ABSTRACT
The mission of any ethical pharmaceutical company and the charter of every regulatory agency worldwide is to provide safe and effective drugs to the marketplace. Analytical methods play a vital role in supporting every facet of the drug development and approval process, from discovery through for-mulation, process development, manufacturing, packaging, and ultimately the release of both active pharmaceutical ingredients (APIs) and finished drug products. This importance has been recognized in the United States by the Food and Drug Administration (FDA), which has published gui-dances concerning analytical methods [1, 2], and internationally, with the International Conference on Harmonisation (ICH) devoting an entire “quality topic” to analytical methods [3, 4].
