Cetirizine Dihydrochloride IP-BP-EP

Cetirizine Dihydrochloride IP-BP-EP

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Synonyms of Cetirizine Dihydrochloride: Cetirizine, 2[2-[4-[(4-Chlorophenyl) Phenyl Methyl]-1-Piperazinyl]Ethoxy ] Acetic Acid Dihydrochloride.

  • Formula of Cetirizine Dihydrochloride : C21H25ClN2O3 . 2HCl
  • CAS of Cetirizine Dihydrochloride : 83881-52-1
  • Uses of Cetirizine Dihydrochloride : Anti histamine, Anti allergic
  • Specification of Cetirizine Dihydrochloride : As per IP/BP/EP
  • Molecular weight : 461.8
  • CAS Number : 83881-52-1
  • Chemical Name [IUPAC Name]:
    (RS)-2-[2-[4-[(4-Chlorophenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic acid dihydrochloride.

Impurity Profile of Cetirizine Dihydrochloride

  • Impurity A,B,C,D,E,F: Not More than 0.1%
  • Individual Unknown Impurity: Not More than 0.1%
  • Total Impurity: Not More than 0.3%



A white or almost white crystalline powder.


Freely soluble in water, practically insoluble in acetone, and in methylene chloride.

Appearance of

5%solution is clear and not more intensely colored than reference solution BY7 .


Test A,B,C & D as per IP/BP/EP/USP

PH(1 gm in 20 ml water)

1.2 to 1.8

Loss On Drying

Not more than 0.5% w/w.

Sulphated Ash

Not more than 0.2% w/w.

Related Substance
( By HPLC )

Any Individual Impurity : NMT 0.1%
Impurity A : NMT 0.1%
Impurity B : NMT 0.1%
Impurity C : NMT 0.1%
Impurity D : NMT 0.1%
Impurity E : NMT 0.1%
Impurity F : NMT 0.1%
Total Impurity : NMT 0.3%

( On Dried Basis )

99% to 100.5% w/w as
C21 H27O3N2Cl3.

Heavy Metals

Not more than 10 ppm