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Cetirizine Dihydrochloride IP-BP-EP

Cetirizine Dihydrochloride IP-BP-EP

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For more than seven years we are one of the well-known manufacturers and suppliers of Cetirizine Dihydrochloride IP-BP-EP in India. We offer a quality range of Cetirizine Dihydrochloride IP-BP-EP to our clients from different verticals by meeting international quality standards. We process this product using high quality raw materials, which is sourced from our vendors at best price. Further, our company possess skilled professionals, who check the quality from the start by procuring of raw materials till it reaches the clients destination.

Specifications:

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%

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