Decide on the best crystalline form of your API with the support of CARBOGEN AMCIS' crystallization experts
Defining the best crystalline form of an API is crucial in drug development, since it has a significant impact on the effectiveness of the formulation and, therefore, the bioavailability of the finished dosage form. CARBOGEN AMCIS has established a capability that supports our customers with crystallization investigations, including solubility tests, salt screening, and optimization of the crystallization process and the solid-liquid separation in the API isolation process. Polymorphism screening complements the service portfolio.
We offer online monitoring of critical parameters such as particle size, turbidity, temperature, and pH value. We also provide analytical services, dedicated to solid phase characterization; including hot-stage microscopy, differential scanning calorimetry and X-ray powder diffraction.
Our Crystallization Capabilities
- Salt screening and salt selection
- Polymorphism screening
- Solubility and crystallization screening; optimization of crystallization processes
- Small-scale up with MSZW or solubility curves
- Identification of critical parameters for scale-up, definition of filtration and drying parameters, polymorph control
- Isolation of amorphous solids via spinodal degradation, spray-drying and lyophilisation
- Online monitoring of particle size and turbidity
- Solid-state characterization (DVS, XRPD-DSC, water activity, DSC, TGA, hot stage)
- Pre-formulation support