|
FLUOXETINE HYDROCHLORIDE USP
Fluoxetine Hydrochloride is Benzenepropanmine, N-methyl- -[4-(trifluoromethyl)phenoxy]-,hydrochloride
Formula: C17H18F3NO,HCl Category: Antidepressant.
Mol. Wt.: 345.79
|
Analysis
|
Specification
|
|
Description
|
White to off-white Crystalline Powder
|
|
Solubility
|
Sparingly soluble in water and in dichloromethane, freely soluble in alcohol and in methanol.
Practically insoluble in ether.
|
|
Identification:
A:
B:
|
By infra-red absorption spectrum
Gives the reactions of chlorides,
|
|
Water
|
Not More than 0.5 %
|
|
Heavy Metals
|
Not more than 0.003 %
|
|
Sulphated Ash
|
Not more than 0.1%
|
|
Related Compound
|
Total impurities NMT 0.5 %
|
|
Organic Volatile Impurity
|
To Comply the test
|
|
Assay
|
Fluoxetine Hydrochloride contains not less than 98.0 per cent and not more than 102.0 per cent of : C17H18F3NO,HCl, calculated on the anhydrous basis.
|
|
