Profiles of drug substances, excipients, and related methodology. Volume 43 /

Annotation

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Brittain, H. G. (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cambridge, MA : Academic Press, imprint of Elsevier, 2018.
Edición:First edition.
Colección:Profiles of drug substances, excipients, and related methodology ; 43.
Temas:
Drugs.
Excipients.
Pharmaceutical Preparations > analysis
Excipients > analysis
Pharmaceutical Preparations
M�edicaments.
MEDICAL > Pharmacology.
Drugs
Excipients
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Cover
  • Profiles of Drug Substances, Excipients, and Related Methodology
  • Copyright
  • Contents
  • Contributors
  • Preface to Volume 43
  • Chapter One: Ganciclovir
  • 1. Description
  • 1.1. Nomenclature
  • 1.1.1. Chemical Names
  • 1.1.2. Nonproprietary Names
  • 1.1.3. Proprietary Names
  • 1.2. Formulae
  • 1.2.1. Ganciclovir
  • 1.2.2. Ganciclovir Sodium
  • 1.2.3. Structural
  • 1.3. Elemental Composition
  • 1.4. Appearance
  • 2. Uses and Applications
  • 3. Methods of Preparation
  • 3.1. Method 1
  • 3.2. Method 2
  • 3.3. Method 3
  • 3.4. Method 4
  • 3.5. Method 5
  • 3.6. Method 6
  • 3.7. Method 7
  • 3.8. Method 8
  • 3.9. Method 9
  • 3.10. Method 10
  • 3.11. Method 11
  • 4. Physical Characteristics
  • 4.1. Ionization Constant
  • 4.2. Solubility
  • 4.3. Partition Coefficient
  • 4.4. X-Ray Analysis
  • 4.4.1. X-Ray Powder Diffraction Pattern
  • 4.4.2. Crystal Structure
  • 4.4.3. Studies of Crystal Modification
  • 4.4.3.1. Experimental
  • 4.4.3.1.1. Materials
  • 4.4.3.1.2. Methodology and Instrumentation
  • 4.4.3.1.2.1. Powder X-Ray Diffractometry
  • 4.4.3.1.2.2. Variable-Temperature Powder X-Ray Diffraction
  • 4.4.3.1.2.3. Fourier Transform Infrared Spectroscopy
  • 4.4.3.1.2.4. Near-Infrared Spectroscopy
  • 4.4.3.1.2.5. Differential Scanning Calorimetry
  • 4.4.3.1.2.6. Thermogravimetric Analysis
  • 4.4.3.2. Results and Discussion
  • 4.4.3.2.1. Powder X-Ray Diffractometry
  • 4.4.3.2.2. Variable-Temperature/Humidity Powder X-Ray Diffraction
  • 4.4.3.2.3. FTIR Spectroscopy
  • 4.4.3.2.4. Near-IR Spectroscopy
  • 4.4.3.2.5. Thermal Analysis
  • 4.4.3.3. Summary of the Crystal Modification Studies
  • 4.4.4. Reviewing Aspects of Crystal Forms
  • 4.4.4.1. Experimental Section
  • 4.4.4.1.1. Materials and Methods
  • 4.4.4.1.2. Isolation of Form III as Bulk Powders
  • 4.4.4.1.3. Isolation of Ganciclovir Form IV as Bulk Powders.
  • 4.4.4.1.4. Isolation of Ganciclovir Forms III and IV as Single Crystals
  • 4.4.4.1.5. Synthesis of Ganciclovir Hydrochloride Salt as Bulk Powders
  • 4.4.4.1.6. Single-Crystal X-Ray Diffraction Structure Determination of Ganciclovir Form III
  • 4.4.4.1.7. X-Ray Powder Diffraction of Ganciclovir Structural Characterization
  • 4.4.4.1.8. Variable-Temperature Powder X-Ray Diffraction of Ganciclovir
  • 4.4.4.2. Results and Discussion
  • 4.4.4.2.1. Isolation of the Different Crystal Phases
  • 4.4.4.2.2. Structural Characterization
  • 4.4.4.2.2.1. Crystal and Molecular Structure of Ganciclovir Form II
  • 4.4.4.2.2.2. Crystal and Molecular Structure of Ganciclovir Form III
  • 4.4.4.2.2.3. Crystal and Molecular Structure of Ganciclovir Form IV
  • 4.4.4.2.2.4. Crystal and Molecular Structure of Ganciclovir Hydrochloride
  • 4.4.4.2.2.5. Crystal and Molecular Structure of Compound Ganciclovir A2
  • 4.4.4.2.2.6. Crystal and Molecular Structure of Compound Ganciclovir A3
  • 4.4.4.2.3. Thermal Behavior
  • 4.4.4.3. Summary of the Crystal Forms Studies
  • 4.5. Thermal Methods of Analysis
  • 4.5.1. Melting Behavior
  • 4.5.2. Differential Scanning Calorimetry
  • 4.5.3. Thermogravimetry
  • 4.6. Spectroscopy
  • 4.6.1. Ultraviolet Spectroscopy
  • 4.6.2. Vibrational Spectroscopy
  • 4.6.3. Nuclear Magnetic Resonance Spectrometry
  • 4.6.3.1. 1H NMR Spectrometry
  • 4.6.3.2. 13C NMR Spectrometry
  • 4.6.4. Mass Spectrometry
  • 5. Methods of Analysis
  • 5.1. United States Pharmacopoeia Methods
  • 5.1.1. Ganciclovir Bulk Drug
  • 5.1.2. Ganciclovir for Injection
  • 5.2. Spectrophotometry
  • 5.3. Voltammetry
  • 5.4. Chemiluminescence
  • 5.5. High-Performance Liquid Chromatography
  • 5.6. Liquid Chromatography/MS/MS
  • 5.7. Electrophoresis
  • 5.8. Radioimmunoassay
  • 6. Biological Investigations
  • 6.1. Pharmacokinetics
  • 6.2. Metabolism
  • 6.3. Bioavailability.
