API Analytical
Home | Services & Solutions | Analytical | API Analytical
Analytical Development
Our analytical development teams have more than 750 scientists supporting from API process development to commercial manufacturing at any scale. Equipped with state-of-the-art instruments and located at the same site with API process development and manufacturing team, our analytical services will streamline your small molecule API development with customized, flexible, and integrated analytical solution.
With more than 1,000 HPLC and UPLC, 200 GC and HSGC, as well as 50 LC-MS, GC-MS, IC, SFC, our team developed 6,000 fit-for-purpose assay and impurity chromatographic methods in 2023. In 2023, Our team also developed more than 2,000 non-chromatographic methods, covering all popular types of spectroscopic and physicochemical analysis.
Experience Highlights:
- 1000+ GTI (Genotoxic Impurity) parts per million detection methods
- 10+ nitrosamine control projects with 2500+ GTI methods available
- 400+ structure confirmation/elucidation with interpretation for IND and NDA fillings
750+ Analytical Scientists
In 2022:
- 6,000+ chromatographic methods developed
- 1,000+ non-chromatographic methods developed
920+ QC Analysts
In 2022:
- 500+ projects supported
- 11,000+ batches released
Quality Control
Our quality control teams have more than 1,000 scientists supporting hundreds of projects at all stages every year, ensuring the highest quality standard meeting all regulatory requirements. Our facilities are equipped the latest digital systems available for onsite and remote inspections. In addition, we support high potency drugs with dedicated high potency QC labs with OEL 10 ng/m3.
In 2023, our API QC team
- Supported 500+ projects, including 50+ PPQ projects
- Released 11,000+ batches
Our Services
Include but not limited to:
- Chromatography including HPLC, UHPLC
- Solid state development, powder characterization, and material science
- Element impurity analysis including ICP-MS
- ICH-compliant study
- Bioanalytical testing including microbial testing
