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| BALSALAZIDE DISODIUM HYDRATE | ||
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PRODUCT IDENTIFICATION |
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| CAS NO. | 80573-04-2;
82101-18-6 (Base) 150399-21-6; 213594-60-6 (Disodium) |
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| EINECS NO. | ||
| FORMULA | C17H13N3O6Na2.2H2O | |
| MOL WT. | 437.32 | |
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H.S. CODE |
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TOXICITY |
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| SYNONYMS | Balsalazida; Balsalazide; Balsalazido; | |
| 5-((1E)-(4-(((2-carboxyethyl)amino)carbonyl)phenyl)azo)-2-hydroxybenzoic acid disodium salt hydrate; Balsalazidum; | ||
| DERIVATION |
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CLASSIFICATION |
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PHYSICAL AND CHEMICAL PROPERTIES |
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| PHYSICAL STATE | yellow to orange crystalline powder | |
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| BOILING POINT | ||
| SPECIFIC GRAVITY | ||
| SOLUBILITY IN WATER | freely soluble (soluble in methanol) | |
| pH | ||
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| AUTOIGNITION |
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REFRACTIVE INDEX |
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| FLASH POINT |
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| STABILITY |
Stable under ordinary conditions. Hygroscopic. |
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GENERAL DESCRIPTION & APPLICATIONS |
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| 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 | ||
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APPEARANCE |
yellow to orange crystalline powder | |
| IDENTIFICATION |
passes Test A,B |
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| ASSAY | 98.0 - 102.0% as dried basis | |
| WATER | 8.0
- 10.0% max |
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| CLARITY OF SOLUTION | Clear to amber solution | |
| TRANSPORTATION | ||
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| HAZARD CLASS | ||
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| OTHER INFORMATION | ||
| Hazard Symbols: XI, Risk Phrases: 36/36/38, Safety Phrases: 26-36 | ||
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