A new paper, from authors at five major pharmaceutical companies and Agilent Technologies (formerly Cobalt Light Systems), discusses transmission Raman spectroscopy (TRS) and the regulatory considerations for method development. This publication, the first of two related papers, discusses the considerations for regulatory submission. The second paper will present practical method development with examples for data analysis and method development processes.
Agilent's TRS100 system is used for quantitative analysis of pharmaceutical products, either during manufacturing or as a finished product test. TRS can augment the QC laboratory workflow, reduce testing and dead time by days or weeks, avoid consumables costs and reduce staff resource compared with wet chemistry.
The paper - Analytical Method Development Using Transmission Raman Spectroscopy for Pharmaceutical Assays and Compliance with Regulatory Guidelines—Part I: Transmission Raman Spectroscopy and Method Development - is available on the Journal of Pharmaceutical Innovation website.