1. Stability Analysis
1.1. Accelerated stability
1.1.1. A method by which a product is exposed to elevated temperature simulating what would happen over longer periods on the shelf life.
1.2. Solution stability
1.2.1. Solution stability investigations commence with experiments to confirm decay at the extremes of pH and temperature
1.3. Solid state stability
1.4. Compatibility study
2. Bulk Characterization
2.1. Organoleptic properties
2.1.1. Organoleptic properties are those properties which are evaluated after impression on the organs of sense.
2.1.1.1. Color
2.1.1.2. Odor and Taste
2.2. Purity
2.2.1. Melting Point
2.2.2. MOLAR HEAT OF FUSION (ΔHf)
2.2.3. Impurity Index II
2.2.3.1. II = response of impurity/total response
2.2.4. Homogeneity Index HI
2.2.4.1. HI = response of pure sub./total response
2.2.5. USP Impurity Index (TLC)
2.3. Crystallinity & polymorphism
2.3.1. Crystal habit
2.3.2. Internal structure
2.3.2.1. Crystalline
2.3.2.2. Amorphous
2.3.2.2.1. Polymorphism
2.3.2.3. Amorphous
2.4. Hygroscopicity.
2.4.1. the measurement of a material's ability to absorb or release water as a function of humidity
2.4.1.1. Hygroscopic
2.4.1.2. Efflorescent
2.4.1.3. Deliquescent
2.4.1.4. desiccant
2.5. Particle characterization
2.5.1. Optical Microscopy
2.5.2. Optical Microscopy
2.5.3. Sedimentation
2.5.4. Coulter Counter
2.5.5. Determination of Surface Area
2.5.6. Laser Diffraction Analyzer (Zetasizer)
2.5.7. Scanning Electron Microscope
2.6. Bulk density
2.7. Powder flow properties
2.7.1. Angle of repose:
2.7.1.1. ≤25 excellent 25-30 good 30-40 passable ≥40 very poor
2.7.2. Bulk density measurements
2.7.2.1. Carr’s index
2.7.2.1.1. 5-15 excellent 12-16 good 18-21 passable 23-35 poor
2.7.2.2. Hausner ratio
2.7.2.2.1. 1.25 good flow >1.25 poor flow
3. Solubility Analysis
3.1. Ionization constant
3.1.1. determines the solubility in pH-dependent environment and extent of ionization
3.2. pH solubility profile
3.3. Solubilization
3.3.1. employs a saturated solution of the substance
3.4. Partition coefficient
3.4.1. measurement of a drug lipophilicity and its ability to cross cell membrane
3.4.1.1. log Po/w = log (Coil / Cwater) equilibrium