API Solutions

Analytical Services

Asymchem Services Analytical

Comprehensive Drug Product 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%.