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Profiles of Drug Substances, Excipients, and Related Methodology /

Profiles of Drug Substances, Excipients, and Related Methodology, Volume 49 provides timely and pertinent information on a variety of timely topics, including Physical Profiles of Drug Substances and Excipients; Analytical Profiles of Drug Substances and Excipients; ADME Profiles of Drug Substances...

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Bibliographic Details
Corporate Author: ScienceDirect (Online service)
Other Authors: Al-Majed, Abdulrahman (Editor)
Format: eBook
Language:English
Published: London, England : Academic Press, [2024]
Edition:First edition.
Series:Profiles of drug substances, excipients, and related methodology ; Volume 49.
Subjects:
Pharmaceutical chemistry.
Chemistry, Pharmaceutical
Chimie pharmaceutique.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Front Cover
  • Series Page
  • Title Page
  • Copyright
  • Contents
  • Contributors
  • Preface
  • Chapter One: Deferasirox: A comprehensive drug profileDeferasirox: A comprehensive drug profile
  • 1 Description
  • 1.1 History
  • 1.2 Nomenclature
  • 1.2.1 Systemic chemical name
  • 1.2.2 Nonproprietary names
  • 1.2.3 Proprietary names
  • 1.3 Formulae
  • 2 Mode of action
  • 3 Pharmacokinetics
  • 4 Indications
  • 5 Synthesis
  • 6 Physical characteristics
  • 6.1 Solubility
  • 6.2 Dissociation constant
  • 6.3 Optical activity
  • 6.4 Density
  • 6.5 Partition coefficient
  • 6.6 Melting behavior
  • 6.7 Lattice analysis by X-ray powder diffraction
  • 6.8 Thermal analysis
  • 6.9 FTIR spectroscopy
  • 6.10 NMR spectroscopic analysis
  • 7 Methods of analysis
  • 7.1 Reversed phase-high performance liquid chromatography (RP-HPLC) method
  • 7.2 Liquid chromatography combined with tandem mass spectrometry (LC-MS/MS) methods
  • 7.3 Spectrophotometric methods
  • 7.4 Fluorescence methods
  • Acknowledgment
  • References
  • Chapter Two: Duvelisib: A comprehensive profile
  • 1 Description
  • 1.1 Nomenclature
  • 1.1.1 Systemic chemical names [1]
  • 1.1.2 Nonproprietary names [1]
  • 1.2 Formulae
  • 1.2.1 Empirical formula
  • 1.2.2 Structural formula
  • 1.3 Elemental composition
  • 1.4 Appearance [2,3]
  • 1.5 Physicochemical properties [4,5]
  • 2 Uses and applications
  • 3 Methods of preparation
  • 4 Spectroscopic analysis
  • 4.1 Ultraviolet-visible spectroscopy
  • 4.2 Fluorescence spectroscopy
  • 4.3 Fourier-transform infrared absorption spectroscopy
  • 4.4 1H-nuclear magnetic resonance spectrometry
  • 4.5 Mass spectrometry
  • 5 Thermogravimetric analysis
  • 6 Methods of analysis
  • 6.1 Compendial method
  • 6.2 Spectroscopic methods
  • 6.2.1 Ultraviolet-visible spectrophotometry
  • 6.2.2 Spectrofluorometry
  • 6.3 Chromatographic methods
  • 7 Pharmacological properties.
