Profiles of drug substances, excipients, and related methodology / Harry G. Brittain.

Includes index.

pharmacy bookfair2016

Front Cover; Profiles of Drug Substances, Excipients, and Related Methodology; Copyright; Contents; Preface to Volume 39; Chapter One: Azithromycin; Background; 1. Description; 1.1. Nomenclature; 1.1.1. Systematic chemical names [2-5]; 1.1.2. Nonproprietary names; 1.1.3. Proprietary names [3,7,8]; 1.2. Formulae[2,3]; 1.2.1. Empirical formula, molecular weight, CAS number; 1.2.2. Structural formula; 1.3. Elemental analysis; 1.4. Appearance [2]; 2. Methods of Preparation of Azithromycin; 3. Physical Characteristics; 3.1. Specific optical rotation [5,21]; 3.2. Ionization constant [22]. 3.3. Solubility characteristics [21]3.4. Partition coefficient; 3.5. Particle morphology; 3.6. Crystallographic properties; 3.6.1. Single crystal structure; 3.6.2. X-ray powder diffraction pattern [28]; 3.7. Hygroscopicity; 3.8. Thermal methods of analysis; 3.8.1. Melting behavior; 3.8.2. Differential scanning calorimetry [25]; 3.8.3. Thermogravimetric analysis; 3.8.4. Karl Fischer titration (KFT) [25]; 3.8.5. Boiling point, enthalpy of vapor, flash point, and vapor pressure; 3.9. Spectroscopy; 3.9.1. UV/Vis spectroscopy; 3.9.2. Vibrational spectroscopy [32]. 3.9.3. Nuclear magnetic resonance spectrometry [33]3.9.3.1. 1H NMR spectrum [33]; 3.9.3.2. 13C NMR spectrum [33]; 3.10. Mass spectrometry [34]; 4. Methods of Analysis; 4.1. Compendial methods of analysis; 4.1.1. Identification; 4.1.1.1. IR spectrum of Azithromycin; 4.1.1.2. HPLC drug chromatogram; 4.1.2. Impurity Analysis [47]; 4.1.3. Other tests; 4.1.3.1. Water [47]; 4.1.3.2. Sulphated ash [47]; 4.1.4. Assay method [47]; 4.1.4.1. Liquid chromatography; 4.2. Electrochemical methods of analysis; 4.2.1. Voltammetry; 4.2.2. Coulometry; 4.3. Spectroscopic methods of analysis. 4.3.1. Spectrophotometry4.3.2. Spectrofluorimetry; 4.3.3. Colorimetry; 4.4. Chromatographic methods of analysis; 4.4.1. Electrophoresis; 4.4.2. Thin-layer chromatography; 4.4.3. High-performance liquid chromatography; 4.5. Determination in body fluids and tissues; 5. Stability; 6. Clinical Applications; 6.1. An overview; 6.2. Antimicrobial spectrum susceptibility; 6.3. Mechanism of action; 6.4. Resistance to macrolides; 6.5. Actions other than antimicrobial effects; 6.6. Clinical uses and dosing; 6.7. ADME profile; 6.8. Side effects; 6.9. Drug interactions; References; Chapter Two: Cefdinir. 1. Description1.1. Nomenclature; 1.1.1. Systematic chemical names; 1.1.2. Non-proprietary 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. Uses and Applications; 3. Methods of Preparation; 4. Physical Characteristics; 4.1. Ionization constant; 4.2. Solubility; 4.3. X-ray powder diffraction; 4.4. Thermal methods of analysis; 4.4.1. Melting point; 4.4.2. Differential scanning calorimetry; 5. Spectral Properties; 5.1. Ultraviolet spectroscopy.

Volumes in this widely revered series present comprehensive reviews of drug substances and additional materials, with critical review chapters that summarize information related to the characterization of drug substances and excipients. This organizational structure meets the needs of the pharmaceutical community and allows for the development of a timely vehicle for publishing review materials on this topic. The scope of the Profiles series encompasses review articles and database compilations that fall within one of the following six broad categories: Physical profiles of drug substances and excipients; Analytical profiles of drug substances and excipients; Drug metabolism and pharmacokinetic profiles of drug substances and excipients; Methodology related to the characterization of drug substances and excipients; Methods of chemical synthesis; and Reviews of the uses and applications for individual drug substances, classes of drug substances, or excipients.