Pharmaceutical Solid State Materials Characterisation
Solid state characterisation of pharmaceuticals, determining physical properties such as particle size, polymorph and morphology of solid dose drug formsSolid 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, drug 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.
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.
Our comprehensive range of solid state services is available to support research or be conducted as Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) compliant programs. Our experience in solid state characterisation and formulation development will help to optimise your solid dose pharmaceutical product. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you to meet and exceed quality, safety and regulatory standards.
Good Manufacturing Practice (cGMP) Services
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