
242(5)
15.6.4 Structural Information from Accurate Masses (High Resolution MS)
247(2)
15.6.5 Structural Information for Peptides and Proteins
249(2)
15.7 Instrumentation
251(8)
15.7.1 Ion Sources for GC-MS
251(1)
15.7.2 Ion Sources for LC-MS
252(2)
15.7.3 Single Quadrupole Analysers
254(1)
15.7.4 Triple Quadrupole Analysers
255(1)
15.7.5 Ion Trap Analysers
256(1)
15.7.6 Time-of-Flight Analysers
257(1)
15.7.7 High Resolution Instruments
258(1)
15.7.8 Matrix-Assisted Laser Desorption/Ionization Mass Spectrometry
258(1)
16 Sample Preparation 259(22)
16.1 When is Sample Preparation Required?
259(1)
16.2 Main Strategies
260(1)
16.3 Recovery and Enrichment
261(2)
16.4 Liquid-Liquid Extraction
263(6)
16.4.1 Procedure
263(1)
16.4.2 Theory
264(1)
16.4.3 Extraction Solvents
265(2)
16.4.4 Parameters Affecting Extraction Recovery
267(2)
16.4.5 Liquid-Liquid Extraction with Back-Extraction
269(1)
16.5 Solid-Liquid Extraction
269(1)
16.6 Solid Phase Extraction
270(11)
16.6.1 Fundamentals
270(1)
16.6.2 The Solid Phase Extraction Column
271(1)
16.6.3 Conditioning
272(1)
16.6.4 Equipment
272(1)
16.6.5 Reversed-Phase Solid Phase Extraction
273(2)
16.6.6 Secondary Interactions
275(1)
16.6.7 Ion Exchange Solid Phase Extraction
275(3)
16.6.8 Mixed-Mode Solid Phase Extraction
278(1)
16.6.9 Normal-Phase Solid Phase Extraction
279(2)
17 Quality of Analytical Data and Validation 281(24)
17.1 Instrumental Signals
281(1)
17.2 Calibration Methods
282(8)
17.2.1 External Standard
283(1)
17.2.2 One Point Calibration
284(1)
17.2.3 Internal Standard
285(3)
17.2.4 Standard Addition
288(1)
17.2.5 Normalization
289(1)
17.3 Analytical Procedures
290(1)
17.4 Validation
291(10)
17.4.1 Specificity
292(1)
17.4.2 Accuracy
293(1)
17.4.3 Precision
294(1)
17.4.4 Detection Limit
295(2)
17.4.5 Quantitation Limit
297(1)
17.4.6 Linearity and Range
298(2)
17.4.7 Robustness
300(1)
17.4.8 Test Methods in Ph. Eur. and USP
300(1)
17.5 System Suitability
301(4)
17.5.1 Adjustment of Chromatographic Conditions
301(4)
18 Chemical Analysis of Pharmaceutical Ingredients 305(84)
18.1 Pharmaceutical Ingredients, Production, and Control
306(2)
18.2 Pharmacopoeia Monographs
308(13)
18.3 Impurities in Pharmaceutical Ingredients
321(3)
18.3.1 Impurities in Pure Chemical Ingredients
321(3)
18.3.2 Impurities in Organic Multi-Chemical Ingredients
324(1)
18.4 Identification of Pharmaceutical Ingredients
324(20)
18.4.1 IR Spectrophotometry
324(6)
18.4.2 UV-Vis Spectrophotometry
330(3)
18.4.3 Thin-Layer Chromatography
333(1)
18.4.4 Melting Point
334(1)
18.4.5 Optical Rotation
335(5)
18.4.6 Liquid Chromatography
340(1)
18.4.7 Chloride and Sulfate Identification
341(3)
18.5 Impurity Testing of Pharmaceutical Ingredients (Pure Chemical Ingredients)
344(24)
18.5.1 Appearance of Solution
345(2)
18.5.2 Absorbance
347(1)
18.5.3 pH and Acidity or Alkalinity
347(4)
18.5.4 Related Substances
351(4)
18.5.5 Residual Solvents
355(4)
18.5.6 Foreign Anions
359(2)
18.5.7 Sulfated Ash
361(2)
18.5.8 Elemental Impurities
363(3)
18.5.9 Loss on Drying
366(1)
18.5.10 Water
367(1)
18.6 Identification and Impurity Testing of Organic Multi-Chemical Ingredients
368(7)
18.6.1 Oxidizing Substances
369(1)
18.6.2 Acid Value
