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Profiles of drug substances, excipients, and related methodology
Annotation Profiles of Drug Substances, Excipients, and Related Methodology, Volume 43 presents comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. The series encompasses review articles and database compilations that fall within a variety of categories, with this release focusing on Ganciclovir, Mirtazapine, Tolfenamic Acid, Mid-Infrared Spectroscopy of Pharmaceutical Solids, and the Validation of Chromatographic Methods of Analysis: Application for drugs that derived from herbs.
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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