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Impurity profiling

Impurity expertise redefined

Impurity identification and structural elucidation represent frequent and often challenging tasks in process development. Nuvisan scientists are experienced in isolating and characterising unknown impurities from drug substance, drug products and leachables. 

A small vial with blue liquid in it is placed on a spectra paper showing chemical structure of a molecule

Impurity identification

By combining high-resolution mass spectroscopy (HRMS) and nuclear magnetic resonance (NMR) techniques, Nuvisan scientists can gain access to an impurity structure in a very efficient manner. We have solved hundreds of impurity challenges thanks to our extensive chemical understanding and use of state-of-the-art equipment.

 Impurity isolation

Using micropreparative techniques or preparative high-performance liquid chromatography (prep-HPLC), as well as preparative supercritical fluid chromatography (SFC), Nuvisan can offer a wide range of isolation techniques to collect impurities even at low levels (<0.1%). This enables us to provide efficient and cost-effective solutions to quickly navigate through the regulatory landscape and offer our clients support in defining a controlled strategy. 

 Impurity synthesis

Once an impurity structure is identified, Nuvisan can synthesise the targeted impurity, from mg to hundreds of grams, and measure response factors to help ensure an accurate calculation of the impurity content. This service allows us to generate impurity markers to support controlled strategy and analytical activities, including nitrosamines.  

 
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