Deformulation

Imaging plays an integral role in the deformulation of any product. Separation and quantification of individual ingredients often requires a suite of analytical instrumentation. The Phenom ProX desktop SEM with EDS is the ideal tool for accurately measuring pharmaceutical particle morphology, sizes and distribution and determining elemental composition of active pharmaceutical ingredients (API) and excipients.

Determination of Excipient Elemental Composition by EDS

Energy dispersive X-ray spectroscopy can be used to quantitatively determine the elemental composition of materials with extremely high spatial resolution. While EDS does not provide direct chemical information about the bonding of the identified elements, careful inspection of the image can often be employed in conjunction with the elemental information to determine the excipient utilized.


Single point EDS acquisitions acquired on the bulk tablet (top) and an identified excipient (bottom)

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30 seconds of EDS spectroscopy has identified all of the brighter particles within the tablet matrix to be excipients containing higher weight percentages of silicon and aluminum with respect to the bulk.

Back-scatter electron imaging can now be employed to quickly and quantitatively determine the area coverage of the excipient particles. Coverage likely corresponds to the ratio of excipient to API used during the formulation of the tablet prior to compounding.


Raw back-scatter and processed image. Total excipient coverage is 32%

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Applications

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