API Solutions

Analytical Services

Asymchem Services Analytical

Comprehensive Services to Support Manufacturing

The analytical team at Asymchem provides comprehensive analytical support to process development, production, and testing services for both drug substances and drug products. Our experts have a full spectrum of know-how 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-cycle from pre-clinical to commercialization. We can provide in-house stability studies, structural illustrations, impurity preparation/characterization, physical-chemical property characterization, cleaning validation, process analytical technology (PAT) and more.

Key Services

  • Analytical method development, validation and transfer
  • Stability testing
    • Force degradation studies
    • Stability testing to support clinical studies
    • Stability testing under ICH guidelines
  • API reference standard qualification
  • Spectroscopic structure confirmation
  • Raw material release, in-process control, and release testing
  • Identification product and pathway
  • Cleaning validation
  • Physical property characterization
  • Microbiology testing
    • Endotoxin/aseptic/potency/positive bacteria testing

Major Analytical Equipment

  • Chromatography: HPLC, GC, ICS-1500/5000, UPLC, SFC
  • Mass Spectrometry: LC-MS, LC-MS/MS, LC-TOF, ICP-MS, GC-MS, HS GC-MS
  • Spectrometer: NMR (300, 400, 500MHz), ICP-OES, XRD, FTIR, UV-vis, OR
  • Physical and Chemical Testing: pKa logP/D test, HS KF-V20, KF-C20, TOC, melting point detector
  • Material Characterization: TGA, DSC, DVS, PSA, potentiometric titrator
  • PAT: Online- FBRM, IR, HPLC, PVM
  • Stability chambers:  25℃/60%R.H., 30℃/65%R.H., 40℃/75%R.H. ,, 2-8℃, -20℃, -80℃, 25~100 ℃, 10~80% .H.