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Escitalopram Oxalate

Uses: Escitalopram is used to treat depression and anxiety. It works by helping to restore the balance of a certain natural substance (serotonin) in the brain. Escitalopram belongs to a class of drugs known as selective serotonin reuptake inhibitors (SSRI)
UN No:
Molecular Formula:
C20H21FN2O *C2H2O4
Molecular Weight:
414.40 g/mol


Sr. No. Test Limits
1 Description Fine, white to slightly yellow crystalline powder
2 Solubility Freely soluble in Methanol and Dimethylsulfoxide,
sparingly soluble in Water and in Alcohol, Very
slightly soluble in Ethyl acetate and Isopropyl
alcohol, insoluble in HeptaneNMT 3.0%
3 Identification
a. By FTIR The infrared absorption spectrum of the
sample preparation should be concordant with
that of the infrared absorption spectrum of
standard preparation
b. By HPLC In the test for Assay, the retention time
of the principal peak as obtained in the
chromatogram of sample should correspond to
that obtained in the chromatogram of standard
c. Test for Oxalate It should comply with the test
4 Water by KF (%, w/w) Not more than 1.0
5 Residue on Ignition (%, w/w) Not more than 0.1
6 Heavy Metals (ppm) Not more than 0.1
7 Enantiomeric Purity by HPLC (%,w/w) Not more than 3.0
8 Related Substances by HPLC (%, w/w)
5-Dimethylaminobutyryl Citalopram Not more than 0.2
Citalopram related compound A Not more than 0.1
Citalopram related compound B Not more than 0.1
Citalopram related compound C Not more than 0.1
Citalopram related compound D Not more than 0.1
Citalopram related compound E Not more than 0.1
Individual unspecified impurity Not more than 0.1
Total impurities Not more than 0.5
9 Assay by HPLC (%, w/w),(As“
On anhydrous basis)
Not more than 0.5