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Application Note

Reliably Quantify Genotoxic Impurities in Active Pharmaceutical Ingredients

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Application Note

Reliably Quantify Genotoxic Impurities in Active Pharmaceutical Ingredients

p-toluenesulfonic acid is frequently used in the drug 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.

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

Download this application note to find out why HPLC-UV is most suited to this, demonstrated by values including:

  • Limit of detection
  • Limit of quantitation
  • Recovery rate
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