Sulfadiazine Sodium
C10H9N4NaO2S 272.26

Benzenesulfonamide,4-amino-N-2-pyrimidinyl-,monosodium salt.
N1-2-Pyrimidinylsulfanilamide monosodium salt [547-32-0].
»Sulfadiazine Sodium contains not less than 99.0percent and not more than 100.5percent of C10H9N4NaO2S,calculated on the dried basis.
Packaging and storage— Preserve in tight,light-resistant containers.Store at 25,excursions permitted between 15and 30.
Identification—
A: Dissolve about 1.5g in 25mLof water,and add 3mLof 6Nacetic acid:a white precipitate of sulfadiazine is formed.Collect the precipitate on a filter,wash it well with cold water,and dry at 105for 1hour:the sulfadiazine so obtained melts between 250and 254as determined by the method for Class Iaunder Melting Range or Temperature á741ñ,and responds to Identificationtest Aunder Sulfadiazine.
B: Ignite about 500mg:the residue responds to the tests for Sodium á191ñ.
Loss on drying á731ñ— Dry it at 105for 2hours:it loses not more than 0.5%of its weight.
Selenium á291ñ: 0.003%,a 200-mg test specimen being used.
Heavy metals— Dissolve 1.0g in 25mLof water,and add 5drops of sodium sulfide TS:any dark color produced is not darker than that in a blank to which 2mLof Standard Lead Solution(see Heavy Metals á231ñ)has been added (0.002%).
Assay— Proceed with Sulfadiazine Sodium as directed under Nitrite Titration á451ñ.Each mLof 0.1Msodium nitrite is equivalent to 27.23mg of C10H9N4NaO2S.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1822
Pharmacopeial Forum:Volume No.29(6)Page 1988
Phone Number:1-301-816-8394