ARx Product Characterization & Testing

ARx implements extensive product characterization activities for active pharmaceutical ingredients (APIs), excipients, reference listed drugs, and development prototypes to achieve a robust product formulation. By characterizing products and fundamentally understanding how each formulation ingredient contributes to the critical quality attributes, the ARx team increases the likelihood for success in clinical trials and product submissions.

Characterization capabilities include:

  • Permeation/diffusion studies
  • Total organic carbon (TOC)
  • Water content analysis
  • Moisture sorption analysis
  • Dissolution
  • Disintegration
  • Water activity
  • GC/Residual solvent
  • TGA
  • DSC
  • DMA
  • SEM/EDS
  • Particle Size Distribution
  • Fluid Rheology
  • FTIR
  • HPLC
  • Size exclusion chromatography
  • Assay
  • Content uniformity
  • Impurities and related substances
  • Excipient compatibility
  • Buffer capacity
  • ICH Stability
  • Physical and mechanical testing
    • Tensile
    • Peel force
    • Static & dynamic shear
    • Release force
    • Coat weight analysis
    • Coating thickness