Isolation of impurities may be required for a variety of reasons, such as structure elucidation, generation of materials for use as reference standards and separation of racemic mixtures into enantiomers.
Cambrex has preparative equipment with multiple modes of separation, including normal and reverse phase High Performance Liquid Chromatography (HPLC), to enable isolation of materials as necessary. Cambrex has many years of experience with these techniques to enable effective isolation in the most efficient possible manner.
Impurity Identification and Characterization
Structurally characterizing small amounts of material is a key step in solving many challenging hurdles encountered during pharmaceutical development and manufacturing.
Materials of interest include:
Reaction side products produced during process development and scale up; impurities formed during stability studies via API degradation or reaction with excipients; metabolites of APIs observed during clinical testing.
At Cambrex we have extensive experience tackling these issues and a proven track record of identifying, isolating and characterizing these materials. Areas of expertise and capabilities include mass spectrometry (MS), preparative and semi-preparative chromatography, and nuclear magnetic resonance (NMR) spectroscopy. The most difficult structure elucidation challenges require an integrated approach that utilizes advanced analytical techniques in concert. Cambrex excels at tackling such problems efficiently and providing concise professional reports suitable for inclusion in regulatory filings.
For more information about our processes or analytical services in general, get in touch with our team.