Regulatory-driven analytical services for drug development
We provide regulatory-driven analytical services for drug development including monitoring and quality control for APIs, intermediates, raw materials and finished products.
Our services encompass:
- Method development and validation,
- Characterization of reference materials,
- Stability testing, routine sample analysis,
- GLP batch release testing and other special studies.
Our experienced scientists readily make efficient and productive solutions tailored to your projects. Our diversified and best-in-class analytical instruments enable us to provide optimized services for your individual needs.
In supporting CMC programs, pre-formulation, formulation and product release, our laboratories are equipped with advanced and qualified instruments. All written procedures and SOPs (standard operating procedure) are strictly followed so that data integrity is maintained with complete and accurate results and traceable records.
WuXi AppTec’s record of successful on-site inspections for a number of domestic and international projects shows our readiness to extend these services to support the development of your products.
Instruments in labs | API or Drug Product | Description | ||||
In Process Control | Reference Standardization | Method development validation | Compound release | Stability study | ||
HPLC | Equipped with all kinda of detectors include UV, PDA, CLND, ELSD, CAD, FLD | |||||
HPLC/MS | Equipped with all kinds of MS detectors including single quadrupole, triple quadrupole, TOF, Orbitrap Elite | |||||
GC | Both headspace and direct injection mode available. | |||||
GC/MS | Both headspace and direct injection mode available. | |||||
NMR | 500MHz or 400MHz, BBFO, smart probe, cold probe available | |||||
X-Ray Powder Diffraction | Nondestructive technique for the identification of crystalline phases in powdered solid samples | |||||
Elemental Analysis | Quantitative elemental composition | |||||
ICPMS | Performed on solid or liquid samples. They can determine a range of metals and several non-metals. Trace unknowns can also be detected and identified | |||||
IR | Both KBr pellet and ATR mode available | |||||
TGA DSC | More than one brand of high sensitive equipment available | |||||
Dissolution | ||||||
Polarimeter | 6 wavelengths are available: 589nm, 546nm, 365nm, 405nm, 436nm, 633nm | |||||
stability and photostability chamber | With all ICH conditions | |||||
Green: Often Used | Blue: Sometimes Used
