Chemical Testing

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  • FIVE BATCH ANALYSIS
    • Pre-screening of 5-batches for impurities including 3D screening
    • Impurity identification and structure elucidation in consultation with the sponsor
    • GLP analysis of 5-batches using validated analytical methods for active ingredient content and impurities
    • Characterization of 5 commercial batches along with reference standards by various characterization methods as applicable
  • PHYSICAL AND CHEMICAL PROPERTIES OF TECHNICAL GRADE ACTIVE INGREDIENTS (TGAIS)
    • Active ingredient content (including method development and validation)
    • Color, odor and physical state
    • UV-VIS absorption spectra
    • Melting point & Boiling point
    • Water solubility
    • Solubility in six organic solvents
    • Dissociation constant(s)
    • Hydrolysis as a function of pH
    • Partition coefficient
    • Vapour pressure
    • Relative density/density/specific gravity
    • Accelerated storage stability
    • Flammability (solids)
    • pH
    • Moisture content
    • Loss on drying
    • Oxidation/reduction: Chemical incompatibility
    • Corrosivity
    • Long-term storage stability with corrosion characteristics
    • Aqueous direct photolysis
    • Surface tension
    • Explosive properties
    • Acidity/alkalinity
    • Oxidizing properties
    • Storage stability reports
  • PHYSICAL AND CHEMICAL PROPERTIES OF FORMULATED PRODUCTS
    • Active ingredient content
    • Appearance
    • Explosive properties
    • Flash point
    • Relative self-ignition
    • Oxidizing properties
    • Flammability
    • Acidity/Alkalinity/pH
    • Relative density/density/specific gravity
    • Bulk density
    • Wet sieve
    • Dust content
    • Friability & attrition characteristics
    • Friability & attrition characteristics
    • Flowability
    • Packaging stability
    • Suspensibility
    • Persistent foam
    • Emulsion properties
    • Wettability
    • Degree of dispersion
    • Dispersion stability
    • Corrosivity
    • Viscosity
    • Surface tension
    • Spontaneity of dispersion
    • Pourability
    • Low temperature stability
    • Dilution stability
    • Dissolution rate of water soluble bags
    • Spontaneity of dispersion
    • Pourability
    • Low temperature stability
    • Dilution stability
    • Dissolution rate of water soluble bags