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- - elaborated report
- - swift processing
- - expertise of our team
Solvates and hydrates raise a set of challenges, concomitant to polymorphism, but that need to be dealt with specifically. Issues direct environment of the sample which has a direct influence on the stability of solvated / hydrated forms (relative humidity, temperature). As an example, a stable form in suspension may differ from the stable one under room atmosphere.
Holodiag develops a robust process for obtaining the desired solvate/hydrate. The process also takes into account the whole development strategy of your API by studying the solid state under various conditions (temperature, %RH, solvent composition). This enables to understand the relationships between the different solid states and determine stability parameters for:
- target market environment
- process modification
- preparing ICH test
It also can lead to new solid phases, only accessible through a desolvation/dehydration process.
Activity tracking and reporting
Scheduled reporting and steering committees allow you a real-time monitoring of the studies. Besides, Holodiag delivers a high quality report which is a tool in the decision making process. This report highlights the key points together with advices for further development steps.
Information and cost
Should you need more details or a quotation, please contact us.