LAUSR

Transmission Raman spectroscopy is a relatively new technique for quantitative analysis of pharmaceutical products, either during manufacturing or as a finished product test. As with any new analytical tool, several requirements need to be met for widespread application. These include assessment of technical capability, integration with quality and manufacturing processes and successful deployment in a quality-controlled environment. In the first paper of a two-part series, regulatory guidelines and method development were discussed for the creation of transmission Raman spectroscopic methods for content uniformity (CU), assay and drug product identity (ID) applications. In this part II, the practicalities of method development are addressed, and an example of the development of a quantitative method for the determination of drug content uniformity in individual tablet cores using partial least-squares is presented.