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Medical Device Testing - Chemistry and Materials Characterization

NAMSA’s chemistry laboratories provide analytical support for the development and quality audit of medical devices, reagents, and excipients. Principle areas of work are instrumental analysis of polymers and other product components for purity, uniformity, composition, sterilant residues and general extractables so the material has identity and reproducibility in product manufacturing.


 
View our Chemistry & Materials Characterization Tests

We offer a comprehensive range of chemistry testing services to help ensure product safety, quality and consistency during all stages of development. Our technical specialists will work with you to design and implement special studies for medical devices and pharmaceutical container/closure systems.

Click here to receive a FREE Materials Characterization Matrix™

Chemical/Material Characterization
Test Procedures
  • Physio-Chemical Tests
  • FTIR Fourier-Transformed Infrared spectroscopy
  • HPLC-MS High Performance Liquid
    Chromatography Mass Spectrometry
  • HPLC-FTIR
  • GC-FID Gas Chromatography -
  • Flame Ionization Detector
  • GC-MS
  • ICP Inductively Coupled Plasma
  • Physical/Mechanical
  • Specific Gravity
  • Durometer Hardness
  • GPC Gel- Permeation Chromatography
  • Viscosity
  • SEM/XRD Scanning Electron Microscopy/
  • X-Ray Diffraction
  • DSC Differential Scanning Calorimetry
 

Other Capabilities
  • Analytical Method Development and Validation
  • ASTM Extractables
  • CFR Extractables for Food and Beverage contact
  • Container/Closure Leachables
  • EO/EC/EG Analysis
  • Heavy Metals, USP Methods 1& 2
  • International Pharmacopoeia (BP, EP, JP, USP)
  • Ion Content Analysis (Chloride, Fluoride)
  • Melting Point determination
  • Moisture Determination
  • Osmolarity
  • Particulate Testing & Analysis
  • Protein, Peptide and Amino Acids
  • Purified Water Testing
  • Rotational and Capillary Viscosity
  • Thermal Analysis
  • Trace Metals - AA and ICP
  • USP Plastics and Container Testing