US FDA Purchases Transmission Raman for Quantitative Analysis of Tablets and Capsules

The United States Food and Drug Administration (FDA) has purchased Cobalt’s TRS100 transmission Raman instrument for use by the Division of Pharmaceutical Analysis (DPA). Transmission Raman spectroscopy (TRS) is an increasingly‐used alternative to conventional chemistry‐based analytical testing, such as High‐Performance Liquid Chromatography (HPLC). TRS takes seconds per tablet or capsule, does not require preparative steps and works with a wide variety of drug products.

Unlike other spectroscopic methods, method development for drug product analysis can be fast, using a small number of calibration samples. These features are beneficial for conventional quality control (QC) testing and also for high throughput screening, which is a featured requirement of the FDA’s procurement scope, detailed in the specification document RFQ‐FDA‐1159449:

“The DPA has successfully implemented spectroscopic screening technologies for use at import centers and mail facilities within the US. Increasingly, DPA is performing screening on finished products which have traditionally been tested using compendial methods. Existing methods for these samples have focused on laboratory testing that requires several sample and instrument preparation steps, a requirement which is both time consuming and expensive. Preliminary work performed by DPA has indicated that Raman spectroscopy, a technique that is both rapid and nondestructive, is a potential alternative for these methods. Moreover, Raman methods require little, if any, sample preparation and can be used by non‐technical users in the field. Further progress on development of quantitative Raman methods depends on new instrumentation which is able to test a high throughput of samples in an automated and repeatable fashion.”

Transmission Raman spectroscopy is a growing technique, used in quantitative analysis of active pharmaceutical ingredients and for low‐concentration polymorph analysis. The first regulatory approval was made in the UK in 2014 by Actavis as an alternative QC release test, replacing wetchemistry methods for content uniformity, assay and ID.

For a broad discussion on transmission Raman see Cobalt’s website. Uses in pharmaceutical analysis were discussed by GlaxoSmithKline, AstraZeneca, Bristol‐Myers Squib, Actavis and others at the world’s first transmission Raman seminar, held in Oxford in December 2015. Videos of the selected presentations are available on Cobalt’s website.