Unknown impurities can arise in both API and drug products across all stages of the R&D life-cycle starting at the discovery stage and spanning all the way through to commercialisation.These impurities have to be avoided in order to ensure patient safety. 

RSSL’s expertise in isolating and identifying impurities plays a critical role in helping our customers to research, develop and manufacture high quality pharmaceutical products. 

Preparative scale isolation is carried out using techniques including (but not limited to) preparative liquid chromatography and post purification treatment such as freeze drying.

Advanced spectroscopic techniques can then be employed to identify the impurities of interest, including 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 purification methods for your products and API’s.  

Impurity Isolation Services


Techniques

Analytical Scale Chromatography - Reverse Phase, Ion Exchange and Normal Phase

Preparative High Performance Liquid Chromatography (HPLC)

Rotary Evaporation and Freeze Drying

Liquid Chromatography Mass Spectrometry (LC-MS) – with triple quadrupole, Time-of-Flight (ToF) and Orbitrap

Nuclear Magnetic Resonance Spectroscopy (NMR)

Fourier Transform Infra-Red Spectroscopy (FTIR)

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