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Practical Application of Supercritical Fluid Chromatography for Pharmaceutical Research and Development provides a valuable “go-to” reference for many difficult-to-solve challenges using pertinent chromatographic theory, first-hand case studies, and examples provided from academic and industry experts. This text also enables professors teaching an analytical instrumental course to introduce and instruct students about one of the most sustainable and powerful separation methods currently available. While the text has broad applicability across industrial sectors, it focuses primarily on application in the pharmaceutical industry. The book is designed to allow readers to align current HPLC/UHPLC capabilities with SFC as an orthogonal tool for project specific methods in the pharmaceutical industry. It highlights where SFC falls on the spectrum of useful chromatographic tools for routine and challenging separative methods.
Experienced HPLC users who are interested in developing knowledge in orthogonal separation techniques, as well as newcomers to the field of separation science, will find this text particularly useful. Chapters address where SFC may fit the analytical needs of the pharmaceutical industry and alert the readers as to where the technique will not fit. Readers will gain an understanding of how and where SFC may be applied and adapted more routinely across the pharmaceutical industry as a ‘green’ way of undertaking separation opportunities and challenges. Areas within the pharmaceutical industry include early drug discovery, process chemistry, and late stage development and manufacturing.
Describes approaches to SFC column and mobile phase selection for method development for both analytical and preparative tasks.
Gives practical examples of how analytical SFC enables the monitoring of synthetic reactions including unstable intermediates, chiral and achiral polar reactants and products across small and large modalities.
Provides need-focused case studies for pharmaceutical analysts, process chemists, and contract chemistry facilities that can benefit from monitoring or purifying polar intermediates, mutagenic impurities, nitrosamines and other reaction by-products including excipients and metabolites.
Evolution of packed column SFC as a greener analytical tool for pharmaceutical analysis
Application space for SFC in pharmaceutical drug discovery and development
Selection of SFC stationary and mobile phases
Measurements of drugs and metabolites in biological matrices using SFC and SFE-SFC-MS
Synthetic chemistry screening for robust analysis and purification from discovery through to development
Application of preparative SFC in the pharmaceutical industry
Method development approaches for small-molecule analytes
Application of SFC for the characterization of formulated drug products
Expanding the boundaries of SFC: Analysis of biomolecules
Different detectors used with SFC
SFC in GMP testing and quality control of medicinal drug products
Best practices and instrumental troubleshooting for successful SFC methods
The state-of-the-art and future perspectives for SFC