Pharmaceutical Analysis: 1st Edition (Hardback) book cover

Pharmaceutical Analysis

1st Edition

By David Lee, Michael Webb

Blackwell

364 pages

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Hardback: 9780849328145
pub: 2003-11-07
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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

About the Series

Sheffield Analytical Chemistry

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Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013010
SCIENCE / Chemistry / Analytic