  • 6.4. Evaluations and Monitorings
  • 7. Stability
  • 8. Reviews
  • Acknowledgments
  • References
  • Chapter Two: Mirtazapine
  • 1. Description
  • 1.1. Nomenclature
  • 1.1.1. Systematic Chemical Names
  • 1.1.2. Nonproprietary Names
  • 1.1.2.1. Generic Names
  • 1.1.2.2. Foreign Names
  • 1.1.3. Proprietary Names
  • 1.2. Formulae
  • 1.2.1. Empirical Formula, Molecular Weight, and CAS Number
  • 1.2.2. Structural Formula
  • 1.3. Elemental Analysis
  • 1.4. Appearance
  • 2. Methods of Preparation
  • 3. Physical Characteristics
  • 3.1. Ionization Constant
  • 3.2. Solubility Characteristics
  • 3.3. Optical Activity (Rotation)
  • 3.4. X-Ray Powder Diffraction Pattern
  • 3.5. Thermal Methods of Analysis
  • 3.5.1. Melting Behavior
  • 3.5.2. Differential Scanning Calorimetry
  • 3.5.3. Thermogravimetric Analysis
  • 3.5.4. Mirtazapine Chemical Properties
  • 3.6. Spectroscopy
  • 3.6.1. Ultraviolet Spectroscopy
  • 3.6.2. Fourier-Transform Infrared Absorption Spectroscopy
  • 3.6.3. Mass Spectrometry
  • 3.6.4. NMR Spectrometry
  • 3.6.4.1. 1H NMR Spectrometry
  • 3.6.4.2. 13C NMR Spectrometry
  • 4. Methods of Analysis
  • 4.1. Compendial Methods of Analysis
  • 4.1.1. Identification
  • 4.1.1.1. Bulk Drug Substance
  • 4.1.1.2. Drug Substance in Pharmaceutical Preparations
  • 4.1.2. Assays
  • 4.1.2.1. Bulk Drug Substance
  • 4.1.2.2. Tablets
  • 4.1.3. Impurity Analyses
  • 4.1.3.1. Impurities in Drug Substance and Pharmaceutical Preparations
  • 4.1.4. Other Tests
  • 4.1.4.1. Sulfated Ash/Residue on Ignition
  • 4.1.4.2. Heavy Metals
  • 4.1.4.3. Optical Rotation
  • 4.2. Reported Methods of Analysis
  • 4.2.1. Titrimetric Methods
  • 4.2.2. Spectrophotometric Methods
  • 4.2.2.1. Ultraviolet Spectrometric Methods
  • 4.2.2.2. Colorimetric Methods
  • 4.2.2.3. Spectrofluorimetric Methods
  • 4.2.3. Electrochemical Methods
  • 4.2.3.1. Voltammetric Methods
  • 4.2.3.2. Polarographic Methods.
