Formulation Services

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