13 Nov 2024
The aim of a crystallization process development is to find a crystallization process which can stable produce the optimal solid form with all desired properties such as particle size, particle shape, bulk density, purity, yield, residual solvent content, etc.
Chemical Purity | Physical Form & Purity | Physical Properties |
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Experienced engineers agree that crystallization is an inherently challenging process, one that involves a blend of art and science. Even small variations in the process can have profound impact on the outcome for both the API producer and its business pharmaceutical partners, which incorporate the API into finished drug formulations.
At Crystal Pharmatech, successful crystallization development is based on a fundamental understanding of physicochemical and engineering principles, implementation and development of technologies and expertise in specialized areas.
Crystal Pharmatech provides featured crystallization process development services including:
Crystallization method selection – Cooling crystallization and/or anti-solvent crystallization
Solvent and/or Anti-solvent selection
Crystallization form control
Crystallization parameter optimization
- Controlling supersaturation, seeding, temperature ramp rate, anti-solvent volume/addition rate, productivity, filtration, drying, etc.
Crystallization output achieved
- Control over impurity, morphology, residual solvent, particle size distribution, and enhanced productivity