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APP NOTE

Reliably Quantify Genotoxic Impurities in Active Pharmaceutical Ingredients 

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p-toluenesulfonic acid is frequently used in the manufacturing process as a counterion to salt formation. p-toluenesulfonates may be formed when the acid reacts with methanol, ethanol, or propanol used in the reaction pathway. 

As these compounds are carcinogenic; therefore, they need to be accurately monitored and quantified during both the process and in the final control of the drug substance.

Download this application note to discover why HPLC-UV is the preferred analytical method and how it can be used to provide:

  • Very sensitive determination of genotoxic p-toluenesulfonate impurities
  • Accurate quantitation over a wide concentration range
  • High recovery rates