News & events Insight & resources Facilities Careers Contact Drug substance Drug product Analytical services Open Search Suraj Shrestha, PhD Scientist II Analytical Services Analytical solutions Quality assured Find out more about our services below Impurity isolation, identification & characterization Impurity Isolation 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. Further information For more information about our processes or analytical services in general, get in touch with our team. Contact Us Analytical services Speak to one of our experts About us Cambrex provides drug substance, drug product and analytical services across the entire drug lifecycle Quality & regulatory We deliver quality in every aspect of our work, across all of our facilities, systems and teams Environment, health & safety Our strong commitment to the environment and health and safety underpins all that we do at Cambrex Cambrex careers At Cambrex, it’s our people that set us apart. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts that enjoy what they do Contact About Recruitment policy Privacy Sitemap Forms & Certificates Manage Cookies © 2007-2021 Cambrex Corporation. All rights reserved. This site uses cookies to store information on your computer. Some of these cookies are essential, while others help us to improve your experience by providing insights into how the site is being used. AcceptDecline Necessary Cookies Necessary cookies enable core functionality such as page navigation and access to secure areas. The website cannot function properly without these cookies, and can only be disabled by changing your browser preferences. Analytical Cookies Analytical cookies help us to improve our website by collecting and reporting information on its usage. Analytical Cookies On Off Marketing Cookies We use marketing cookies to help us improve the relevancy of advertising campaigns you receive. Marketing Cookies On Off Save and close