Crystallisation Development
Crystallization Service is aimed at developing a bench scale process into a robust procedure that can easily be transferred to plant.
Crystallisation is the process for the formation of solid crystals from a uniform solution. Crystallization is a key process step required during the production of most active pharmaceutical ingredients (API) and its intermediates, the inability to manufacture a consistent crystalline form often leads to costly project delays.
Crystallization is an inherently challenging process operation Crystallization process is blend of art and science and even small variations in the process can have profound impact on the outcome for both the API producer and its business pharmaceutical partners.
Well-designed and controlled crystallization Process Development for projects by controlling polymorphism, solvates / hydrates, enantiomeric resolution.
Crystallisation Process Development Service is aimed at developing a bench scale process into a robust procedure that can easily be transferred to plant.
Our Crystallisation Process Development services includes :
> Initial polymorphism screening for early stages candidates.
> Polymorph screening, optimisation and control.
> Morphology habit screening, optimisation and control.
> Solvate screening, optimisation & control.
> Correlation of solid-state form with crystallisation conditions.
> Salt and co-crystal screening, optimisation & control.
> Characterization of crystalline salts.
> Use of solvent mediated as well as solvent free crystallization procedures.
> Crystallization screening methodology adaptable to the API properties.
> Crystallization screening to discover the optimal chiral resolution agent and crystallization solvent.
> Co-crystal screening of pharmaceutical ingredients with selected co-crystal formers.
> Development and scale-up of robust crystallization procedures.
> Optimization of crystallization processes (yield, desired polymorph, purity, particle size, and crystallanity, etc.
> Technology transfer of crystallization process.
