Method Development

The analytical testing methods used to monitor the synthesis and release of drug substances and drug products are your primary view into the quality of your materials. Avista Pharma focuses on efficiently developing phase-appropriate, high-quality analytical methods that guarantee the quality of your products.

 

We have extensive experience developing and validating:

  • HPLC/UPLC methods for assay and related substances utilizing a wide range of detection modes including UV, charged aerosol detection (CAD), refractive index (RI), evaporative light scattering (ELSD), mass spectrometry (MS) and others
  • Chiral HPLC methods for enantiomer resolution
  • GC-FID methods for residual solvents
  • GC MS methods for potential genotoxic impurities (PGI’s)

 

We routinely develop methods to support:

  • cGMP Raw Material testing
  • API Release testing
  • Reference Standard Qualification
  • Final Product Release testing
  • ICH Stability Programs

See what success looks like: Method Development—API and Method Optimization—API case studies