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Colin Dye Expo Technologies LLC


Addressing the analytical challenge of low dose formulations


In the pharmaceutical analytical laboratory the high sensitivity of fluorescence spectroscopy for solution analysis is understood, although the measurement of fluorescence from solids, semi solids, powders and mixtures of pharmaceutical components is relatively uncommon particularly when compared to the use of NIR techniques. A significant proportion of the molecules used in the pharmaceutical industry, including biological and biopharma materials, exhibit fluorescence. Many excipient compounds show little or no fluorescence. It therefore seems surprising that process engineers and analysts have not shown more interest in fluorescence spectroscopy for such applications as blend monitoring and content uniformity or even reaction monitoring. Could it be with new instrumentation targeted at solid materials and the process monitoring challenge of the ever more prevalent low dose formulations that the situation is about to change?


The latest spectrometer to be released by


instrument manufacturer Expo Technologies LLC is the ePAT801, a fluorescence spectrometer


wavelength excitation and emission detection by manually preselected filters) by using multiple LEDs, individually switchable through the NovaPAC© control software, to provide the excitation, whilst the spectrometer records a wide range uv/visible spectrum. The full spectrum detection enhances specificity and offers the potential of real time monitoring of multi- component mixtures. As a complete PAT solution provider, Expo


Fluorescence spectra from powder mixtures of Caffeine/Lactose. (0% to 3% caffeine) suggesting a simple univariate caffeine calibration with no interference from the excipient.


complimenting the established NIR range and extending sensitivity limits beyond NIR by several orders of magnitude. The ePAT801 addresses the limitations of early and now obsolete process fluorescence instruments (single


also needed to address the practical requirements of routine system suitability checks. Expo worked with validation standards partner Avian Technologies to develop appropriate fluorescence standards and has added automated validation routines to NovaPAC© control software for ease of implementation.


Further details are available from Expo Technologies LLC.


Expo Technologies LLC Spectroscopy Engineering Software Process Spectroscopy by Expo


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ePAT601 The spectrometer standard for NIR blend monitoring. External “hot swap” batteries and on board PC.


ePAT602 An extended range NIR diode array with fast acquisition rates for blending and content uniformity.


ePAT611 Probe based NIR system using clean window technology for wet granulation and multiplex option for continuous process applications.


ePAT771 UV/Vis spectroscopy with ATEX certification for reaction monioring and cleaning verification.


ePAT801 Light Induced Fluorescence for extreme sensitivity. Non invasive and probe options, with batteries, data buffer and wifi, for use in all content uniformity operations.


content uniformity operation www.expoforpat.com


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