Update: 30 September, 2023
This Application Note illustrates the possibilities of the Agilent 1290 Infinity LC system and the Agilent 6460A Triple Quadrupole Mass Spectrometer for quantitative analysis of poten- tial genotoxic impurities (PGIs) in active pharmaceutical ingredients (APIs). A generic approach was used to determine arylamine and aminopyridine PGIs in selected APIs. The influence of column length and mobile phase composition on the recovery of these impuri- ties in real samples were investigated. High resolution UHPLC using a 150 mm RRHD col- umn packed with 1.8 µm particles resulted in the best overall performance. In cases of good separation between API and the target solutes, analysis speed and sample throughput could be increased using a 50 mm RRHD column. Detection limits were below 20 ppb (ng/g, relative to the API) using MS/MS and below 100 ppb (ng/g, relative to the API) with DAD for 2,6-dichloroaniline, which could not be detected with ESI-MS at trace levels.
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Publication date: 12 June, 2012
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