Sulfacetamide
»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).
Melting range,Class Iá741ñ:
between 181and 184.
Reaction
Asolution (1in 150)is acid to litmus.
Loss on drying á731ñ
Dry it at 105for 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%).
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
USP28NF23Page 1815
Phone Number:1-301-816-8394
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