Sulfisoxazole Acetyl
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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 98.0percent and not more than 100.5percent of C13H15N3O4S,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Ultraviolet Absorption á197Uñ—
Solution:
10µg per mL.
Medium:
alcohol.
Absorptivities at 290nm,calculated on the dried basis,do not differ by more than 3.0%.
Loss on drying á731ñ—
Dry it at 105
for 3hours:it loses not more than 0.5%of its weight.
for 3hours:it loses not more than 0.5%of its weight.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of toluene and acetone (1:1).
Visualization:
1.
Organic volatile impurities,Method IVá467ñ:
meets the requirements.
Other requirements—
It meets the requirements for Residue on ignition,Selenium,and Heavy metalsunder Sulfisoxazole.
Assay—
Transfer about 1g of Sulfisoxazole Acetyl,accurately weighed,to a 250-mLbeaker.Add 15mLof glacial acetic acid,swirl to dissolve,then add 25mLof hydrochloric acid and 80mLof water.Proceed as directed under Nitrite Titration á451ñ,beginning with “Cool to about 15.”Each mLof 0.1Msodium nitrite is equivalent to 30.94mg of C13H15N3O4S.
.”Each mLof 0.1Msodium nitrite is equivalent to 30.94mg of C13H15N3O4S.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1837
Phone Number:1-301-816-8394