Pharmaceutical Analysis explores the analytical aspects of drug development and manufacture.

Features:

• Provides an up-to-date overview of the philosophy and practicalities of working in a regulated environment
• Brings together coverage of a wide range of analytical techniques and applications into one volume
• Discusses the importance of chiral analysis and the development of new techniques across the scientific disciplines
• Highlights the development and widespread use of coupled techniques including state-of-the-art LC/NMR, multi-nuclear NMR, computer-aided spectral interpretation, quantitative NMR, and solid-state NMR
• Explores the instrumental capabilities of mass spectroscopy and their applications in structure elucidation and quantitative analysis

Contents

Quality Control and Regulation

• The Quality of Medicines
• General Quality System Requirements
• Good Laboratory Practice (GLP)
• Good Manufacturing Practice (GMP)
• International Harmonisation of Quality Standards
• Regulatory Inspection Key Areas
• Quality Control, Quality Assurance and Regulatory Filings
• Regulatory Inspection Key Areas

Development of Achiral Separation Methods in Pharmaceutical Analysis

• General Guidance for Method Development in Separation Sciences
• High Performance Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• Capillary Electrographic Techniques
• Other Separation Techniques
• Hyphenated Separation Techniques
• Use of Automated Approaches to Method Development in Chromatography
• Use of Chemometric Approaches to Method Development

Chiral Analysis of Pharmaceuticals

• Significance of Chirality in Pharmaceutical R&D
• Evolution of Methodologies for Chiral Resolution
• Recent Developments in Commercial CSP for LC
• Role of Historical CSP
• Chiral Drug Bioanalysis
• Preparative Chiral Separations
• Present and Future Perspectives

Nuclear Magnetic Resonance Spectroscopy in Pharmaceutical Analysis

• Strucuture Elucidation
• On-Line Separations
• Quantitation
• Solid State NMR

Mass Spectrometry in Pharmaceutical Analysis

• Mass Spectrometry
• Strategies for Structural Elucidation
• Structural Confirmation
• Quantitation
• Using the Data System

Vibrational Spectroscopy in Pharmaceutical Analysis

• Vibrational Spectroscopy to Investigate Molecular Structure
• Vibrational Spectrocsopy of Polymorphs, Hydrates and Solvates
• Vibrational Spectroscopy for In Situ Characterisation

Solid-State Analysis and Polymorphism

• Solid-State Properties of Drug Compounds
• Methods of Solid-State Analysis

Microscopy and Imaging in Pharmaceutical Analysis

• Solid-State Analysis
• Particle Size and Morphology
• Contaminant Identification

Process Analysis in the Pharmaceutical Industry

• Pharmaceutical Manufacturing

Index

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