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.