AMPAC Analytical is your partner for cGMP product testing and release services for all phases of drug development and commercial manufacturing.  We provide a wide array of release testing services for Raw Material, Intermediate, API and Drug Product testing. Our labs are equipped to handle hazardous, cytotoxic/high potency compounds as well as Controlled Substances Schedule II through V.

Determination of Physical Properties

  • Appearance/Description
  • Density
  • Refractive Index
  • pH
  • Water Content by Karl Fischer Titration (Coulometric and Volumetric)
  • Color and Clarity of Solution
  • Conductivity
  • Optical Rotation
  • Differential Scanning Calorimetry (DSC)
  • Thermogravimetric Analysis (TGA)
  • Dissolution Testing
  • Osmolality
  • Particle Counting
  • Particle Size Distribution (Wet and Dry)

Identification

  • Appearance/Description
  • Infrared Spectroscopy – ATR, Salt Pellets and Salt Plates (for liquids)
  • Nuclear Magnetic Resonance (NMR)
  • Liquid Chromatography – HPLC and UHPLC
  • Gas Chromatography (GC)
  • Ion Chromatography (IC)
  • Mass Spectrometry (MS)
  • Ultra Violet Spectroscopy (UV)
  • ICP-MS and ICP-OES for Elemental Impurities

Assay and Impurity Testing

We perform a broad range of assay and impurity testing. We can perform assay determinations via standard titration methods. We have extensive experience performing assay, purity and impurity testing utilizing liquid chromatography (both HPLC and UHPLC) with a variety of detection systems including UV, MS, RI and CAD (Charged Aerosol Detection).We can also perform assay, impurity and residual solvents testing utilizing Gas Chromatography systems equipped with FID (Flame-Ionizaton Detection), ECD (Electron Capture Detection), TCD (Thermal Conductivity Detection) and MS. We also perform a variety of elemental impurity testing via ICP-OES (Inductively Coupled Plasma), ICP-MS, and a variety of pharmacopeia methods (Residue on Ignition/Sulphated Ash, Heavy Metals etc.)

Pharmacopeia Testing

We are able to qualify and implement monographs and testing chapters from the various pharmacopeias and standards including USP, EP, BP, JP, FCC, ACS etc.