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Crystallization Process Development

WuXi STA’s crystallization teams are experienced in crystallization process and particle size reduction development including but not limited to polymorphism, purity, residual solvents, particle size distribution, morphology, filtration, and drying investigation to ensure delivery of drug substance with desired properties. The facilities are located at Shanghai Waigaoqiao,  Shanghai Jinshan and Changzhou sites.

Our crystallization teams are equipped with powder X-Ray Diffractometers (pXRD), Differential Scanning Calorimeters (DSC), Thermal Gravimetric Analyzers (TGA), Polarized Light Microscopes (PLM), Scanning Electron Microscopes (SEM), Particle Size Distribution analyzers (PSD), and Dynamic Vapor Sorption (DVS) for solid state analysis. PAT tools, such as Focused Beam Reflectance Measurement (FBRM), reactor IR (online IR), and BlazeMetrics, are also used for the development.

In 2023, crystallization teams supported 500+ compounds, 70+ late-phase and commercial steps for API process development.  Learn more about our salt and polymorph screening services

Milling and Micronization

We routinely provide four types of micronization support from laboratory scale to production scale. And we also support high potency compounds with an Occupational Exposure Limit (OEL) of 10 ng/m³. 

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Wet Mill

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Pin Mill

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Jet Mill

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Cone Mill

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