Physical Characterization

Surface area and porosity are two important physical properties that determine the quality and utility of pharmaceutical materials. Differences in the surface area and porosity of particles within the material, which otherwise may have the same physical dimensions, can greatly influence its performance characteristics. Surface area and porosity play major roles in the purification, processing, blending, tableting and packaging of pharmaceutical products as well as the drug’s useful shelf life, its dissolution rate and bio-availability. In other healthcare applications such as regenerative medicine tissue scaffolds, controlling and optimizing the porosity of the scaffold material will help the tissue regrowth process. In analytical laboratories the use of materials with well-defined pore sizes and high surface areas are used in biochemical and pharmaceutical separation science. Understanding the physical properties of pharmaceutical solid materials is key to successful drug product and process development. These physical properties can have an impact on the material’s bulk properties, product performance, processability, stability and product appearance. The melting point, chemical reactivity, apparent solubility, dissolution rate, optical and mechanical properties, vapour pressure, and density can all be affected. GLP, GCP or cGMP compliant physical characterization services assist with formulation or process development, regulatory submission data, QC testing, GMP lot release and manufacturing troubleshooting. Physical Characterization Testing Capabilities offered by Contraact Analytical service providers include: Calculation of BET surface area: single or multipoint; Determination of pore size and pore size distribution within 1.7 to 500 nm for macro, micro or mesoporous samples; Measurement of surface area as low as 0.001 m2 /g; Predicting reactivity, dissolution and compactness; Measurement of rate and ease of water permeation; Measurement of water vapor sorption - desorption isotherm; Measurement effect of sample environment on crystallinity or amorphous content; Determination changes in flow ability, compaction density and appearance; Determination phase and structural transition between -90 to 400°C; Directly measuring heat capacity; Analysis of complex and overlapping thermal changes - modulated DSC capable; Detection of weak thermal changes; Measurement of the change in sample mass as a function of temperature and/or time Monitoring moisture/Solvent loss [LOD on micro scale] Determination of rate of chemical degradation at various temperatures; Measurement of gas absorption-desorption; Identification of crystalline or semicrystalline structure; Analysis of degree of crystallinity; Detection of impurities; Trace level quantitation of most elements in liquid and solids; Measurement of sizes from 0.01 ?m to 3,500 ?m; Analyzing wet emulsion, suspension and bulk dry dispersion; Determination of diverse sample types: abrasive, fragile, cohesive or agglomerated.