API/DS characterization

  • Solubility test – aqueous solutions and solvents
  • Stability testing – pH stability, solid stability, solution stability
  • Particle size distribution
  • Flowability and density (bulk and tap)
  • Melting point,
  • Morphology
  • Intrinsic dissolution


Pre-formulation study

  • pH-solubility profile
  • pH-stability profile
  • Forced degradation – acid, base, light, peroxide, heat
  • Method development and verification/validation
  • Excipients compatibility study


Finished product testing for solid oral dosage forms – tablets and capsules

  • Tablet hardness
  • Tablet friability
  • Tablet / capsule dissolution – apparatus I or II, with autosampling
  • Assay and impurities testing
  • Method development for assay/impurity and dissolution

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