Intertek ASG Laboratory > Pharmaceutical and Biopharmaceutical Services > Reference Standards Services

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Reference Standards Services

Comprehensive reference standard services are available from Intertek ASG, including initial characterization, expiry dating, and re-certification, as well as storage and distribution. These services can be applied to reference materials used for assay, degradation product quantification, process impurity identification and quantification. Applications also include sample limited Reference Standard Materials (RSMs) such as biologics or similar complex and expensive materials. RSM programs can be offered for primary, secondary, compendial and non-compendial reference standards. Impurities (organic and inorganic) and residual solvents can be identified and quantified.

Complete Characterization:

• Identification
  • Elemental Microanalysis (CHN, CHNS)
  • Infrared Spectroscopy (IR)
  • UV/Vis Spectroscopy
  • 2-D and 3-D NMR (1H & 13C)
  • Mass Spectrometry (MS)

      

• Physical Characterization

• Melting Point
• Boiling Point
• Optical Rotation
• Thermogravimetric Analysis (TGA)
• pH

• Purity
  • HPLC
  • LC-MS
  • GC
  • GC-MS
  • Residual Solvents
  • Titration
  • Karl Fischer (KF)
  • Metals Screen
  • Residue on Ignition (ROI)
  • Differential Scanning Calorimetry (DSC)
  • Chiral or Diasterometic Purity
  • Impurity Profile

Complete Reference Standard Materials (RSM) Program for Corporate RSMs:

• Initial characterization
• Generation of a certificate of analysis
• Expiry dating through stability testing
• Repository & distributor
• Periodic re-qualification
• Complete characterization of sample limited reference standard materials (RSMs)
• Especially designed for impurities, metabolites, or other expensive materials

Applications:

• Compendial RSM
• Non-compendial RSM
• Sample limited RSM
• Biologic macromolecules including:
  • oligonucleotides
  • recombinant proteins
  • vaccines
  • antibody therapeutics
• Polymeric and oligomeric species
• Pharmaceutical analysis