Physical properties screening

In addition to screening options available at Solid Form Solutions, we offer a cGMP physical property and developability assessment on batches of API.

Amongst the techniques available are:

  • X-ray Powder Diffraction (XRPD)
  • Variable Temperature/Variable Humidity XRPD (VT/VH-XRPD)
  • Single Crystal X-ray Diffraction
  • Thermogravimetric Analysis (TA/DTA)
  • Differential Scanning Calorimetry (DSC)
  • Polarised Light Microscopy (PLM)
  • Hot-Stage Microscopy (HSM)
  • HPLC Analysis
  • Metal Analysis
  • Infra-red Spectroscopy (IR)
  • Scanning Electron Microscopy (SEM)
  • Storage Tests (To ICH Guidelines)
  • Photostability (To ICH Guidelines)
  • Dynamic Vapour Sorption (DVS)
  • Nuclear Magnetic Resonance (1H, 13C, 2-D analysis)
  • Solid-State NMR
  • Particle Size Analysis
  • Counterion Analysis (i.e. chloride, ammonium analysis)
  • Dissolution and Intrinsic Dissolution Testing (USP 2)

TGA Results:

Process Overview

An example of a TGA results trace (click to enlarge).