  • 7.1 Mechanism of action
  • 7.2 Pharmacokinetics
  • 8 Dosing information
  • 8.1 Dosage forms and administration
  • 8.2 Contraindications
  • 8.3 Adverse reactions
  • 8.4 Warning and precautions
  • 8.4.1 Infections
  • 8.4.2 Diarrhea or colitis
  • 8.4.3 Cutaneous reactions
  • 8.4.4 Pneumonitis
  • 8.4.5 Hepatotoxicity
  • 8.4.6 Neutropenia
  • 8.4.7 Embryo-fetal toxicity
  • 8.5 Use in specific population
  • 8.5.1 Pregnancy
  • 8.5.2 Breastfeeding
  • 8.5.3 Pediatric use
  • 8.5.4 Hepatic impairment
  • 8.5.5 Renal impairment
  • References
  • Chapter Three: Regorafenib: A comprehensive drug profile
  • 1 Description
  • 1.1 Nomenclature
  • 1.1.1 Systematic chemical names [1]
  • 1.1.2 Nonproprietary names [1]
  • 1.1.3 Proprietary names [1]
  • 1.2 Formulae [1]
  • 1.2.1 Empirical formula, molecular weight, CAS number
  • 1.2.2 Structural formula [1]
  • 1.2.3 Simplified molecular input line entry system (SMILES) [1]
  • 1.2.4 The IUPAC international chemical identifier (InChI) [1]
  • 1.3 Elemental analysis
  • 1.4 Appearance [2]
  • 2 Physical characteristics
  • 2.1 Ionization constants
  • 2.2 Solubility characteristics
  • 2.3 Partition coefficients
  • 2.4 Crystallographic properties
  • 2.4.1 X-ray powder diffraction pattern
  • 2.5 Thermal methods of analysis
  • 2.5.1 Melting behavior
  • 2.5.2 Differential scanning calorimetry (DSC)
  • 2.6 Spectroscopic identification
  • 2.6.1 UV/VIS spectroscopy
  • 2.6.2 Vibrational spectroscopy
  • 2.7 Nuclear magnetic resonance spectrometry
  • 2.7.1 1H NMR spectrum
  • 2.7.2 13C NMR spectrum
  • 2.8 Mass spectrometry
  • 3 Methods of preparation
  • 4 Methods of analysis
  • 4.1 Electrochemical methods of analysis
  • 4.2 Spectrophotometric methods of analysis
  • 4.3 Chromatographic methods of analysis
  • 5 Pharmacology
  • 5.1 Pharmacokinetics
  • 5.1.1 Absorption
  • 5.1.2 Distribution
  • 5.1.3 Elimination
  • 5.1.4 Metabolism.
  • 5.1.5 Excretion
  • 5.2 Pharmacological effects
  • 5.3 Drug-drug interactions
  • References
  • Chapter Four: Ponatinib: A comprehensive drug profile
  • 1 General information
  • 1.1 Nomenclature
  • 1.1.1 Systematic chemical names
  • 1.1.1.1 Ponatinib base [1]
  • 1.1.1.2 Ponatinib hydrochloride
  • 1.1.2 Non-proprietary names (generic names)
  • 1.1.3 Proprietary names (brand 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 Physical characteristics
  • 2.1 Dissociation constants
  • 2.2 Solubility characteristics
  • 2.3 Partition coefficients
  • 2.4 Crystallographic properties
  • 2.4.1 Single crystal structure [9]
  • 2.4.2 X-ray powder diffraction pattern
  • 2.5 Thermal gravimetric analysis (TGA)
  • 2.6 Spectroscopy
  • 2.6.1 Ultraviolet spectroscopy
  • 2.6.2 Nuclear magnetic resonance spectrometry
  • 2.6.2.1 1H NMR spectrum
  • 2.6.2.2 13C NMR spectrum
  • 2.6.3 Infrared spectroscopy
  • 2.7 Mass spectrometry
  • 3 Uses and applications
  • 4 Stability
  • 5 Preparation of ponatinib
  • 6 Impurities
  • 7 Reported methods of analysis
  • 7.1 Electrochemical approach
  • 7.2 Spectroscopic methods of analysis
  • 7.2.1 Spectrofluorimetric method
  • 7.2.2 Stimulated raman scattering (SRS) microscopy
  • 7.3 Chromatographic methods of analysis
  • 7.4 Immunoassay
  • 8 Clinical pharmacology
  • 8.1 Mechanism of action
  • 8.2 Pharmacokinetics
  • 8.2.1 Absorption
  • 8.2.2 Distribution
  • 8.2.3 Metabolism
  • 8.2.4 Excretion
  • 8.2.5 Special populations
  • 8.3 Pharmacodynamics
  • 8.4 Dosage
  • 8.5 Adverse effects
  • 8.6 Drug interactions
  • References
  • Chapter Five: Avanafil: A comprehensive drug profile
  • 1 Description
  • 1.1 Nomenclature
  • 1.1.1 IUPAC names
  • 1.1.1.1 Avanafil
  • 1.1.1.2 Avanafil dibenzenesulfonate
  • 1.1.2 Nonproprietary name.
