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Introduction to Pharmaceutical Chemical Analysis

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Efnisyfirlit

  • Table of Contents
  • Preface
  • 1 Introduction to Pharmaceutical Analysis
    • 1.1 Applications and Definitions
    • 1.2 The Life of Medicines
    • 1.3 The Quality of Medical Products
    • 1.4 Summary
  • 2 International Pharmacopoeias, Regulations and Guidelines
    • 2.1 Overview of Legislation
    • 2.2 Legislation and Regulations for Industrial Production
    • 2.3 Life Time of Drugs and Drug Substances
    • 2.4 Pharmacopoeias
    • 2.5 International Harmonization
      • 2.5.1 International Conference on Harmonization
      • 2.5.2 Pharmacopoeial Discussion Group
    • 2.6 Legislation and Regulations for Pharmacy Production
    • 2.7 Summary
  • 3 Fundamental Chemical Properties, Buffers and pH
    • 3.1 pH and pKa
    • 3.2 Partition
    • 3.3 Stereochemistry
    • 3.4 Stability Testing
    • 3.5 Summary
  • 4 Fundamentals of Pharmaceutical Analysis
    • 4.1 What is a Pharmaceutical (Chemical) Analysis?
    • 4.2 How to Specify Quantities and Concentrations?
    • 4.3 Basic Laboratory Equipment
      • 4.3.1 The Analytical Balance
      • 4.3.2 Pipettes
      • 4.3.3 Volumetric Flasks
      • 4.3.4 Burettes
    • 4.4 How to Make Solutions and Dilutions
    • 4.5 Calibration of Analytical Methods
    • 4.6 Errors, Accuracy, and Precision
      • 4.6.1 Systematic and Random Errors
      • 4.6.2 Accuracy and Precision
    • 4.7 Statistics
      • 4.7.1 Mean Value and Standard Deviation
      • 4.7.2 Confidence Intervals
      • 4.7.3 Comparison of Means with a t-Test
      • 4.7.4 Q-Test to Reject Outliers
      • 4.7.5 Linear Regression with the Method of Least Squares
      • 4.7.6 How to Present an Analytical Result
    • 4.8 Some Words and Concepts
      • 4.8.1 Analysis and Determination
      • 4.8.2 Sample Replicates and Measuring Replicates
      • 4.8.3 Interference
      • 4.8.4 Blind Samples
  • 5 Titrimetric Methods
    • 5.1 Introduction
    • 5.2 Acid–Base Titrations
    • 5.3 Acid–Base Titrations in Non-Aqueous Media
    • 5.4 Redox Titrations
    • 5.5 Other Principles of Titration
    • 5.6 Summary
  • 6 Introduction to Spectroscopic Methods
    • 6.1 Electromagnetic Radiation
    • 6.2 Molecules and Electromagnetic Radiation
    • 6.3 Atoms and Electromagnetic Radiation
    • 6.4 Summary
  • 7 UV Spectrophotometry
    • 7.1 Principle of Quantitative Determination
    • 7.2 Principle of Identification
    • 7.3 Which Substances Have Strong UV Absorbance?
