There is a large variety of Infrared- and Raman-spectroscopic applications in the pharmaceutical industry. To meet the regulations in the pharmaceutical industry Bruker Optics provides validated 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.
Typical applications for the FTIR 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 FTIR microscopy (LUMOS).
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 FTIR imaging (HYPERION 3000) the distribution of the API and the excipients in tablets and lyophilizates can be measured.
FT-Raman spectroscopy in combination with a high throughput screening accessory is the ideal tool for automated measurements of polymorphs or other pharmaceutical products. Due to the availability of powerful and intuitive software packages a rapid processing of even huge amounts of spectroscopic data is possible nowadays easily and quickly.
In a QC laboratory environment, a system such as the MPA can be used along with our user-friendly OPUS/LAB software, which not only performs the measurement but also automatically performs the analysis of unknown samples. In addition, this software allows an identity test to be combined with a quantitative analysis such as moisture content or purity
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