Raw Material and Drug Substance Testing

Don't let raw material contamination derail your product development program. In light of recent, highly publicized heparin and melamine contamination alerts, the importance of raw material testing for pharmaceutical products has increased. Engage the experts at Covance to test drug substances in your programs to ensure potency, purity, and identity.

Augment your resources

Eliminate the burden of raw material testing for your staff. Competent and committed, Covance has expertise in all analytical techniques to ensure the highest level of quality testing for drug substances.

Techniques for appearance, physical assessment, drug content, identity and characterization:

  • Wet chemistry, FT-IR, HPLC, UV/Vis
  • Thin-layer chromatography
  • NMR
  • Salt identification
    • Ion chromatography
  • Thermal characterization
    • Thermal Gravimetric Analysis (TGA),
    • Differential Scanning Calorimetry (DSC)
  • X-ray crystallography
  • Drug potency, degradation products, impurities
  • HPLC, GC
  • Moisture determination
  • Impurities determination
  • Residual solvents by GC/FID or GC/MS
Biomolecules

Develop, characterize, test and validate with Covance, no matter what technique or molecule you're pursuing. Our experience covers a wide range of biomolecules, including:

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