Impurity Identification

Impurity identification is a critical part of your quality control process. Unexpected challenges can occur with impurity characterization due to the complexity and diversity of potential impurities that may arise in your process that need to be identified and quantified. Meeting these challenges and the associated regulatory requirements may necessitate multiple analytical techniques requiring expertise in preparative-scale chromatography, impurity isolation, nuclear magnetic resonance (NMR) spectroscopy and analytical-scale chromatography with mass spectrometry (MS). In addition, impurity isolation can be daunting and require selective and sensitive analytical methods if the impurities are present at low levels or are unstable once isolated.

At Cambrex, we have extensive experience and a proven track record of identifying, isolating, and characterizing impurities. Our preparative equipment includes normal and reverse-phase high-performance liquid chromatography (HPLC) to enable the isolation of materials. Our specialists are skilled at impurity characterization using MS, preparative and semi-preparative chromatography, and NMR spectroscopy.

The most difficult structure elucidation challenges require an integrated approach that combines advanced analytical techniques, and our team of scientists will work closely with you to determine an impurity isolation, characterization and identification strategy that delivers rapid results and mitigates your risk. With open communication and a collaborative style, we’re the experts you’ll enjoy working with.


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Looking for a partner that balances passion with meticulous attention to detail. Speak to one of our experts about how we can help with your impurity characterization needs.

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