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Batch Characterization of Polysorbates

A universal-detection method for pharmaceutical manufacturing operations uses reverse-phase HPLC with the Corona CAD detector for sensitive and robust analysis of polysorbates. It is suited for speciation of the various individual components of a non-ionic mixture and for batch-to-batch comparisons to measure variations in polysorbate composition from various sources or lots of material. The Corona CAD system features low nanogram sensitivity, a dynamic range exceeding four orders of magnitude, and good precision response factors that are independent of structure and no/low analyte level response drop-off. The robust, plug-and-play device requires no calibration or optimization. It delivers orders-of-magnitude advantages in sensitivity, dynamic range, consistency, reproducibility and ease of use, providing universal HPLC detection of virtually any non-volatile or semi-volatile compound, including proteins, lipids, carbohydrates and small molecules.
ESA Biosciences Inc.
22 Alpha Road
Chelmsford, MA, 01824-4171