Whitepaper: Raman-Based Endpoint Detection of a Heterogeneous Etherification Reaction

Raman spectroscopy has been successfully integrated in laboratory, pilot, process development and GMP manufacturing environments. Find out how it was used at the pilot scale to detect the endpoint of a heterogeneous etherification reaction…

Regulatory guidelines, from the 2004 U.S. FDA PAT framework to ICH Q8, Q9, Q10 and Q11 documents, have brought a shift to pharmaceutical processes and manufacturing. The PAT and QbD approach described in these and other regulatory documents provides strategic guidance for a more thorough understanding of risks in pharmaceutical manufacturing and how those risks affect a product’s critical quality attributes.

Raman spectroscopy is a valuable PAT in pharmaceutical manufacturing. In this whitepaper, Raman spectroscopy accurately determined the endpoint of a heterogeneous reaction used in primary API manufacturing. Use of Raman in feedback/feed-forward control protocol is feasible, enabling automated process control process from remote sites.