Structural Elucidation

Structural Determination/Impurity Identification

Structurally characterizing small amounts of material is a key step in solving many challenging hurdles encountered during pharmaceutical development in the laboratory and manufacturing.

 

Materials of interest include:

  • reaction side products produced during process development and scale up
  • impurities formed during stability studies via API degradation or reaction with excipients
  • metabolites of APIs observed during clinical testing

 

The team at Avista Pharma Solutions has experience tackling all of these issues and a proven track record of identifying, isolating and characterizing these materials. Areas of expertise and capabilities include preparative and semi-preparative chromatography, mass spectrometry (MS) and nuclear magnetic resonance (NMR) spectroscopy.  The most difficult structure elucidation challenges require an integrated approach that utilizes these advanced analytical testing techniques in concert. Avista Pharma’s integrated team excels at tackling such problems efficiently and providing concise professional reports suitable for inclusion in regulatory filings.