Extraction and Leachables

Extraction and Leachables

Legend Technical Services, Inc offers medical device manufacturing support that complies with FDA and EPA Good Laboratory Practices (GLP). Analytical testing is done at the St. Paul laboratory where our experienced medical device consultants and analysts manage routine quality control analyses as well as customized developmental and validation study procedures. Comprehensive calibration, verification, and validation assure the highest confidence in results to support R&D while being economically affordable. Contact us to discuss your medical device needs at 651-221-4060.

SERVICES

  • Extraction/Leachables Studies ISO – 10993 – Parts 13, 15, 18
  • ISO 18562
  • Infusion Equipment  ISO – 8536 Parts 4, 8, 9
  • Chemical Stability Studies
  • Investigative Problem Solving
  • Failure Analysis
  • Polymer Analyses
  • USP Analysis
  • ASTM Testing Protocols
  • Melting Point/Glass Transition Measurements
  • Water Purity Testing
  • Substitute Vendor/Materials Qualifications
  • Thermal Analyses – DSC, TGA

To learn more about ISO 10993 and ISO 18562 testing requirements, visit the U.S Food & Drug Administration website.

INSTRUMENTATION

  • Waters Acquity UPLC with Xevo Triple Quad Mass Spectrometer (LC/MS/MS)
  • Waters Acquity UPLC with Xevo G2-S Time of Flight (TOF) Mass Spectrometer
  • Gas Chromatography (ECD, FID, TCD, NPD, PID)
  • Gas Chromatography/Mass Spectrometry (GC/MS)
  • GC/MS High Resolution Accurate Mass Thermo Orbitrap
  • High Performance Liquid Chromatography (HPLC/UV/RI)
  • Ion Chromatography (IC)
  • Gel Permeation Chromatography (GPC)
  • Digital Microscopy
  • Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES)
  • Inductively Coupled Plasma-Mass Spectrometry (ICP-MS)
  • Fourier Transform Infrared Spectroscopy (FTIR)
  • Microscopic FTIR
  • UV-Visible Spectrometry (UV-VIS)
  • Automated Titrations
  • Thermal Gravimetric Analysis (TGA)
  • Differential Scanning Calorimeter (DSC)

Have more questions?

Whether you have questions about our services, need assistance, or have regulatory concerns, we can help.
Contact any of our locations.