Microanalysis in the Pharmaceutical Development and Quality Control

There is a large variety of Infrared- and Raman-spectroscopic applications in the pharmaceutical industry. For the analysis of small samples FT-IR and/or Raman microscopes are used.

Typical applications for the FT-IR microscopy are the analysis of particles and defects. Often the chemical identity of a particle that was found in a liquid or powdery drug during quality control (QC) has to be determined. In this case typically it should be clarified from which part of the product or the packaging the particle originates or if it is caused by a contamination and where its source is located.

Also defects of the packaging or abnormalities in the different dosage forms of the pharmaceuticals are analyzed using FT-IR microscopy (LUMOS II).

Coatings on various surfaces of diagnostics are analyzed by IR and/or Raman microscopes. Furthermore deposits on stoppers, syringes, hollow needles or packaging material are typical samples for this technique. To measure deposits on the inner surface of glass vials or even to perform a depth profiling of multilayer materials, compact Raman microscopes (SENTERRA II) are used.

Another typical application of the Raman microscopy is the investigation of polymorphism of the active pharmaceutical ingredient (API) in solid dosage forms. Using FT-IR imaging (HYPERION 3000) the distribution of the API and the excipients in tablets and lyophilizates can be measured.

To meet the regulations in the pharmaceutical industry Bruker Optics provides validated microscope systems that can be used according to GMP/GLP/cGMP-standards and that are controlled by software that fulfills the 21 CFR Part 11 regulations of the FDA.