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