Chemical Characterization

  • What is Chemical Characterization?

    Chemical characterization is the process of defining the chemical properties of one or more components of a substance or device material. Characterization techniques are used for a variety of reasons such as identifying device materials, detecting the presence of impurities and degradants, or creating a chemical profile of an unknown formulation. Characterization can also be a valuable first step before performing a more intensive impurity identification study by eliminating some variables from the investigation.

  • Chemical Characterization
Chemical Characterization at EKG Labs

EKG Labs provides characterization services for a variety of materials and products. We have helped companies tackle analytical challenges for both medical devices and pharmaceutical products. We perform medical device characterization in accordance with ISO 10993 guidance for the delivery apparatus and other components of interest. Additional characterization capabilities include determining the presence of a new contaminant in a product and characterizing new drug formulations in preparation for validating an analytical method. We have experience characterizing a variety of materials including:

  • Drug Substances
  • Drug Products
  • Medical Devices
  • Excipients
  • Residual Solvents
  • Polymers
  • Metals
  • Ceramics
  • Composites
  • Packaging
  • Novel Materials

Chemical Characterization Techniques at EKG Labs

Isolation:
  • Liquid/liquid or solid phase extractions
  • Preparatory TLC
  • Preparatory HPLC
  • Flash Chromatography
  • Semi-preparatory Liquid Chromatography
Purification:
  • Preparatory Chromatography
  • Recrystallization
  • Solid Phase Extraction (SPE)
  • Semi-preparatory HPLC
Structural Elucidation:
  • NMR (1H and 13C)
  • FTIR
  • MS and MS/MS
  • Elemental Analysis (CHNSO)
  • High Resolution LC/MS/MS
  • High Resolution GC/MS
Purity Characterization:
  • Assay (UV, HPLC, GC, CE, and IC)
  • Chromatographic Purity (TLC, CE, GPC/SEC, HPLC, and GLC)
  • Metallurgical Catalysts (ICP, ICP-MS, AA, AE)
  • Inorganic Ash (ROI, ICP, ICP-MS, AA)
  • Residual Solvents (Headspace GC)
  • Moisture (KF, CKF)