Impurity Isolation

Averica Discovery Services, Inc.

Averica Discovery’s Targeted Isolation™ process rapidly develops a unique isolation strategy for each impurity.  A frequent goal is to isolate a quantity of each impurity for impurity profiling and structure elucidation.  The critical information gained speeds candidate development from IND-enabling studies to NDA.

Averica’s impurity isolation and characterization begins with an exchange of data, knowledge, and methods so that a project can move quickly to isolation work.  Averica’s scientists develop methods to enrich and finally purify each peak of interest, rotating between preparative chromatography and analysis and isolation in a pattern uniquely designed for each target peak.  Isolation of milligrams of pure compound – even when dealing with a 0.01% impurity – is often possible.

Averica’s Targeted Isolation™ has been a remarkably successful program supporting both drug substance and drug product development.  Whether solving problems during clinical development, completing CMC filings, or improving GMP synthesis, Averica’s impurity isolation is a proven strategy for reducing development cost and time.



  • Isolate needed trace impurities from mixtures for structure work or assay
  • Determine structures of unknown substances
  • Isolate impurities from drug substance or drug product
  • Scale up to isolate reference standard supply
  • Access difficult to isolate impurities

The Averica Advantage

  • A unique Targeted Isolation™ strategy developed for each impurity
  • Work fast, with less, and solve problems during GMP process development
  • Simplified project budgeting with no unpredictable cost overruns