Innovative Solutions: Analytical Method Development and Validation Services

Tedor provides comprehensive analytical development and validation services, supporting the drug product development from Pre-Formulation to Commercialization.

Analytical Capabilities:

  • Analytical method development and assessment for small       molecules and macromolecules
  • Stability-indicating assays
  • Chromatography by HPLC, GC, UV-Vis, Refractive Index and IR       spectroscopy
  • Wet chemistry
  • Extractables and leachables
  • Dissolution studies
  • Filter/Flush evaluation
  • Method precision (intermediate and reproducibility)
  • Limit of detection
  • Limit of quantitation
  • Linearity and range
  • Specificity, including forced degradation analysis
  • Robustness
  • Solution stability
    •