369(1)
18.6.3 Hydroxyl Value
369(1)
18.6.4 Iodine Value
370(1)
18.6.5 Peroxide Value
371(1)
18.6.6 Saponification Value
371(1)
18.6.7 Unsaponifiable Matter
372(1)
18.6.8 Other Tests
372(3)
18.7 Assay of Pharmaceutical Ingredients
375(13)
18.7.1 Aqueous Acid-Base Titration
375(5)
18.7.2 Non-Aqueous Acid-Base Titration
380(3)
18.7.3 Redox Titrations
383(2)
18.7.4 Liquid Chromatography
385(2)
18.7.5 UV-Vis Spectrophotometry
387(1)
18.8 Chemical Analysis of Pharmaceutical Ingredients Not Included in Pharmacopoeias
388(1)
19 Chemical Analysis of Pharmaceutical Preparations 389(44)
19.1 Chemical Analysis of Pharmaceutical Preparations
389(1)
19.2 Monographs and Chemical Analysis
390(5)
19.3 Identification of the API
395(15)
19.3.1 Identification by IR Spectrophotometry
396(5)
19.3.2 Identification by Liquid Chromatography
401(5)
19.3.3 Identification by UV-Vis Spectrophotometry
406(4)
19.4 Assay of the Active Pharmaceutical Ingredient
410(17)
19.4.1 Assays Based on Liquid Chromatography
411(8)
19.4.2 Assays Based on UV Spectrophotometry
419(4)
19.4.3 Assays Based on Titration
423(4)
19.5 Chemical Tests for Pharmaceutical Preparations
427(6)
19.5.1 Test for Related Substances
427(3)
19.5.2 Uniformity of Content
430(2)
19.5.3 Dissolution
432(1)
20 Bioanalysis Chemical Analysis of Pharmaceuticals in Biological Fluids 433(26)
20.1 Bioanalysis
433(5)
20.1.1 Drug Development
434(1)
20.1.2 Therapeutic Drug Monitoring
435(1)
20.1.3 Forensic and Toxicological Analysis
436(1)
20.1.4 Doping Control Analysis
436(2)
20.2 Biological Fluids
438(2)
20.3 Bioanalytical Methods - An Overview
440(1)
20.4 Sampling
440(1)
20.5 Sample Preparation
441(5)
20.5.1 Protein Precipitation
441(2)
20.5.2 Liquid-Liquid Extraction
443(3)
20.5.3 Solid-Phase Extraction
446(1)
20.6 Separation and Detection
446(1)
20.7 Quantitation
447(6)
20.8 Screening
453(6)
21 Chemical Analysis of Biopharmaceuticals 459(46)
21.1 Biopharmaceuticals
459(4)
21.1.1 Amino Acids, the Building Blocks of Biopharmaceuticals
460(1)
21.1.2 Structure of Proteins
460(3)
21.1.3 Glycosylation of Proteins and Peptides
463(1)
21.2 Biopharmaceuticals versus Small Molecule APIs
463(1)
21.3 Biopharmaceuticals and Pharmacopoeias
464(1)
21.4 Production of Biopharmaceuticals
465(2)
21.5 Identification Procedures for Biopharmaceuticals (Active Substance)
467(21)
21.5.1 Peptide Mapping - Information About Primary Structure
468(8)
21.5.2 Separation Techniques
476(6)
21.5.3 Glycan Analysis
482(6)
21.5.4 Other Techniques
488(1)
21.6 Impurity Tests for Biopharmaceuticals (Active Substances)
488(10)
21.6.1 Impurities with Differing Molecular Masses
489(2)
21.6.2 Impurities with Different Charges/Charge Variants
491(4)
21.6.3 Total Protein/Protein Content
495(2)
21.6.4 Glycan Analysis
497(1)
21.7 Assay of Biopharmaceuticals (Active Substance)
498(2)
21.8 Monoclonal Antibodies
500(2)
21.9 Analysis of Biopharmaceutical Products
502(1)
21.10 Bioanalysis of Biopharmaceuticals Using LC-MS/MS
503(2)
Index 505
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 GRŲNHAUG HALVORSEN is Associate Professor at the Department of Pharmacy, University of Oslo.
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