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[资源] 现代药物分析第二版

INTRODUCTION：
Modern pharmaceutical analysis encompasses much more than analysis of
active pharmaceutical ingredients (APIs), inert ingredients (excipients), or
formulated drug product (DP). The primary goal of pharmaceutical analysis is
to assure drug quality. It is well known that quality cannot be tested into a product;
however, well-planned testing with suitable methodology and instrumentation
can help build quality into a DP.1 A thorough understanding of interactions of
drug substances with excipients is necessary, especially when residual solvents
(including moisture) are present. It is also essential to understand potential degradation
reactions that may occur in the formulated product under various stress
conditions that might be encountered during storage and in shipment of the final
package. And dissolution tests should correlate well with the bioavailability.
In short, the aim of pharmaceutical analysis is to help build and assure quality
of DPs. Recognition of these principles has encouraged the Food and Drug Administration
(FDA) to issue the new initiative quality by design (QbD) outlined in the
May 2007 FDA report “Pharmaceutical Quality for the 21st Century: A Risk-
Based Approach.” The focus of this concept is that quality should be built into
a product by means of a thorough understanding of the product and the process
by which it is developed and manufactured, along with a knowledge of the risks
involved in manufacturing the product and how best to mitigate those risks
through continuous product improvement.
This second edition of Handbook of Modern Pharmaceutical Analysis
addresses QbD and other new developments such as the best ways to monitor
genotoxic impurities (GTIs), separations of chiral compounds, and characterization
and analysis of biopharmaceutical proteins. The first edition published in
2001 has been a popular text among individuals in the pharmaceutical industry
who are involved in drug development and the associated analytical function area.
That book provided a journey through the drug development process, with
emphasis on the role of analytical chemistry. It covered various separation
methods such as thin layer chromatography (TLC), gas chromatography (GC),
high-pressure or high-performance liquid chromatography (HPLC), and capillary
electrophoresis (CE) that are commonly used in the pharmaceutical industry for
the evaluation of a large variety of samples. These methods still remain the methods
of choice for checking purity of new drug candidates, monitoring changes or scaleup
of synthetic procedures, evaluating new formulations, and implementing quality
control/assurance of final DPs. Hyphenated methods that combine a chromatographic
method with spectroscopic methods such as mass spectrometry (MS)
or nuclear magnetic resonance (NMR) have been found useful for characterizing
impurities; these methods are fully covered in that text. The aim of this second edition
is to supplement and complement the first edition and other complementary
volumes on pharmaceutical analysis2–4 and to provide a comprehensive text of modern
pharmaceutical analysis that incorporates various relevant requirements and
new initiatives to address DP quality. The key features of the second edition are listed
below:
• Provides the latest analytical technology that allows greater sensitivity and
selectivity.
• Includes methods for monitoring GTIs.
• Highlights implications for pharmaceutical analysis based on the new paradigm,
“Quality by Design.”
• Covers characterization and analysis of biopharmaceutical proteins, as these
molecules are gaining significance.
• Provides up-to-date information on documentation in light of regulatory
guidance, technology, and industry trends.
This book has been designed to be particularly useful for both novice and
experienced method development chemists in the pharmaceutical industry who
are seeking to update their knowledge. It should continue to serve as a definitive
reference source on pharmaceutical analysis for researchers, analysts, managers,
and pharmaceutical industry regulators.

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