Bupropion HCl

Antidepressant agent

Parameters Results
Name Bupropion HCl
Quality IP/BP/EP/USP
IUPAC Name 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one;hydrochloride
Molecular Formula C13H19Cl2NO
Molecular Weight 276.2 gm/mol
CAS Number 31677-93-7
Physical Appearance A white or almost white powder
Solubility Soluble in water, 0.1N HCl and in alcohol
Identification by
(A) IR Absorption
(B) HPLC test
(C) Chloride Test
Test A, B and C complies
Related Substance by HPLC
*Method I
3-chlorobenzoic acid
*Method II
Deschloro bupropion
Bupropion dione derivative
o-Bupropion
Chloropropiophenone
Bupropion HCl related compound A
Bupropion HCl related compound B
Bromochloropropiophenone
4-chlorobupropion
5-chlorobupropion
Any single impurity
Total impurity


Not more than 0.2%

Not more than 0.5%
Not more than 0.2%
Not more than 0.1%
Not more than 0.1%

Not more than 0.2%

Not more than 0.2%
Not more than 0.1%
Not more than 0.2%
Not more than 0.2%
Not more than 0.1%
Not more than 1.0%
Assay by HPLC 98.0% to 102% (on anhydrous basis)
Residual Solvents
Acetone
Acetonitrile
Dichloromethane
Toluene
Methanol
n-Hexane

Max 5000 ppm
Max 410 ppm
Max 600 ppm
Max 890 ppm
Max 3000 ppm
Max 290 ppm