1st Edition

Pharmaceutical Analysis



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ISBN 9780849328145
Published November 7, 2003 by Blackwell
364 Pages

USD $200.00

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Book Description

A single-volume text, Pharmaceutical Analysis explores the analytical aspects of drug development and manufacture. Contributions by specialists from both the industrial and the academic sectors cover the entire range of techniques and applications from the analysis of minute amounts of complex biological materials to the quality control of the final dosage form. The book provides the information you need to choose the most suitable analytical technique for your particular purpose.

Table of Contents

QUALITY CONTROL AND REGULATION, C. Moores
Introduction
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
Conclusions and the Future of Regulatory Scrutiny

DEVELOPMENT OF ACHIRAL SEPARATION METHODS IN PHARMACEUTICAL ANALYSIS, G. Okafo and J.K. Roberts
Introduction
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, W.J. Lough
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, R.J. Smith and A.J. Edwards
Introduction
Strucuture Elucidation
On-Line Separations
Quantitation
Solid State NMR

MASS SPECTROMETRY IN PHARMACEUTICAL ANALYSIS, N. Haskins
Introduction
Mass Spectrometry
Strategies for Structural Elucidation
Structural Confirmation
Quantitation
Using the Data System

VIBRATIONAL SPECTROSCOPY IN PHARMACEUTICAL ANALYSIS, C.L. Anderton
Introduction
Vibrational Spectroscopy to Investigate Molecular Structure
Vibrational Spectrocsopy of Polymorphs, Hydrates and Solvates
Vibrational Spectroscopy for In Situ Characterisation
Summary

SOLID-STATE ANALYSIS AND POLYMORPHISM, U. Griesser, and J.G. Stowell
Introduction
Solid-State Properties of Drug Compounds
Methods of Solid-State Analysis
Summary

MICROSCOPY AND IMAGING IN PHARMACEUTICAL ANALYSIS, R.A. Carlton
Introduction
Solid-State Analysis
Particle Size and Morphology
Contaminant Identification
Conclusion

PROCESS ANALYSIS IN THE PHARMACEUTICAL INDUSTRY, M. Warman and S. Hammond
Introduction
Pharmaceutical Manufacturing
Conclusions

References
Index

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