Process related impurities are a major issue that have to be avoided in order to protect patient health.  RSSL’s expertise in isolating and identifying impurities, plays a critical role in helping our customers to develop and manufacture pharmaceutical products. 

Our expertise in chromatographic and spectroscopic techniques can be applied to 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.  

Impurity Isolation Services

Techniques

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) 

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