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Cetirizine Dihydrochloride

Cetirizine Dihydrochloride

 



2-[4-[(4-Chlorophenyl)-phenylmethyl]-1-piperazinyl]ethoxyacetic acid

C21H25ClN2O3*2HCl             
Mol. Wt.: 461.82 
CAS 83881-52-1

Description
A white or almost-white powder

Medical Use/Therapeutic Category
Non-sedating antihistaminic

Solubility
- Freely soluble in water
- Slightly soluble in 2-propanol
- Practically insoluble in acetone or methylene chloride

Identification
A. Infrared spectrum:  Conforms to that of the reference standard
B. Chlorides:  Positive reaction of chlorides
C. HPLC

Characteristics of 5% W/V Solution
pH:  Between 1.2 and 1.8
Appearance:  Clear and not more colored than the BY7 reference

Chromatographic Purity (related substances)
Any unidentified compound:  Not more than 0.1%
Total impurities:  Not more than 0.3%

Assay
By titration:  99.0 – 100.5% (on dried basis)
By HPLC:  98.0 – 102.0% (on dried basis)

Other Tests
Water content:  Not more than 0.5%
Heavy metals:  Not more than 10 ppm
Sulfated ash:  Not more than 0.2%

Specifications and Analytical Methods – available upon request

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