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Cetirizine Dihydrochloride IP-BP-EP



  • Synonyms of Cetirizine Dihydrochloride : Cetirizine Hydrochloride, 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


Specifications

Description A white or almost white crystalline powder.
Solubility Freely soluble in water, practically insoluble in acetone, and in methylene chloride.
Appearance of
Solution
5%solution is clear and not more intensely colored than reference solution BY7 .
Identifications 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%
Assay
( On Dried Basis )
99% to 100.5% w/w as
C21 H27O3N2Cl3.
Heavy Metals Not more than 10 ppm