BALSALAZIDE DISODIUM HYDRATE

PRODUCT IDENTIFICATION

CAS NO. 80573-04-2; 82101-18-6 (Base)
150399-21-6; 213594-60-6 (Disodium)

BALSALAZIDE

EINECS NO.  
FORMULA C17H13N3O6Na2.2H2O
MOL WT. 437.32

H.S. CODE

 

TOXICITY

 

SYNONYMS Balsalazida; Balsalazide; Balsalazido;
5-((1E)-(4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoic acid disodium salt hydrate; Balsalazidum;
DERIVATION

 

CLASSIFICATION

 

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE yellow to orange crystalline powder
MELTING POINT

 

BOILING POINT  
SPECIFIC GRAVITY  
SOLUBILITY IN WATER freely soluble (soluble in methanol)
pH  
VAPOR DENSITY

 

AUTOIGNITION

 

NFPA RATINGS

 

REFRACTIVE INDEX

 
FLASH POINT

 

STABILITY

Stable under ordinary conditions. Hygroscopic.

GENERAL DESCRIPTION & APPLICATIONS

Balsalazide disodium liberates 5-aminosalicylic acid in colonic lumen by enzymatic action for colitis therapy. It is a prodrug of mesalamine (5-aminosalicylic acid) which is an anti-inflammatory drug used to treat inflammation of inflammatory bowel disease and mild to moderate ulcerative colitis which leads to flare-ups (bouts or attacks) of bloody diarrhea, abdominal cramps, and fever. Balsalazide is designed to release 5-aminosalicylic acid linked by an azo bond in the molecule. 5-Aminosalicylic acid is the active moiety of sulfasalazine, used to treat inflammation of the rectum and lower colon, mild to moderate ulcerative colitis proctosigmoiditis, and proctitis. 5-Aminosalicylic acid also known as a free radical antioxidant as well. Balsalazide disodium is believed to be the delivery of the active agent past the small intestine to the large intestine, the active site of ulcerative colitis. Olsalazine is an analogue of balsalazide which liberates 5-aminosalicylic acid. Olsalazine is a salicylate compound which two salicylate molecules are linked together by an azo bond. Balsalazide disodium is a yellow to orange powder; freely soluble in water and soluble in methanol but and practically insoluble in all other organic solvents. The chemical name 5-((1E)-(4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoic acid disodium salt.
SALES SPECIFICATION

APPEARANCE

yellow to orange crystalline powder
IDENTIFICATION

passes Test A,B

ASSAY 98.0 - 102.0% as dried basis
WATER
8.0 - 10.0% max
CLARITY OF SOLUTION Clear to amber solution
TRANSPORTATION
PACKING
 
HAZARD CLASS  
UN NO.  
OTHER INFORMATION
Hazard Symbols: XI, Risk Phrases: 36/36/38, Safety Phrases: 26-36