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Sulfisoxazole Acetyl
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C13H15N3O4S 309.34

Acetamide, N-[(4-aminophenyl)sulfonyl]-N-(3,4-dimethyl-5-isoxazolyl)-.
N-(3,4-Dimethyl-5-isoxazolyl)-N-sulfanilylacetamide [80-74-0].
» Sulfisoxazole Acetyl contains not less than 98.0 percent and not more than 100.5 percent of C13H15N3O4S, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
B: Ultraviolet Absorption 197U—
Solution: 10 µg per mL.
Medium: alcohol.
Absorptivities at 290 nm, calculated on the dried basis, do not differ by more than 3.0%.
Melting range 741: between 192 and 195.
Loss on drying 731— Dry it at 105 for 3 hours: it loses not more than 0.5% of its weight.
Ordinary impurities 466—
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of toluene and acetone (1:1).
Visualization: 1.
Organic volatile impurities, Method IV 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Residue on ignition, Selenium, and Heavy metals under Sulfisoxazole.
Assay— Transfer about 1 g of Sulfisoxazole Acetyl, accurately weighed, to a 250-mL beaker. Add 15 mL of glacial acetic acid, swirl to dissolve, then add 25 mL of hydrochloric acid and 80 mL of water. Proceed as directed under Nitrite Titration 451, beginning with “Cool to about 15.” Each mL of 0.1 M sodium nitrite is equivalent to 30.94 mg of C13H15N3O4S.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 2043
Phone Number : 1-301-816-8394