Sulfacetamide Sodium
C8H9N2NaO3S·H2O
254.24
Acetamide,N-[(4-aminophenyl)sulfonyl]-,monosodium salt,monohydrate.
N-Sulfanilylacetamide monosodium salt monohydrate [6209-17-2].
Anhydrous 236.23 [127-56-0].
»Sulfacetamide Sodium contains not less than 99.0percent and not more than 100.5percent of C8H9N2NaO3S,calculated on the anhydrous basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Dissolve about 1g in 25mLof water,adjust with 6Nacetic acid to a pHof between 4and 5,and filter.Wash the precipitate with water,and dry at 105
for 2hours:the sulfacetamide so obtained melts between 180and 184.
for 2hours:the sulfacetamide so obtained melts between 180and 184.
B:
Place about 500mg of the sulfacetamide obtained in Identificationtest Ain a test tube,and heat gently until it boils:an oily liquid,which has the characteristic odor of acetamide,condenses on the walls of the test tube (distinction from the sublimates of sulfadiazine,sulfamerazine,and sulfamethazine,which are solids at room temperature).
D:
Dissolve about 100mg in 5mLof water,and add 5drops of cupric sulfate TS:a light bluish green precipitate is formed,and it remains unchanged on standing.
E:
Dissolve about 500mg in 10mLof dilute hydrochloric acid (1in 10).To about one-half of the solution add 2mLof trinitrophenol TS:a very heavy flocculent or almost gelatinous precipitate is formed.To the remainder of the solution add 3drops of formaldehyde TS:a white precipitate is formed,and it changes to orange on standing (distinction from sulfamethoxypyridazine).
pHá791ñ:
between 8.0and 9.5,in a solution (1in 20).
Water,Method Iá921ñ:
not more than 8.1%.
Selenium á291ñ:
0.003%,a 200-mg test specimen being used.
Heavy metals—
Dissolve 1.0g in 25mLof water,and add 5drops of freshly prepared sodium sulfide TS:any color produced is not darker than that of a control made with 25mLof water,2.0mLof Standard Lead Solution(see Heavy Metals á231ñ),and 5drops of sodium sulfide TS(0.002%).
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of ethyl acetate,methanol,and ammonium hydroxide (17:6:5).
Visualization:
1.
Assay—
Proceed with Sulfacetamide Sodium as directed under Nitrite Titration á451ñ.Each mLof 0.1Msodium nitrite is equivalent to 23.62mg of C8H9N2NaO3S.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1816
Phone Number:1-301-816-8394