At WuXi STA we understand the importance of analytical support from laboratory process development to production through to regulatory data submission. Our dedicated analytical science and quality control teams in our US FDA, EU EMA, Japan PMDA, and China NMPA spected facility provide our clients with a full spectrum of analytical method development, validation and testing services to support your needs from preclinical to commercial. We extend our services throughout the product life cycle with dedicated sample and stability management teams.

Our analytical capabilities for drug substance and drug product or standalone analytical services include:

• IPC and release methods development and validation for small and large molecules
• API and Drug Product release testing ICH stability studies for small and large molecules
• Reference standard characterization and qualification 
• Potential Genotoxic Impurities (PGI) method development, validation and testing
• Impurity/degradant isolation and structure elucidation
• Oligonucleotide and Peptide analysis
• Highly potent compound analysis
• Physical property characterization
• Microbial testing

• Chromatography: UPLC, HPLC, Nano HPLC, GC, IC, SEC, SFC
• Mass spectrometry: QTOF, MALDI-TOF, LC-Orbitrap, LC-MS, LC/MS/MS, 2D LC-MS, GC-MS
• Solid state characterizat ion: XRPD, DVS, DSC, TGA with MS interface, PSD, nano- particle size analyzer, polarized light microscope, SEM, surface area analyzer
• Identification: NMR, HRMS, FT-IR
• General test ing: KF, UV-Vis,
• Polarimeter
• Elemental analyzer: ICP-OES, ICP-MS
• USP dissolution apparatus type I and II