Our process analytical sciences group provides unparalleled support for research, development, and commercial production of late stage intermediates and APIs.

At STA we understand the importance of analytical support in pharmaceutical development and manufacturing. Our dedicated process analytical science teams provide our clients with analytical method development and all other services required to support their regulatory needs.

Services Offered

  • Analytical method development, qualification and validation for
    • Assay and impurities
    • Water content
    • Chiral analysis
    • Residual solvents
    • Identification
    • Trace metals analysis
    • Counter-ion content
  • IPC and release testing
  • Impurity isolation and structure elucidation
  • Reference standard qualification
  • ICH-compliant stability studies
  • PGI method development, validation and testing
  • Specification and other regulatory filing documentation preparation

Our experienced analytical teams have the following key instrumentation to support their activities

  • Chromatography: UPLC, HPLC, LC-MS, GC, GC-MS, IC, SFC
  • Solid state characterization: DSC, TGA, XRPD, PSD, Polarized light microscopy
  • Elemental analysis: ICP-OES
  • Identification: NMR, FT-IR
  • General testing: KF, UV-Vis, Polarimeter

Building on the foundations of STA business, we understand from personal experience what you need and expect from a service provider.

Contact us