Levocetirizine Dihydrochloride

Selective H1 Antihistamine agent

Parameters Results
Name Levocetirizine DiHCl
Quality USP/IP/IH
IUPAC Name (R)-(2-(4-((4-Chlorophenyl)phenylmethyl)-1-piperazinyl) ethoxy)acetic acid dichloride
Molecular Formula C21H25ClN2O3.2HCl
Molecular Weight 461.82 gm/mol
CAS Number 130018-87-0
Physical Appearance A White or almost white Powder
Solubility Freely soluble in water, practically insoluble in Acetone
Appearance of Solution 5% solution is clear and not more intensely colored than reference solution BY7
Identification by IR Absorption The absorption maxima in the spectrum obtained with the sample should correspond in position and relative intensity to those in the spectrum obtained with that of standard.
Identification by HPLC The retention of the major peak in the Chromatogram of the assay preparation corresponds to that in the chromatogram of the standard preparation as obtained in the assay.
Identification by Sulphate Test It responds to the test of Sulphate.
pH (1 gm in 20 ml water) 1.2 to 1.8
Loss on Drying Not more than 0.5% w/w
Residue on Ignition Not more than 0.1% w/w
Enantiometric purity Not more than 1.0% w/w
Organic Impurities (By HPLC)
Chlorobenzhydryl piperazine
Levocetirizine amide
Any indivudual impurity
Total impurity

Not more than 0.1%
Not more than 0.1%
Not more than 0.1%
Not more than 0.4%
Heavy metals Not more than 20 ppm
Assay (on dry basis) 98% to 102% w/w as C21H25ClN2O3.2HCl