In the production process of API, crystallization is the last critical step of solid API, and an excellent crystallization process can make API have high-quality crystals. Therefore, crystallization process development and optimization is a very important step in the pharmaceutical production process. Our company has been committed to the research and development of API crystallization process for many years. With our professional researchers and advanced laboratory equipment, we can provide you with a one-stop service for the development and optimization of API crystallization process. If you have any needs, please feel free to contact us.
Our Service
Crystallization is the process by which APIs precipitate out of a vapor, solution or melt in a crystalline state. When crystallized, APIs form different crystalline structures if different solvents and processes are used. The difference in crystalline form results in different physical and chemical properties such as solubility, melting point and stability. For crystalline products, the crystalline quality is generally judged by several indicators such as purity, crystalline shape, crystal habit, particle size distribution and dissolution rate. Our company's crystallization process development and optimization service aims to help customers develop a scientific and reasonable crystallization process to produce selected crystalline forms and improve the overall quality of the product by optimizing yield, solvent residue, particle size and particle size distribution, bulk density, etc.
Crystallization Process Development
Crystallization Process Development Workflow
Generally, crystallization process design is carried out through concentration/suspension density, supersaturation, system mixing effect, seed crystal, secondary process control, end point conditions, etc.
Crystallization Techniques
| Techniques | Description |
|---|
| Cooling crystallization | Solubility changes significantly with temperature
Sufficiently low solubility at low temperatures
The solute is stable in the cooling range |
| Solvent crystallization | Adequate solvent consumption
Does not form solvates |
| Reaction crystallization | Crystallization process with salt formation or eutectic formation |
| Ultrasonic crystallization | For the preparation of special seeds |
| Spherical crystallization | Divided into wet spherical coalescence method and emulsified solvent diffusion method, it is suitable for particle properties that cannot be improved by conventional means. |
| Others | Supercritical fluid crystallization, high-throughput crystallization, quasi-emulsion crystallization, micro-recrystallization, etc. |
Crystallization Process Optimization
If the goals of the crystallization process have been determined, such as obtaining the only target crystal form, obtaining high-purity products, obtaining granules suitable for preparations, simplifying operations and reducing costs, etc. Different research methods are selected for different process objectives, and the general optimization methods are as follows:
| Crystal structure and shape control | Crystal size and distribution control |
| Chemical purity and residual solvents control | Optimisation of process parameters in crystallisation production |
Characterization of API Crystallization
We can characterize the API crystals by X-ray powder diffractometer, differential scanning calorimeter, Raman micro spectrometer, scanning electron microscope, water molecule adsorption instrument, and optical microscope to ensure high-quality crystals are obtained.
Our Advantages
- Experienced experts can choose the right crystallization method for you according to your goals.
- We have advanced crystallization equipment.
- High efficiency and yield.
Delivery
| Physicochemical properties of API | Oversaturation of API |
| Factors affecting stability | Shape and structure of API crystals |
| API crystal particle size | Other experimental data |
Please kindly note that our services are for research use only.
