Intertek is the industry leader with over 42,000 people in 1,000 locations in over 100 countries. Whether your business is local or global, we can ensure your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world.
Solid state characterisation of pharmaceuticals, determining physical properties such as particle size, polymorph and morphology of solid dose forms
Solid state characterisation is key to understanding the physical properties of pharmaceutical solid materials and ensure optimal physical form. These physical properties can have an impact on the material's bulk properties, formulation performance, processability, stability and appearance.
Our solid state characterisation teams provide a range of services to support pharmaceutical product development during formulation or process development, quality control, GMP lot release testing, and investigational manufacturing troubleshooting. During early development, we offer tailored API solid state characterisation packages to determine particle shape and size distribution, surface area, porosity, moisture or solvent content, solubility, pH, solid state stability, solution stability and thermal properties (by DSC, TGA), enabling you to understand the physicochemical properties for successful formulation development. Crystal morphology capabilities include powder X-ray diffraction (XRPD) for confirmation of polymorph form and polymorph screening.
Additional solid state services to support formulation development include drug-excipient compatibility and particular expertise in nanosized systems such as nano-particles or encapsulation as applied to drug delivery. Spectroscopic structural characterisation is achieved by applying infra-red spectroscopy (FTIR), UV/Vis, nuclear magnetic resonance (NMR) and RAMAN spectroscopy.