Release and Stability Testing

Xcelience offers a complete stability program with ICH, cGMP, and global storage conditions. We provide our clients full access to a broad range of technologies for in-process and release testing, final drug product release testing, and stability evaluations to support your drug product development programs.

Xcelience’s analytical capabilities for in-process evaluations, drug product release and stability include:

  • ID testing
  • HPLC, UPLC for assay, related substance evaluations
  • In-vitro evaluation (dissolution)
  • Moisture (Karl Fischer, volumetric, coulometric)
  • Chiral determination
  • Cleaning verification method development and analysis
  • Drug product stability reports (SLIM®)

 

Xcelience has the capability to store stability samples at a variety of temperature and humidity conditions that meet the standards of the International Conference of Harmonization (ICH), including:

  • 2 – 8°C
  • 25°C /60% RH
  • 30°C /65% RH
  • 30°C /75% RH
  • 40°C /75% RH