  • 4.2.4. Chromatographic Methods
  • 4.2.4.1. Thin-Layer Chromatographic Methods
  • 4.2.4.2. Gas Chromatographic Methods
  • 4.2.4.3. High-Performance Liquid Chromatographic Methods
  • 4.2.4.4. Electrophoresis Method
  • 5. Stability
  • 6. Pharmacological Profile
  • 7. Clinical Pharmacokinetics
  • 7.1. Absorption
  • 7.2. Distribution
  • 7.3. Metabolism
  • 7.4. Elimination
  • Acknowledgment
  • References
  • Chapter Three: Tolfenamic Acid
  • 1. Introduction
  • 2. Description
  • 2.1. Taxonomy
  • 2.2. Nomenclature
  • 2.2.1. Chemical Names
  • 2.2.2. Generic Names
  • 2.2.3. Proprietary Names
  • 2.3. Chemical Structure
  • 2.4. Chemical Formula and Molecular Weight
  • 2.5. Elemental Analysis
  • 2.6. Registry Numbers
  • 2.7. International Chemical Identifier Key
  • 2.8. Canonical SMILES
  • 2.9. Impurities
  • 2.10. Copper Content
  • 2.11. Sulfated Ash Content
  • 2.12. Packaging and Storage
  • 3. Synthesis
  • 4. Physical Characteristics
  • 4.1. Appearance, Color, and Form
  • 4.2. Clarity and Color of Solution
  • 4.3. Solubility
  • 4.4. Thermodynamic Characteristics
  • 4.5. Acidity
  • 4.6. Dissociation Constant
  • 4.7. Partition Coefficient
  • 4.8. Vapor Pressure
  • 4.9. Surface Tension
  • 4.10. Loss on Drying
  • 4.11. Micromeritics
  • 4.12. Polymorphism
  • 4.12.1. Preparation of Yellow and White Polymorphic Forms of TA
  • 4.13. Crystallographic Properties
  • 4.14. Spectroscopy
  • 4.14.1. Ultraviolet (UV) Spectroscopy
  • 4.14.2. Vibrational Spectroscopy
  • 4.14.2.1. Infrared (IR) Absorption Spectroscopy
  • 4.14.2.2. Raman Spectroscopy
  • 4.14.3. Fluorescence Spectroscopy
  • 4.14.4. Nuclear Magnetic Resonance Spectrometry
  • 4.14.5. Mass spectrometry
  • 5. Identification Tests
  • 5.1. FTIR Spectroscopy
  • 5.2. UV Spectroscopy
  • 5.3. Thin-Layer Chromatography
  • 6. Methods of Analysis
  • 6.1. Titrimetric Method
  • 6.2. Spectrophotometric Methods.
  • 6.2.1. UV Spectroscopy
  • 6.2.2. IR Spectroscopy
  • 6.2.3. Raman Spectroscopy
  • 6.2.4. Fluorescence Spectroscopy
  • 6.2.5. NMR Spectroscopy
  • 6.2.6. Mass Spectrometry
  • 6.3. Chromatographic Methods
  • 6.3.1. Thin-Layer Chromatography
  • 6.3.2. Ion Chromatography
  • 6.3.3. High-Performance Liquid Chromatography
  • 6.3.3.1. Liquid Chromatography-Mass Spectrometry
  • 6.3.4. Gas Chromatography-Mass Spectrometry
  • 6.4. Electrochemical Method
  • 6.5. Solid-State Techniques
  • 6.5.1. X-ray Crystallography
  • 6.5.2. X-ray Powder Diffraction
  • 6.6. Thermal Methods
  • 6.6.1. Thermogravimetric Analysis
  • 6.6.2. Differential Scanning Calorimetry
  • 6.7. Microscopic Methods
  • 6.7.1. Scanning Electron Microscopy
  • 6.7.2. Optical Microscopy
  • 6.8. Enzymatic Assay
  • 7. Dissolution Studies
  • 8. Stability and Degradation
  • 8.1. Effect of Light
  • 8.2. Effect of Temperature
  • 8.3. Effect of pH
  • 8.4. Effect of Solvent Dielectric Constant and Viscosity
  • 8.5. Solution Stability
  • 9. Pharmacology
  • 9.1. Mechanism of Action
  • 9.2. Therapeutic Uses
  • 9.2.1. Pain and Other Related Disorders
  • 9.2.2. Cancers
  • 9.2.3. Alzheimer's Disease
  • 9.2.4. Antibacterial Activity
  • 10. Pharmacokinetics
  • 10.1. Humans
  • 10.2. Animals
  • 11. Dosage/Dose
  • 12. Adverse Effects/Toxicity
  • 13. Drug Interactions
  • References
  • Chapter Four: Mid-Infrared Spectroscopy of Pharmaceutical Solids
  • 1. Introduction
  • 2. Correlated Motion of Atoms in Molecules
  • 3. Mid-Infrared Spectroscopy of Polyatomic Molecules
  • 4. Instrumentation and Sampling Possibilities for Measurement of Infrared Spectra in the Solid State
  • 5. Applications of Infrared Spectroscopy to Pharmaceutically Interesting Drug Substances
  • 5.1. Qualitative Identification of Pharmaceutical Compounds
  • 5.2. Infrared Spectroscopic Studies of Drug Substances: Polymorphism.

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