    • 7.4 Instrumentation
    • 7.5 Practical Work and Method Development
    • 7.6 Areas of Usage and Performance
    • 7.7 System Testing
    • 7.8 Summary
  • 8 IR Spectrophotometry
    • 8.1 IR Spectrophotometry
    • 8.2 Instrumentation
    • 8.3 Scope
    • 8.4 Instrument Calibration
    • 8.5 NIR Spectrophotometry
    • 8.6 Applications
    • 8.7 Summary
  • 9 Atomic Spectrometry
    • 9.1 Atomic Absorption Spectrometry
    • 9.2 Instrumentation
    • 9.3 Applications and Performance
    • 9.4 Practical Work and Method Development
    • 9.5 Atomic Emission Spectrometry
    • 9.6 Instrumentation
    • 9.7 Summary
  • 10 Chromatography
    • 10.1 General Principles
    • 10.2 Retention
    • 10.3 Column Efficiency
    • 10.4 Selectivity
    • 10.5 Peak Symmetry
    • 10.6 Resolution
    • 10.7 Chromatographic Techniques
    • 10.8 Summary
  • 11 Chromatographic Separation Principles
    • 11.1 General Introduction
    • 11.2 Normal Phase Chromatography
      • 11.2.1 Silica
      • 11.2.2 Interactions
      • 11.2.3 Order of Elution
      • 11.2.4 Other Stationary Phases
      • 11.2.5 Mobile Phases
      • 11.2.6 Summary of Normal Phase Chromatography
    • 11.3 Reversed Phase Chromatography
      • 11.3.1 Stationary Phases
      • 11.3.2 Retention Mechanisms
      • 11.3.3 Mobile Phases
      • 11.3.4 Ion-Pair Chromatography
      • 11.3.5 Summary of Reversed Phase Chromatography
    • 11.4 Hydrophilic Interaction Chromatography
    • 11.5 Chiral Separations
    • 11.6 Size Exclusion Chromatography
      • 11.6.1 Principle
      • 11.6.2 Summary of SEC
    • 11.7 Ion Exchange Chromatography
  • 12 Thin-Layer Chromatography
    • 12.1 Introduction
    • 12.2 Apparatus
    • 12.3 TLC Plates
    • 12.4 Stationary Phases
    • 12.5 Mobile Phases
    • 12.6 Chromatographic Development
    • 12.7 Detection
    • 12.8 Applications of TLC
    • 12.9 Quantitative Analysis and Instrumentation
    • 12.10 Summary
  • 13 High Performance Liquid Chromatography
    • 13.1 Introduction
    • 13.2 The Chromatographic Separation Process
    • 13.3 The Column
    • 13.4 Pumps
    • 13.5 Detectors
      • 13.5.1 UV detector
      • 13.5.2 Fluorescence Detector
      • 13.5.3 Electrochemical Detector
      • 13.5.4 Refractive Index, Evaporative Light Scattering and Corona Discharge Detectors
      • 13.5.5 Combination of Detectors
    • 13.6 Injectors
    • 13.7 Mobile Phases
    • 13.8 Solvents for Sample Preparation
    • 13.9 Reporting the Results
    • 13.10 Summary
  • 14 Gas Chromatography
    • 14.1 Introduction
    • 14.2 Apparatus
    • 14.3 Temperature
    • 14.4 Carrier Gas
    • 14.5 Stationary Phases
    • 14.6 Selectivity in GC
    • 14.7 Columns
      • 14.7.1 Capillary Columns
      • 14.7.2 Packed Columns
    • 14.8 Injection Systems
      • 14.8.1 Injection Systems for Capillary Columns
      • 14.8.2 Injection Systems for Packed Columns
    • 14.9 Detectors
      • 14.9.1 Flame Ionization Detector
      • 14.9.2 Nitrogen–Phosphorus Detector
      • 14.9.3 Thermal Conductivity Detector
      • 14.9.4 Electron Capture Detector
      • 14.9.5 Mass Spectrometry Detector
    • 14.10 Derivatization
      • 14.10.1 Silylation
      • 14.10.2 Alkylation
      • 14.10.3 Acylation
    • 14.11 The Uses of GC
    • 14.12 More Advanced GC techniques
    • 14.13 Summary
  • 15 Capillary Electrophoresis
    • 15.1 Principle and Theory
    • 15.2 Electroosmotic Flow
    • 15.3 Instrumentation
    • 15.4 The Capillary
    • 15.5 Sample Introduction
    • 15.6 Capillary Zone Electrophoresis; an Example
    • 15.7 Micellar Electrokinetic Chromatography
    • 15.8 Chiral Separations
    • 15.9 Coated Capillaries
    • 15.10 Non-Aqueous CE
    • 15.11 Summary
  • 16 Mass Spectrometry
    • 16.1 Introduction
    • 16.2 Basic Theory
    • 16.3 Electron Ionization
    • 16.4 Identification using Electron Ionization Spectra
    • 16.5 Characterization of Totally Unknowns using Electron Ionization Spectra
    • 16.6 Chemical Ionization
    • 16.7 Electrospray Ionization
    • 16.8 Atmospheric Pressure Chemical Ionization
    • 16.9 High-Resolution Mass Spectrometry
    • 16.10 Instrumentation
    • 16.11 Chromatography Coupled with Mass Spectrometry
    • 16.12 Quantitative GC-MS and LC-MS
    • 16.13 Areas of Usage and Performance
    • 16.14 Matrix-Assisted Laser Desorption/Ionization Mass Spectrometry
    • 16.15 Inductively Coupled Plasma Mass Spectrometry
    • 16.16 Summary
  • 17 Miscellaneous Chemical Techniques
    • 17.1 Potentiometric Determination of Ions using Ion-Selective Electrodes
    • 17.2 Paper Chromatography
    • 17.3 Supercritical Fluid Chromatography
    • 17.4 Gel Electrophoresis
    • 17.5 Iso-Electric Focusing
    • 17.6 Nuclear Magnetic Resonance Spectrometry
    • 17.7 Raman Spectrometry
  • 18 Sample Preparation
    • 18.1 Why is Sample Preparation Required?
