Our company is dedicated to studying the solid-state chemistry of APIs in order to gain a comprehensive understanding of their physical and chemical characteristics. Our goal is to mitigate potential risks during API development. Our team of experts has extensive experience in chiral resolution and is capable of providing high-quality chiral resolution services. If you have any needs, please contact us in time.
Our Services
For chiral APIs, only one enantiomer or diastereomer with biologically active. Therefore, it is crucial to produce high-purity enantiomers or diastereomers. At present, a variety of effective methods for chiral API resolution have been developed, such as mechanical resolution, seeding crystallization, crystallization (direct crystallization & diastereomeric salt resolution), biological resolution, chromatographic resolution, and eutectic split method.
At our company, crystallization is our preferred method for chiral drug resolution as it is more economical and environmentally friendly than chromatography. We have established systematic methods for chiral resolution of enantiomers or diastereomers through crystallization. When developing chiral small molecule APIs, the feasibility of resolving the chiral API through crystallization and the optimal crystallization process conditions can be determined based on the ternary phase diagram of the enantiomer or diastereomer.
What We Can Do?
Chiral Resolution of Enantiomers
Many chiral compound systems usually form a mixed system of enantiomers with a certain chiral purity after synthesis. For this system, we can find a suitable solvent and crystallization system through systematic screening, so as to selectively crystallize or dissolve the enantiomer with biological activity, and achieve chiral resolution of enantiomers, the ee value can reach more than 98%.
Classical Chiral Resolution to Form Diastereoisomers
This method exploits the changes in solid-state and solubility properties between diastereomeric salts to resolve the enantiomers that have biologically active by inoculating the racemic mixture with the pure enantiomers or with a chiral resolving agent during crystallization.
Chiral Resolution of API Intermediates
The chiral resolution of API is usually realized in the final crystallization process of API synthesis, but chiral APIs that are difficult to resolve can be achieved by the resolution of chiral API intermediates.
Our Techniques
| HPLC | RPLC | UPLC | SFC | GC |
| ELSD | MS | NMR | Others | |
Advantages
- The equipment requirement is not demanding, avoiding the complex operation and expensive cost of chiral chromatography.
- No complex theoretical research is required, and the separation can be achieved by finding the appropriate crystallization region through the ternary phase diagram.
- High separation efficiency and high purity of the obtained API.
Delivery
Optimal process parameters for API chiral splitting
Solubility curve, cloud curve, and metastable zone for API in chosen solvents
The ee value of enantiomers
The de value of diastereomers
Other experimental data
Please kindly note that our services are for research use only.
