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Poster Describes How to Measure Nanograms of Impurities

A new technical poster describes how a Corona Charged Aerosol Detector (CAD) enables the routine measurement of low-nanogram levels of organic impurities in active pharmaceutical ingredients (APIs). The measurement of the level of organic impurities in an API is critical to the development and manufacturing process. The level of organic impurities—which may include unreacted starting materials, by-products, intermediates, degradation products and reagents—is tightly controlled and heavily regulated to ensure patient safety. Many of the impurities present in pharmaceutical preparations are difficult to measure with traditional technologies because they have a poor UV signal or may lack any chromophore at all. The Corona CAD system offers advantages, including low-nanogram sensitivity, a dynamic range exceeding four orders of magnitude, good precision response factors that are independent of structure, and no/low analyte level response "drop-off." The complement to UV detection, the detector provides HPLC detection of non-volatile and many semi-volatile compounds.
ESA Biosciences Inc.
22 Alpha Road
Chelmsford MA 01824-4171
Phone: 978-250-7000
Fax: 978-250-7090
http://www.esainc.com

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