    • 18.2 Main Strategies
    • 18.3 Recovery and Enrichment
    • 18.4 Protein Precipitation
    • 18.5 Liquid–Liquid Extraction
      • 18.5.1 Fundamentals
      • 18.5.2 A Closer Look at the Theory
      • 18.5.3 Extraction Solvents
      • 18.5.4 Calculation of Recovery
      • 18.5.5 Multiple Extractions
      • 18.5.6 LLE with Back-Extraction
    • 18.6 Solid–Liquid Extraction
    • 18.7 Solid Phase Extraction
      • 18.7.1 Fundamentals
      • 18.7.2 The SPE Column
      • 18.7.3 Conditioning
      • 18.7.4 Equipment
      • 18.7.5 Reversed-Phase SPE
      • 18.7.6 Secondary Interactions
      • 18.7.7 Ion Exchange SPE
      • 18.7.8 Mixed-Mode SPE
      • 18.7.9 Normal-Phase SPE
    • 18.8 Summary
  • 19 Analytical Chemical Characteristics of Selected Drug Substances
    • 19.1 Amitriptyline and Mianserin
    • 19.2 Morphine and Codeine
    • 19.3 Ibuprofen and Naproxen
    • 19.4 Furosemide
    • 19.5 Paracetamol (Acetaminophen)
    • 19.6 Neutral Drugs
  • 20 Quantification and Quality of Analytical Data
    • 20.1 Peak Height and Peak Area
    • 20.2 Calibration Methods
      • 20.2.1 External Standard Method
      • 20.2.2 Internal Standard Method
      • 20.2.3 Standard Addition
      • 20.2.4 Normalization
    • 20.3 Validation
      • 20.3.1 Analytical Procedure
      • 20.3.2 Accuracy
      • 20.3.3 Precision
      • 20.3.4 Specificity
      • 20.3.5 Detection Limit
      • 20.3.6 Quantification Limit
      • 20.3.7 Linearity and Range
      • 20.3.8 Robustness
      • 20.3.9 Test Methods in the European Pharmacopeia
    • 20.4 System Suitability
      • 20.4.1 Adjustment of Chromatographic Conditions
  • 21 Chemical Analysis of Drug Substances
    • 21.1 What is a Pharmaceutical Raw Material, how is it Produced and why must it be Controlled?
    • 21.2 The Pharmacopoeias – the Basis for Control of Pharmaceutical Raw Materials
    • 21.3 Which Contaminants are Found in Raw Materials, What are the Requirements in a Maximum Content a
      • 21.3.1 Well Defined Chemical Compounds
      • 21.3.2 Mixtures of Organic Compounds
    • 21.4 How to Check the Identity of Pharmaceutical Raw Materials
      • 21.4.1 Overview of the Identification Procedures
      • 21.4.2 Techniques used for the Identification of Well Defined Chemical Compounds
        • 21.4.2.1 Infrared Absorption Spectrophotometry
        • 21.4.2.2 Ultraviolet and Visible Absorption Spectrophotometry
        • 21.4.2.3 Thin-Layer Chromatography
        • 21.4.2.4 Melting Point
        • 21.4.2.5 Polarimetry
        • 21.4.2.6 High Performance Liquid Chromatography
        • 21.4.2.7 Chloride and Sulfate Identification
    • 21.5 How to Test for Impurities in Pharmaceutical Raw Materials
      • 21.5.1 Main Purity Tests for Well Defined Chemical Compounds
        • 21.5.1.1 Appearance of Solution
        • 21.5.1.2 Absorbance
        • 21.5.1.3 Acidity/Alkalinity
        • 21.5.1.4 Optical Rotation
        • 21.5.1.5 Related Substances
        • 21.5.1.6 Solvent Residues
        • 21.5.1.7 Foreign Anions
        • 21.5.1.8 Cationic Impurities
        • 21.5.1.9 Loss on Drying
        • 21.5.1.10 Determination of Water
      • 21.5.2 Purity Tests for Raw Materials of the Type of Mixtures of Organic Compounds
        • 21.5.2.1 Oxidizing Substances
        • 21.5.2.2 Acid Value
        • 21.5.2.3 Hydroxyl Value
