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Laboratory

Chemical Testing

FIVE BATCH ANALYSIS

  • Preliminary screening of five batches for impurities, including 3D assessment.

  • Identification of impurities and elucidation of structures in collaboration with the sponsor.

  • GLP-compliant analysis of five batches using validated analytical methods to determine active ingredient content and impurities.

  • Characterization of five commercial batches alongside reference standards using applicable characterization techniques.

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

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