Pharmaceutics

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There are many areas within pharmaceutical research and production which can benefit from the elemental micro-analysis capabilities of XRF.

A key area is the analysis of tablet formulation processes – micro-XRF imaging allows inorganic materials within a tablet to be imaged over large areas, and with high spatial resolution. The penetrating nature of the x-rays even allows internal analysis, so that contaminants within the tablet can be visualised and identified. In addition to tablets, other typical pharmaceutical products can benefit from the imaging capabilities of the technique: cosmetic creams, toothpastes, ointments and powders.

The general analytical power of XRF is ideally suited to assist trouble shooting labs within the pharmaceutical industry. Examples of areas which are particularly well suited include sample homogeneity and mixing efficacy, contamination, and inter-batch concentration fluctuations.

The ability to pinpoint single microscopic particles and subsequently identify and/or characterise them is a an important requirement for particulate analysis. Ocular and IV formulations must meet stringent requirements for particulate concentrations, and micro-XRF is the ideal tool to analyse these particles. Process engineers can then quickly trace the particles to specific stages of the manufacturing process.

Key areas which benefit from micro-XRF include:

  • Tablet imaging (API distribution, mixing uniformity)
  • Contaminant identification
  • Raw material composition
  • QC/QA
  • Particulate analysis
  • Trouble shooting

Example

Mapping across a tablet surface allows a buried steel particle to be visualised and identified. Contaminants such as this can be introduced from the tablet manufacturing process, and are typically caused by wear debris from the mechanical mixing/compressing entering the tablet materials.