Raman spectroscopy has become established in many pharmaceutical research and analytical laboratories. Applications benefiting from Raman are plentiful, and extend from screening in early phase Discovery to final product testing in Manufacturing. Due to the high-information content contained in the Raman spectrum, chemical and in some cases physical information regarding the material under investigation can be obtained.
This information can be critical to the goals of product quality and manufacturing robustness by generating process understanding. The US Food and Drug Administration (FDA) recent initiative in Process Analytical Technology (PAT) and Quality by Design (QbD) manufacturing encourages the application of tools and methodologies to ensure product quality within the pharmaceutical industry by providing a framework for quality by design.
- Screening of New Drug Entities Using High Throughput Screening (HTS) Techniques
- Polymorphic Form ID
- Real-time Reaction Analysis and Optimization
- End-point and Intermediate Detection
- Hydrate / Solvate, Salt Detection and ID
Drug Product Applications Include:
- Raw Material Identification on the Dock, at the Dispensary, and at the Hopper
- Real-time Monitoring of Granulation, Blending, Drying, and Coating
- Non-destructive Tablets, Gel-caps, and Liquid Formulation Analysis
Further information on pharmaceutical Raman applications can be found in Handbook of Raman Spectroscopy: From Laboratory to Process Line by Ian R. Lewis and Howell G. M. Edwards, Marcel Dekker, New York, New York (2001) and Pharmaceutical Applications of Raman Spectroscopy by Sobodan Sasic, John Wiley and Sons, Hoboken, New Jersey (2008)
Additional articles outlining the utility of Raman for pharmaceutical analysis and manufacturing can be found at the American Pharmaceutical Review website. www.americanpharmaceuticalreview.com