As the US Pharmacopeial Convention (USP) announces new elemental impurity limits (Chapter 232) and revised procedures relating to the analysis of pharmaceutical products, PANalytical is bringing its experience to bear on this important application. The Epsilon 5 EDXRF spectrometer is a unique solution that provides easy sample prep, rapid sample throughput and is capable of the required detection limits that are important for the analysis of starting materials, intermediates and finished products. In addition Epsilon 5 delivers the very high throughput needed to take full advantage of the technique on a day to day basis.
Ian Campbell, Sector and Product Marketing Manager XRF, explains how the Epsilon 5 fits into the new regulatory framework: “XRF has been broadly accepted in Asia and Europe for pharmaceutical research, and been a ‘permitted technique’ in the European Pharmacopoeia for some time. Only now is it being enabled in the USP, a move that brings immediate benefits to the industry, where answers in minutes using a single technique rather than hours, or even days, when using other techniques, are important.”
The Epsilon 5 is a fully integrated EDXRF analyzer consisting of a spectrometer, X-Y sample handler and industry tailored software. It offers a unique combination of advantages, including: a significantly reduced laboratory waste stream compared to standard chemical analysis, unattended and fully automated operation, extremely low background noise with low detection limits, and highly robust calibrations and data treatment algorithms. The result is the ideal XRF solution across a wide range of critical applications.