Nuclear magnetic resonance spectroscopy in pharmaceutical analysis

NMR is still the premier method for structure determination of small molecules. This is the primary use of NMR spectroscopy in pharmaceutical development. The structures of both the drug candidate and its impurities will be subject to great scrutiny as the drug moves through development. The section on structure elucidation, which includes a discussion of the uses of multinuclear NMR, will deal with this area specifically. [Pg.105]

The increasing need for identification of low-level (0.1%) impurities has lead to the development of specific methods for microgram amounts of analyte and for mixture analysis, and now key among these methods is the hyphenation of NMR to separation techniques such as high performance liquid chromatography (HPLC). LC/NMR is now such a widespread technique that a separate section is devoted to this topic. [Pg.105]

There are also an increasing numbers of analyses that make use of NMR quantitative, either for limit tests, quantitation of impurities or for assays of components in dmg substance or dmg product. Section 4.4 discusses the requirements for quantitative NMR and the practical aspects, including validation of NMR methods. [Pg.105]

Finally, Section 4.5 deals with the principles of solid state NMR and an indication of the future prospects in this technique, which is gaining widespread acceptance as an important method in the characterising of solid state form and the understanding of stmcture in the solid state. [Pg.105]

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