Sulfisoxazole Acetyl
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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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.
USP REFERENCE STANDARDS 〈11〉—
USP Sulfisoxazole Acetyl RS
Identification—
Change to read:
A: Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy : 197K (CN 1-May-2020)
Change to read:
B: Spectroscopic Identification Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020) — 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.
Other requirements—It meets the requirements for Residue on ignition, and Selenium 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.
