AMPAC Analytical conducts reference standard qualifications for proprietary customer compounds, including novel raw materials, intermediates, and active pharmaceutical ingredients. We offer cGMP qualification and characterization services to establish the identity and potency for Certified Reference Standards (CRS). We apply multiple spectroscopic techniques (including IR, NMR, and MS) to establish identity and apply titration, HPLC, GC, and other techniques to establish potency values.

Reference Standard Qualification Techniques

  • Water Content by Karl Fischer Titration including KF Oven (Coulometric and Volumetric)
  • Differential Scanning Calorimetry (DSC)
  • Thermogravimetric Analysis (TGA)
  • Optical Rotation
  • Particle Size Distribution (Wet and Dry)
  • Liquid Chromatography (UHPLC/HPLC)
  • Gas Chromatography (GC)
  • Ion Chromatography (IC)
  • Mass Spectrometry (MS)
    • Including hyphenated techniques LC-MS and GC-MS
    • Exact mass, high resolution LC-MS is also available
  • Infrared Spectroscopy
  • Nuclear Magnetic Resonance (NMR)
    • 1H NMR (one and two dimensional)
    • 13C NMR
    • 31P NMR
    • 19F NMR
  • Ultra Violet Spectroscopy (UV)
  • ICP-MS and ICP-OES for Elemental Impurities and Composition Analysis
  • Various Compendial methods (i.e. ROI, Sulfated Ash, Heavy Metals USP<231>)

Reference Standard Preparation

In concert with our parent company, AMPAC Fine Chemicals, we offer custom synthesis and purification of reference standards and authentic materials, followed by certification of the material.

Storage, Logistics, and Traceability

Our customers rely upon AMPAC Analytical’s logistical support to store, ship, and track their reference materials. AMPAC Analytical maintains qualified, monitored, secure ICH storage conditions. Our reference standard coordination provides the assurance that sufficient reference standard quantities, held at the correct conditions, are available for shipment worldwide.