CETIRIZINE DIHYDROCHLORIDE

PRODUCT IDENTIFICATION

CAS NO. 83881-51-0 (Base)
83881-52-1 (Dihydrochloride)

CETIRIZINE DIHYDROCHLORIDE

EINECS NO.  
FORMULA C21H23ClN2O3·2HCl
MOL WT. 461.82

H.S. CODE

 

TOXICITY

 

SYNONYMS (1S.2S)-2-Methylamino-1-phenyl-1-propanol dichloride;
PRICE U$190/kg by air (for 10kgs quantity)
U$790.- by air (for 1kg quantity)

CLASSIFICATION

 

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE white to off-white crystalline powder
MELTING POINT  
BOILING POINT

 

SPECIFIC GRAVITY

 

SOLUBILITY IN WATER Soluble (Insoluble in acetone )
pH 1.2 - 1.8 (5% sol.)
VAPOR DENSITY

 

AUTOIGNITION

 

NFPA RATINGS

 

REFRACTIVE INDEX

 

FLASH POINT

 

STABILITY

Stable under ordinary conditions. Hygroscopic.

APPLICATIONS

Cetirizine is a selective H1-receptor antagonist used to treat allergic rhinitis and chronic idiopathic urticaria, and as a treatment adjunct in asthma. It is a racemic mixture of levo- and dextro-form, but levo-form is active. Chemically it is described as (1S.2S)-2-methylamino-1-phenyl-1-propanol. The hydrochloride salt of cetirizine is a white powder freely soluble in water, practically insoluble in acetone and dichloromethane; administered orally.
SALES SPECIFICATION

BIBLIOGRAPHY

EP2000

APPEARANCE

white to off-white crystalline powder

ASSAY

99.0 - 100.5% (on dry basis)
LOSS ON DRYING

0.5% max

SULFATED ASH

0.2% max

HEAVY METALS

10ppm max

INDIVIDUAL IMPURITY

0.2% max (total impurity: 0.3% max)

TRANSPORTATION
PACKING
 
HAZARD CLASS Not regulated
UN NO.  
OTHER INFORMATION