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Legal regulations demand that organic impurities in pharmaceuticals must be identified and characterized. The isolation of impurities from a pharmaceutical product can be done by preparative-scale liquid chromatography (LC). This Application Note demonstrates the purification of acetaminophen and six known impurities using an Agilent 1290 Infinity II Preparative LC/MSD System. For high throughput and sample load, a column of 50 mm inside diameter (id) is operated at a solvent flow of 118 mL/min. Mass-based fraction collection is combined with UV detection for highest selectivity. The performance of the fraction collection is assessed by determining the purity of collected fractions and the recovery of the active pharmaceutical ingredient (API).
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