Ferric carboxymaltose characterization with synchrotron X-ray methods

This testing package combines several synchrotron-based X-ray techniques to characterize intravenous ferric carboxymaltose products in accordance with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance, which require the manufacturer to demonstrate that the tested product is of similar quality to an already approved reference product. Synchrotron measurements are used instead of conventional ones to ensure the necessary signal-to-noise ratio and resolution for highly disordered and/or nanoscale materials.

The following analyses are included:

• Determination of iron species' oxidation states (e.g., Fe3+), coordination geometry, electronic structure, and qualitative identification of the local chemical environment with XANES (X-ray absorption near edge structure).

• Quantitative local atomic structure, including neighbouring atom types, coordination numbers, bond distances, and structural disorder with EXAFS (extended X-ray absorption fine structure).

• Identification of the precise polymorphic form of the core (e.g., akaganeite-type FeOOH) and calculation of unit cell parameters and crystallite dimensions with HR-XRPD (high-resolution X-ray powder diffraction) & PDF (pair distribution function).

• Measurement of distinct length-scale regimes to distinguish the crystalline inner core size from the total particle dimensions, with possible sensitivity to the amorphous surface layer with SAXS (small-angle X-ray scattering) & PDF.

• Evaluation of the overall shape of nanoparticles with SAXS to confirm whether the scattering bodies are compact, elongated, or branched.

The results are compiled into a single test report that correlates findings across the different techniques and compares them with the expected reference parameters.