Our company is a company dedicated to the research of API polymorph screening. We have a team with rich experience in the field of polymorph screening and we can perform polymorph screening of any API to determine the most suitable polymorph for your product using a variety of analytical methods such as DSC, XRPD, FTIR and solubility/solubility testing. In addition, our company can support your application by identifying additional polymorphs for intellectual property protection purposes. If you have any needs, please feel free to contact us, we will provide you with a one-stop service of polymorph screening.
Why Polymorph Screening?
- Polymorph of APIs are different chemical entities with different physicochemical properties such as solubility, dissolution rate and melting point, which affect their biological activity, pharmacokinetic properties and stability.
- Polymorph of a drug may not be thermodynamically stable and during the formulation or storage of the drug, it may transform into another polycrystalline form, which may lead to unqualified testing of the drug substance or dosage form.
- Identifying as many polymorphs of an API as possible can protect the relevant intellectual property associated with the new API and prevent the API from being produced by a generic company.
Our Service
API polymorphism refers to the formation of two or more different crystal forms of the same API during crystallization. Since the different crystal forms of API may seriously affect the stability, bioavailability, product quality and therapeutic effect of the drug, polymorph research is an important content that cannot be ignored in the drug development process. Our company can perform an exhaustive API polymorph screening for you.
Initial or rapid polymorph screening of APIs
Comprehensive polymorph screening of APIs
Determination of the stability of different API polymorphs
Research on inter transformation relationship between crystal forms
Amplification of selected polymorphs
Development of quantitative polymorph analysis methods
Rapid powder X-ray diffraction characterization
Workflow for API Polymorph Screening
Our Techniques
| Crystallization techniques | Slurry |
| Cooling |
| Anti-solvent addition |
| Evaporation |
| Grinding |
| Polymorph characterization | X-ray diffraction: single crystal, XRPD |
| Spectroscopy: Mid FT-IR, Raman, solid-state-NMR |
| Thermal analysis: DSC (differential scanning calorimetry), TGA (thermal gravimetric analysis), melting point, hot-stage microscopy |
| Other: microscopy, DVS (dynamic vapour sorption), solubility / dissolution, SEM (scanning electron microscopy) |
Our Advantages
- Our scientists have performed hundreds of API polymorph screenings and have extensive project experience.
- The fusion of sensitive and rapid analytical techniques with sophisticated data analysis tools accelerates the quantification and evaluation of API polymorphs.
- We have advanced polymorph screening laboratories and equipment.
Delivery
| Physicochemical properties of API | Dissolution/solubility of API polymorphs |
| Stability of API polymorphs | Bioavailability of API polymorphs |
| Physicochemical properties of API polymorphs | Other experimental data |
Please kindly note that our services are for research use only.
