API Solutions

Analytical Services

Asymchem Services Analytical

Comprehensive Services to Support Manufacturing

The analysis team at Asymchem knows how to support a variety of needs at various stages of drug development. Our experts bring full quality control and quality assurance support to all areas of GMP and non-GMP manufacturing, including analytical method development and validation, stability study, structure identification, impurity preparation/characterization, standard sample preparation/characterization, chemical properties characterization, cleaning validation, and more.

Key Services

  • Analytical method development and validation
  • Stability testing
    • Force degradation studies
    • Stability testing to support clinical studies
    • Stability testing under ICH guidelines
  • API reference standard qualification
  • Spectroscopic structure confirmation
  • Release testing
  • Identification product and pathway
  • Cleaning validation
  • Physical property characterization
  • Microbiology testing
    • Endotoxin/aseptic/potency/positive bacteria testing

Major Analytical Equipment

  • HPLC, GC, ICS-1500/5000, UPLC, SFC
  • NMR (300, 400,500MHz), ICP-OES, XRD, FTIR, UV-vis, OR
  • pKa logP/D test, HS KF-V20, KF-C20, TOC, melting point detector
  • TGA, DSC, DVS, PSA, potentiometric titrator
  • Stability chambers