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Coupling Mass Detection with UV to Improve Method Sensitivity
for Esters of Benzenesulfonic Acid in Analysis of Genotoxic Impurities

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Overview

Managing Your Labs' Data

Genotoxic impurities (GTIs) are intermediates or reactants that can develop during the synthesis of a drug substance. In addition to process impurities, certain drugs may generate GTIs via degradation during formulation or storage. The genotoxic compounds have the potential to react with DNA, which could consequently cause a carcinogenic response and tumor development. It is therefore essential to identify the presence of these impurities early in the drug development process, and to have reliable and highly sensitive methods for their accurate determination in both drug substance and drug product.

Key Learning Objectives

  • Develop a robust and quick UPLC method to detect genotoxic substances in drug formulations or during storage
  • Learn to analyze samples for methyl, ethyl, and isopropyl esters of benzenesulfonic acid
  • Understand how an ACQUITY QDA Detector can enhance sensitivity and selectivity for genotoxic impurity monitoring
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