Sulfacetamide
;)
Acetamide,N-[(4-aminophenyl)sulfonyl]-.
N-Sulfanilylacetamide [144-80-9].
»Sulfacetamide contains not less than 99.0percent and not more than 100.5percent of C8H10N2O3S,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Clarity and color of solution—
Dissolve about 200mg in 5mLof 1Nsodium hydroxide:a yellow to faintly yellow solution having not more than a trace of turbidity is produced.
Identification—
A:
Infrared Absorption á197Kñ.
B:
Place about 500mg in a test tube,heat gently until it boils,and cool: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,sulfamethazine,and sulfapyrazine,which are solids at room temperature).
Reaction—
Asolution (1in 150)is acid to litmus.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Sulfate á221ñ—
Digest 1g with 50mLof water at about 70for 5minutes.Cool immediately to room temperature,and filter.A25-mLportion of the filtrate so obtained shows no more sulfate than corresponds to 0.2mLof 0.02Nsulfuric acid (0.04%).
for 5minutes.Cool immediately to room temperature,and filter.A25-mLportion of the filtrate so obtained shows no more sulfate than corresponds to 0.2mLof 0.02Nsulfuric acid (0.04%).
Selenium á291ñ:
0.003%,a 200-mg test specimen being used.
Heavy metals,Method IIá231ñ:
0.002%.
Assay—
Proceed with Sulfacetamide as directed under Nitrite Titration á451ñ.Each mLof 0.1Msodium nitrite is equivalent to 21.42mg of C8H10N2O3S.
Auxiliary Information—
Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1815
Phone Number:1-301-816-8394