Chemistry, Manufacturing & Controls Pharmaceutical Development Services
Raw Material and Drug Substance Testing

Don't let raw material or excipient 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 excipients and drug substances. Whether your techniques are manual titrations or complex HPLC separations Covance conducts raw material testing in a timely and efficient manner.

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

  • Wet chemistry, FT-IR, HPLC, UV/Vis
  • Thin-layer chromatography, LC/MS/MS
  • Elemental analysis
  • 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

  • OVI by GC/FID or GC/MS
  • Inorganic analysis
  • Moisture determination
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