        • 21.5.2.4 Iodine Value
        • 21.5.2.5 Peroxide Value
        • 21.5.2.6 Saponification Value
        • 21.5.2.7 Unsaponifiable Matter
        • 21.5.2.8 Other Tests
      • 21.5.3 Identification of the Raw Materials of the Type of Mixtures of Organic Compounds
    • 21.6 How to Determine the Purity of Pharmaceutical Raw Materials
      • 21.6.1 Acid–Base Titration in Aqueous Environment
      • 21.6.2 Acid–Base Titration in a Non-Aqueous Environment
      • 21.6.3 Redox Titrations
      • 21.6.4 High Performance Liquid Chromatography
      • 21.6.5 UV spectrophotometry
    • 21.7 How to Control Compounds for Which no Pharmacopoeia Monograph Exists
    • 21.8 How are Ph.Eur. and USP Updated?
  • 22 Chemical Analysis of Final Pharmaceutical Products
    • 22.1 Quality Control of Final Pharmaceutical Products
    • 22.2 Monographs and Chemical Testing
    • 22.3 Identification of the Active Pharmaceutical Ingredient
    • 22.4 Assay of the Active Pharmaceutical Ingredient
    • 22.5 Chemical Tests for Final Pharmaceutical Products
      • 22.5.1 Test for Related Substances
      • 22.5.2 Uniformity of Content
      • 22.5.3 Dissolution
  • 23 Analysis of Drugs in Biological Fluids
    • 23.1 Introduction
      • 23.1.1 Drug Development
      • 23.1.2 Therapeutic Drug Monitoring
      • 23.1.3 Forensic and Toxicological Analysis
      • 23.1.4 Doping Control Analysis
    • 23.2 The Biological Matrix
    • 23.3 Bioanalytical Methods
      • 23.3.1 Sampling
      • 23.3.2 Sample Preparation
      • 23.3.3 Protein Precipitation
      • 23.3.4 Liquid–Liquid Extraction
      • 23.3.5 Solid-Phase Extraction
      • 23.3.6 Separation
      • 23.3.7 Detection
      • 23.3.8 Calibration and Quantification
    • 23.4 Examples
      • 23.4.1 Sample Preparation
        • 23.4.1.1 Sample Preparation Procedure by LLE
        • 23.4.1.2 Comments to the Procedure
        • 23.4.1.3 Sample Preparation Procedure by LLE and Back Extraction
        • 23.4.1.4 Comments to the Procedure
        • 23.4.1.5 Sample Preparation Procedure by SPE
        • 23.4.1.6 Comments to the Procedure
        • 23.4.1.7 Sample Preparation Procedure by Protein Precipitation
        • 23.4.1.8 Comments to the Procedure
      • 23.4.2 Quantitative Determination
        • 23.4.2.1 Quantitative Determination of Amitriptyline in Serum by LC-MS
        • 23.4.2.2 Comments to the Procedure
        • 23.4.2.3 Determination of Valproic Acid in Serum by GC-MS
        • 23.4.2.4 Comments to the Procedure
      • 23.4.3 Identification
        • 23.4.3.1 Sample Preparation Procedure for Unknown Screening by Mixed Mode Cation Exchange
        • 23.4.3.2 Comments to the Procedure
        • 23.4.3.3 GC-MS Procedure for Unknown Screening
        • 23.4.3.4 Comments to the Procedure
        • 23.4.3.5 LC-MS-MS Procedure for Unknown Screening
        • 23.4.3.6 Comments to the Procedure
  • Index

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Vörumerki: John Wiley
Tilboði lýkur 23.04.2019
Vörunúmer: 9781119282037
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Introduction to Pharmaceutical Chemical Analysis

Vörumerki: John Wiley
Vörunúmer: 9781119282037
Rafbók

Veldu vöru

Tilboði lýkur eftir
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Get the product now
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