Aripiprazole

Aripiprazole

General Properties and Specifications of Aripiprazole:
Appearance: White to off-white, crystalline powder.
Assay: Between 98% and 102%
Identifications: By IR and by HPLC.
Loss on drying: 0.5% maximum.
Residue on ignition: 0.1% maximum.
Related inpurities:
Aripiprazole related compound G: 0.1% maximum.
Aripiprazole related compound F: 0.1% maximum.
Aripiprazole 4,4’ dimer: 0.1% maximum.
Any other individual impurity: 0.1% maximum.
Total impurities: 0.5% maximum.
Residual solvents:
Methanol: 1000 ppm maximum.
Isopropyl alcohol: 1000 ppm maximum.
Acetonitrile: 300 ppm maximum.
N-Hexane: 200 ppm maximum.
Tetrahydrofurane: 600 ppm maximum.
Triethylamine: 320 ppm maximum.
Relative Density: about 1.3
Melting Point: 137C to 140C literature.
Boiling Point: 646C.
Solubility: Freely soluble in dichloromethane. Sparingly soluble in toluene. Insoluble in methanol and water.
Storage: Preferably 2C to 8C. OK to freeze. Protected from light.