Ensure product efficacy through drug characterization studies.
Material characterization, the study of the physical properties of a solid drug substance, has evolved into an increasingly important aspect of modern drug formulation. Properties such as particle size and morphology, surface area, and crystalline phase are known to have significantly influenced the efficacy of a final drug product. Additionally the development of new regulatory guidance, Part V of the Federal Register, as well as economic incentives to reduce development time has contributed to the growing interest in material characterization.
Micron Technologies has the experience and capacity to provide rapid turnaround for the following material characterization techniques:
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Particle Size Analysis by Laser-Diffraction X-ray Powder Diffraction (XRD) Differential Scanning Calorimetry (DSC) Thermogravimetric Analysis (TGA) Scanning Electron Microscopy (SEM) and Optical Microscopy Surface Area Analysis |
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Dynamic Vapor Sorption (DVS) HPLC and GC Dissolution Karl Fischer Titration Stability Testing and Sample Storage Release Testing |
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