Analytical Development

WuXi AppTec’s full range of analytical development services includes method development and validation, stability study, GMP release of API and drug products, CMC services, and reference standard characterization. State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality services.

GMP Services

  • Method Development and Validation
    • Development and validation of analytical methods for APIs and formulated products.
    • API
      • Potency and Impurities; Counter-ion; Water; Chiral Purity; Residual Solvents; Toxic Metals; Particle Size; X-Ray Powder Diffraction; ID
    • Drug Products
      • Assay; Content Uniformity; Related Substances; Dissolution Profiling; Water Activity
    • Deliverables
      • Method Development Report; Method Validation Protocol; Method Validation Report; Method Monograph
  • Stability
    • Experimental/Probe Stability; Registration Stability; Post-Approval Stability Reference Standard.
    • Comprehensive characterization for customer reference standard or other key compounds. A full characterization report or COA will be issued.
    • Storage Conditions
      • 40ºC/75%RH, 30ºC/65%RH and 25ºC/60%RH or customized conditions including 5ºC, 20ºC
    • Stability Chambers
      • Qualified (IQ/OQ/PQ and Mapping); four types of power supply; real time temperature and humidity monitor; autodial alert system
  • Release of API and Clinical Trial Material

CMC Services

  • IND Readiness Testing Package
    • Lab work and documentation for structural elucidation and physicochemical properties including NMR (1H, 13C, 2D), IR, HR-MS, UV, Raman, Elemental Analysis, X-Ray, XRPD, DSC, TGA, Aqueous Solubility, Nonaqueous Solubility, Intrinsic Dissolution, Log P, Log D, Hygroscopicity, Melting Point, pKa, Optical Rotation, etc.
  • Full CMC Package
    • One-stop services for all regulatory filing CMC requirements from API development, analytical development, stability study and formulation manufacturing through CMC documentation; integrated development services.

Biologics Analysis/Stability Studies

  • SDS-PAGE
  • Capillary Gel Electrophoresis (CGE both reduced and non-reduced)
  • cIEF for Charge Variants
  • SEC HPLC for Aggregate Content
  • Glycan Assay for Glycosylation Profile
  • Oxidation Assay for Methionyl Oxidation Content
  • Peptide Mapping for Molecular Identification
  • UV Determination of Protein Concentration
  • pH
  • Moisture by Karl Fisher

back to top