Uses:
Escitalopram oxalate is the active isomer of citalopram (S-citalopram), which has a highly selective inhibitory effect on the reuptake of serotonin (5-HT) and has little effect on the reuptake of norepinephrine and dopamine. It produces an antidepressant effect by increasing the concentration of 5-HT in the synaptic cleft by inhibiting 5-HT reuptake. It is mainly used for the treatment of major depressive disorder.
Items
Standard
Appearance
White to light
yellow powder.
Identification A
The IR spectrum conforms to that of Escitalopram Oxalate CRS.
Identification B
The retention time of major peak of sample solution corresponds to
that of the standard solution, as obtained in the Assay.
Residue on ignition
NMT 0.1%
Enantiomers
NMT 3.0%
Related substances
5-Dimethylaminobutyryl citalopram NMT 0.2%;
Citalopram Related compound A NMT 0.1%;
Citalopram Related compound B NMT 0.1%;
Citalopram Related compound C NMT 0.1%;
Citalopram Related compound D NMT 0.1%;
Citalopram Related compound E NMT 0.1%;
Any other individual unspecified impurity NMT 0.1%; Total impurities
NMT 0.5%
Residual solvents
Toluene ≤ 0.089%; Ethanol ≤ 0.5%;Isopropanol≤0.5%
Water
NMT 1.0%
Assay
98.0%~102.0% calculated on the anhydrous basis.
Less ...