Impurity Identification & Characterization

EAG has decades of experience performing impurity identification and contaminant investigations. When combined with our expertise in method development, method validation and stability testing on active pharmaceutical ingredients (APIs) and drug products (DPs), EAG is the perfect choice to aid in any follow-up support after corrective action is taken. We will also be there to provide solutions to your CMC and Quality Control analytical needs.

EAG uses a wide array of instrumentation and analytical techniques, so we have the right tools to address any type of contaminant or impurity identification, in any formulation.

  • For isolation and characterization of visible contaminants:  Fourier Transform Infrared Spectroscopy (FTIR), and Scanning Electron Microscopy/Energy Dispersive X-ray Analysis (SEM-EDXA).
  • For organic materials: Gas Chromatography with Mass Selective detection (GC/MS)
  • For inorganic materials:  Inductively Coupled Plasma with Mass Spectrometry (ICP-MS)
EAG supports development of generic drugs

Would you like to learn more about Impurity Identification & Characterization?

Contact us today for your impurity identification & characterization needs. Please complete the form below to have an EAG expert contact you.

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