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Solid State Characterization

Conducting solid state characterization testing is key for understanding the physical properties of your material and whether you have the optimal form for absorption, performance and other important drug properties. Changes in physical properties can directly affect the drug absorption and impact the quality of your API or drug product.

Primera has the expertise and state-of-art instrumentation, to provide a range of solid state characterization testing. We can offer you support in characterization during formulation or process development, in troubleshooting manufacturing problems, quality control testing as well as release testing.

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Instrumentation & Services Include:

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  • Qualitative Crystal morphology and polymorph form identification by X-Ray Powder Diffraction (XRPD). XRPD is widely used to understand the crystallinity of structure of your API or formulation.
  • Quantitative determination of polymorph form content or ratio by XRPD
  • Particle shape and size by Microscope
  • Particle size distribution by Laser Diffraction (Malvern Mastersizer) and Dynamic Light Scattering (Malvern Zetasizer)
  • Thermal analysis and Melting Point determination by Differential Scanning Calorimetry (DSC). 
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