Core Capabilities 

• Drug substance and drug product stability indicating assays

• Related substances, chiral purity, elemental impurity, and residual solvent analysis

• Dissolution testing with UV and HPLC backend

• Preservative and stabilizing excipients assays

• Phospholipid and fatty acid analysis

• Physical and structural chemistry

• Remedial method validation/method lifecycle evaluation studies

• Drug substance and reference standard material characterization

• Reference standard qualification

• Process validation support

• Cleaning method verification

• Drug product comparator studies

• Material contact studies

• In-use and administration set compatibility studies

• Extractables and leachables studies

• Solid state characterization