Analytical Method Development Using Transmission Raman Spectroscopy for Pharmaceutical Assays and Compliance with Regulatory Guidelines—Part I: Transmission Raman Spectroscopy and Method Development

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 things need to be accomplished for widespread application use—assessment of technical capability, fit with quality and manufacturing processes and successful deployment in a quality-controlled environment. The technical capability has been discussed previously, but the practicalities of method development and submission to regulatory authorities have not. In this, one of a series of two papers, the considerations for regulatory submission are discussed. In the second paper, practical method development will be presented and examples provided for data analysis and method development processes.