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Product Chemistry

EAG conducts product development studies in response to chemical and physical analysis requirements for product chemistry under Good Laboratory Practices (GLPs). We offer physical and chemical analyses required to characterize active ingredients, product components and their degradants, with ample capacity for storage stability studies and use of radiolabeled materials (14C and 3H) as needed.

Product Identity, Composition and Analysis

  • Analysis of impurities, including metals analysis
  • Preliminary analysis
  • Certified limits
  • Analytical enforcement method, including method transfers, refinements, and validations
  • Submittal of samples
  • Certificates of Analysis

Physical and Chemical Properties Determination (including, but not limited to)

  • Color, physical state, odor and pH
  • Melting/boiling points
  • Density (liquids and solids)
  • Solubility (water and organic solvents)
  • Fat solubility
  • Dissociation constants in water
  • Partition coefficient (n-Octanol/water)
  • Stability to temperature, metals and metal ions
  • Oxidation/reduction and chemical incompatibility
  • Storage stability (accelerated and multi-year at various temperatures, including warehouse conditions)
  • Corrosion characteristics
  • Viscosity (rate, yield and viscosity curves)
  • Miscibility
  • Flammability/flashpoint/flame extension
  • Surface tension
  • UV/Visible absorption and spectral characterization (MS, IR, NMR)
  • Vapor pressure
  • CIPAC formulation properties