Analytical R&D and QC

Enteris’ analytical research and development group has the expertise to support end-to-end development of your drug product.

Our subject matter experts have extensive knowledge of current and evolving FDA and ICH guidelines and apply a risk-based, phase-appropriate approach to cGMP analytical activities such as specification setting, analytical method development, and analytical validation.

We provide partners with total integrated CMC services, including analytical method development, analytical validation, physicochemical characterizations of the drug substance, solubility studies, excipient compatibility, together with binary mixtures, forced degradation studies and identification of impurities, container closure screening and selection, and stability studies.


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The Enteris analytical research and development group comprehensive scientific expertise and our laboratory is fully equipped to serve your needs.

  • HPLC/UPLC
    • Diode array detection
    • Variable wavelength detection
    • Charged aerosol detection
    • Fluorescence detection
  • Karl Fischer Titration
  • Dissolution Apparatus
    • Apparatus 1 (baskets)
    • Apparatus 2 (paddles)
    • Apparatus 3 (reciprocating cylinder)
  • Intrinsic Dissolution
  • UV/Vis Spectrophotometry
  • FTIR Spectroscopy
  • ICH Stability Storage
    • 25°C / 60% RH
    • 30°C / 65% RH
    • 40°C / 75% RH
    • Other flexible units
  • Other storage including 2-8°C, -20°C, and -80°C

The Enteris analytical research and development group comprehensive scientific expertise and our laboratory is fully equipped to serve your needs.

  • HPLC/UPLC
    • Diode array detection
    • Variable wavelength detection
    • Charged aerosol detection
    • Fluorescence detection
  • Karl Fischer Titration
  • Dissolution Apparatus
    • Apparatus 1 (baskets)
    • Apparatus 2 (paddles)
    • Apparatus 3 (reciprocating cylinder)
  • Intrinsic Dissolution
  • UV/Vis Spectrophotometry
  • FTIR Spectroscopy
  • ICH Stability Storage
    • 25°C / 60% RH
    • 30°C / 65% RH
    • 40°C / 75% RH
    • Other flexible units
  • Other storage including 2-8°C, -20°C, and -80°C

KNOWLEDGE CENTER

Expand your knowledge. The Enteris BioPharma Knowledge Center is a library of educational tools.

LEARN MORE

KNOWLEDGE CENTER

Expand your knowledge. The Enteris BioPharma Knowledge Center is a library of educational tools.

LEARN MORE