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Crystallization Process

After selecting and characterizing the appropriate solid form of an API, a robust crystallization process at larger scale will be developed. Parameters such as yield, chemical purity, polymorphic purity, solvent class (according to ICH guidelines), residual solvent content and cost, will be optimized. Obtaining a crystalline material with a consistent particle size and morphology (external shape, habit) is also important. The developed crystallization process is transferred for validation at larger scale, in order to enable the production of the batches required for the clinical trials.

TeraCrystal technical team has the ability and expertise to help at all stages of crystallization development, from initial screens at microgram scale right through to kg scale. We have extensive experience in validating crystallization parameters and testing process robustness and if required, all procedures can be efficiently transferred to our customers.

Contact us: tel/fax: +4(0)364.439.995