We can undertake contamination and impurity analyses and identification of:

  • New / unknown peaks during drug assays
  • Discoloration / contamination of drug product or packaging
  • Unknown residues
  • Out of trend, out of specification

We employ a wide range of analytical techniques to get results: 

  • GC-MS
  • LC-MS
  • FT-IR

Application of the Techniques for Impurity Identification

Our comprehensive (multidimensional) gas chromatography capabilities can assist with the separation and identification of substances in complex mixtures, which would otherwise be masked using traditional chromatographic techniques.

Conventional GC-MS chromatogram for ‘sample X’

This shows two high concentration analytes (peaks A and B), which could potentially mask other compounds with corresponding retention times (due to having similar boiling points to peaks A or B).

Comprehensive GC-MS allows the simultaneous separation of analytes based on their boiling points and relative polarity. This allows detection, identification and quantification of compounds which would potentially be interfered with or hidden by other compounds present; especially if there is a wide range of different concentrations of analyte in the sample.


Find out how Smithers can help your organization with impurity identification. Contact us today for more information.

Show Policy

Latest Resources

See all resources