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现代药物分析第二版
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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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