Analysis of Potential Genotoxic Impurities in Active Pharmaceutical Ingredients

Methanesulfonic acid (mesylate), benzenesulfonic acid (besilate), and p-toluenesulfonic acid (tosylate), chemicals used in the process of synthesizing active pharmaceutical ingredients, are likely to generate sulfonic acid ester (Fig. 1) as a reaction byproduct. These compounds are known as potential genotoxic impurities (PGI) and are a significant cause for concern among pharmaceutical manufacturers. This article introduces the analysis of sulfonic acid esters utilizing the GCMS-QP2010 Ultra.

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Mass Spectrometry, Gas Chromatograph-Mass Spectrometry
Potential Genotoxic Impurities, Pharmaceutical, Life Science, Drug discovery, DMPK, ADME, Safety testing, GCMS-QP2010 Ultra
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