API Solutions
Analytical Services

Comprehensive Analytical Services to Support Development and Manufacturing
The analytical team at Asymchem provides comprehensive analytical supports to R&D activities, process development, production, and testing services for both drug substances and drug products. Our experts have a full spectrum of know-how knowledge and experiences with small molecules, biological molecules, peptides, oligonucleotides, ADCs and many other chemical modalities. Dedicated analytical R&D and quality control teams conduct phase-appropriate method development, validation, verification and transfer to support projects through their life-cycles from pre-clinical to commercialization. In addition, we can provide in-house stability studies, structural elucidation, impurity preparation and characterization, physicochemical property characterization, cleaning validation, process analytical technology (PAT) and more. Up to now, hundreds of different projects with a wide range of chemical modalities at various clinical and commercial stages have been successfully analyzed, developed and delivered at Asymchem.
Key Services
- Analytical method development and optimization, validation, verification and transfer
- Stability testing under ICH guidelines
- Force degradation studies
- Stress stability testing
- In-use stability testing
- Short-term (accelerated condition) stability testing
- Intermediate condition stability testing
- Long-term stability testing
- Reference standard qualification
- Spectroscopic structural elucidation
- Identification of products and pathways
- Excipient and packaging material release
- Raw material release, in-process control, and product release testing
- Cleaning validation
- Physiochemical property characterization
- Microbial testing
- Microbial limits/endotoxin/sterility testing
- Potency/positive bacteria testing
Major Analytical Equipment
- Chromatography: HPLC, UPLC, GC, HS-GC, ICS-1500/5000, SFC
- Mass Spectrometry: LC-MS, LC-MS/MS, LC-TOF, GC-MS, HS GC-MS, ICP-MS
- Spectrometer: NMR (300, 400, 500MHz), ICP-OES, XRD, FTIR, UV-vis, OR
- Physical and Chemical Testing: pKa, logP/D, HS KF-V20, KF-C20, TOC, melting point detector
- Material Characterization: TGA, DSC, DVS, PSA, potentiometric titrator
- PAT: Online- FBRM, IR, HPLC, PVM
- Dissolution apparatus: Aglient, Distek and Logan brands
- Stability chambers: 25℃/60%R.H., 30℃/65%R.H., 40℃/75%R.H., 2-8℃, -20℃, -80℃, 25~100 ℃, and 10~80%.