  • 1.1.3 Proprietary names
  • 1.2 Formulae
  • 1.2.1 Empirical formula, molecular weight, and CAS no
  • 1.2.2 Structural formula
  • 1.3 Elemental analysis
  • 2 Methods of preparation of avanafil
  • 3 Physical characteristics
  • 3.1 Physical appearance
  • 3.2 Specific rotation
  • 3.3 Melting point
  • 3.4 Dissociation constant
  • 3.5 Solubility and partition coefficient
  • 3.6 Stability
  • 3.7 Crystallographic properties
  • 3.8 Thermal analysis
  • 3.9 Spectroscopy
  • 3.9.1 UV/Vis spectroscopy
  • 3.9.2 Spectrofluorimetric method
  • 3.9.3 Infrared spectroscopy
  • 3.9.3.1 Mass spectroscopy
  • 3.9.4 NMR spectroscopy
  • 3.9.4.1 1H NMR spectroscopy
  • 3.9.5 13C NMR spectroscopy
  • 4 Methods of analysis
  • 4.1 Compendial method
  • 4.2 Reported methods of analysis
  • 4.2.1 Electrochemical methods
  • 4.2.2 Spectroscopic methods
  • 4.2.2.1 Colorimetric method
  • 4.2.2.2 Spectrophotometry method
  • 4.2.2.3 Spectrofluorimetric method
  • 4.2.3 Capillary electrophoresis
  • 4.2.4 Chromatography
  • 4.2.4.1 High-performance thin-layer chromatography (HPTLC) methods
  • 4.2.4.2 High-performance liquid chromatography methods
  • 4.2.4.3 Liquid chromatography-tandem mass spectrometric methods (LC/MS)
  • 4.2.4.4 Gas chromatography-mass spectrometry (GC/MS)
  • 5 Stability
  • 6 Clinical pharmacology of avanafil
  • 6.1 Mechanism of action
  • 6.2 Pharmacokinetics
  • 6.2.1 Absorption
  • 6.2.2 Distribution
  • 6.2.3 Metabolism
  • 6.2.4 Elimination
  • 6.2.5 Special populations
  • 6.3 Dosage and administration
  • 6.4 Drug interactions
  • 6.5 Adverse effects
  • 6.6 Effects on the body
  • References
  • Chapter Six: Regulation and standardization of herbal drugs: Current status, limitation, challenge's and future prospective
  • 1 Introduction
  • 2 Regulation of herbal drugs
  • 2.1 US Food and Drug Administration (FDA)
  • 2.2 European Medicines Agency (EMA).
  • 2.3 Pharmaceutical and Medical Devices Agency (PMDA) of Japan
  • 2.4 Ministry of Health and Welfare Taiwan, Republic of China
  • 2.5 Chinese Medicine Regulatory Office, Department of Health, The Government of Hong Kong Special Administrative Region
  • 2.6 Indonesian National Agency of Drug and Food Control (BPOM-RI)
  • 2.7 Summary and discussions
  • 3 Standardization of herbal drugs: current criteria and limitations
  • 3.1 Sampling and identification
  • 3.2 Quantitative determination
  • 3.3 Specific tests
  • 3.4 Microbial quality tests
  • 3.5 Summary and discussion
  • 4 Challenges and future perspective of HD standardization methods
  • 4.1 Qualitative method (identification)
  • 4.2 Quantitative analysis and limit tests
  • 5 Summary and recommendations
  • Acknowledgments
  • References
  • Cumulative index
  • Back Cover.