Analytical Method Development Using Transmission Raman Spectroscopy for Pharmaceutical Assays and Compliance with Regulatory Guidelines—Part II: Practical Implementation Considerations

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...