Impurity Isolation and Sample Purification
Identification, isolation and purification of process related impurities can be critical to the development and manufacture of pharmaceutical products. Our technical specialist’s expertise in chromatographic and spectroscopic techniques can support with the isolation and identification of impurities from pharmaceutical products or active pharmaceutical ingredients (APIs).
Preparative scale isolation is carried out using techniques including but not limited to preparative liquid chromatography (HPLC and ÄKTA), freeze drying and solid phase extraction. Advanced spectroscopic techniques can then be used to identify the impurities of interest, these include nuclear magnetic resonance spectroscopy (NMR), mass spectrometry (MS) and Fourier transform infra-red spectroscopy (FTIR). Once the impurity has been identified, we can also offer further scale-up for the isolation of larger quantities of impurities for use as reference materials.
We are able to scale-up customer specific methods or develop reproducible extraction and purification methods for your products and API’s.
- Low Pressure Liquid Chromatography with ÄKTApurifier
- Preparative High Performance Liquid Chromatography (HPLC)
- Chromatography Matrices - Reverse Phase, Ion Exchange and Normal Phase
- Liquid Chromatography Mass Spectrometry (LC-MS)
- Solid Phase Extraction (SPE)
- Freeze Drying
- Fourier Transform Infra-Red Spectroscopy (FTIR)
- Nuclear Magnetic Resonance Spectroscopy (NMR)
- Ultra-violet/Vis Spectroscopy (UV/Vis)