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(API (Crystallization Process (Different Solvent for Crystallization…
API
Crystallization Process
Different Solvent for Crystallization
Hydrophobic Solvents
Hydrophilic Solvents
Reactive Precipitation
Seeding
PSD
By Milling
Wet
Dry
Micronisation
Jet Mill
Ball Mill
By Virtue
API Scale
DMF filed
Validation Completed
Consistent quality [Amorphous ratio/PSD]
Process
Crystaline Amorphous ratio
BET surface area
Alternate Polymorphic Forms
DT
DT Pattern
Erosion
Swelling
Crumble
pH 2
DT apparatus
Disso Apparatus
Water
Disso Apparatus
DT apparatus
API PSD
Process
Method of API extraction from formulation
Sonication Time
No of Frames
No of particles counted
Interference from other excipients
No of internal validation formulation used
Method
Malvern
Hot Stage
Raman
Solubility
pH
1
2
4.5
6.5
FeSSIF
Methodology
Kinetic
Saturation
Intrinsic
pH of Tablet