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PREFORMULATION
Principal areas
Stability analysis
Physico-chemical
properties Solution stability
Bulk
Solubility analysis Solid state
Organoleptic characterization
Crystallinity and stability
properties Ionization constant pka
Particle size polymorphism Bulk stability
PH solubility profile
and shape Hygroscopicity Compatibility
Common ion effect
Purity Particle size
characterization Thermal effects
Surface
Bulk density Partition co-efficient
area
solubilization
Powder flow
Dissolution
properties
STABILITY
Solution phase
Solid-state of the drug alone
with the expected excipients
HPLC
Or TLC