Legend — Analytical Chemistry
Legend specializes in supporting the unique analytical chemistry and physical testing needs associated with medical device manufacturing and product development. 

Experienced chemists manage customized study protocols to support FDA submissions as well as routine quality control analyses.

Comprehensive calibration, verification and validation (ISO 9001-2008 and ISO 17025 accredited) assure the highest confidence in results to support R&D and regulatory compliance. In doing so, LEGEND complies with FDA, GLP and cGMP guidelines.

Services

  • Extraction Studies ISO – 10993
  • Parts 13, 15, 18
  • Infusion Equipment  ISO – 8536
  • Parts 4, 8, 9
  • Chemical Stability Studies
  • Investigative Problem Solving
  • Failure Analysis
  • Polymer Analyses
  • Thermal Analyses – DSC, TGA, TMA, DMA
  • Particulate Analysis
  • USP Analysis

 

  • ASTM Testing Protocols
  • Melting Point/Glass Transition Measurements
  • Water Purity Testing
  • Substitute Vendor/Materials Qualifications
  • Analytical Instrumental Capabilities; GC/MS, GC/FID/TCD, HPLC/PDA/RI, UPLC/PDA, UPLC/MS/MS, GPC, ICP-OES, ICP-MS, DSC,
  • ICP-LC-MS, IC, TGA, DMA, Uv-Vis, FTIR