METHOD DEVELOPMENT & VALIDATIONS

  • Stella Hill is highly specialized in the area of HPLC and GC method development.
  • Stella Hill has an established reputation for developing methods for difficult and unusual compounds in complex products and matrices.
  • Stella Hill develops Stability Indicating Methods utilizing a wide range of detection modes, i.e. UV, Fluorescence, Evaporative Light Scattering detection (ELSD), Pulsed Amperometric detection (PAD), Conductivity, etc.
  • Methods developed by our staff includes complex stability indicating methods for oligonucleotides, peptides and proteins, as well as other small molecules, and includes RP-HPLC, AX-HPLC, IC, SEC-HPLC, etc.
  • Our Quality Control Laboratory utilizes our in-house Method Validation program and will work with our clients to accommodate their validation protocols.
  • All Validations are cGMP/ICH compliant.
  • Stella Hill’s Quality Assurance Unit reviews 100% of the raw data and final reports and keeps accurate and complete documentation.