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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 99.0 percent and not more than 100.5 percent of C10H9N4NaO2S, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers. Store at 25, excursions permitted between 15 and 30.
Identification—
A: Dissolve about 1.5 g in 25 mL of water, and add 3 mL of 6 N acetic acid: a white precipitate of sulfadiazine is formed. Collect the precipitate on a filter, wash it well with cold water, and dry at 105 for 1 hour: the sulfadiazine so obtained melts between 250 and 254 as determined by the method for Class Ia under Melting Range or Temperature 741, and responds to Identification test A under Sulfadiazine.
B: Ignite about 500 mg: the residue responds to the tests for Sodium 191.
Loss on drying 731— Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
Selenium 291: 0.003%, a 200-mg test specimen being used.
Heavy metals— Dissolve 1.0 g in 25 mL of water, and add 5 drops of sodium sulfide TS: any dark color produced is not darker than that in a blank to which 2 mL of Standard Lead Solution (see Heavy Metals 231) has been added (0.002%).
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Proceed with Sulfadiazine Sodium as directed under Nitrite Titration 451. Each mL of 0.1 M sodium nitrite is equivalent to 27.23 mg of C10H9N4NaO2S.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 2027
Pharmacopeial Forum : Volume No. 29(6) Page 1988
Phone Number : 1-301-816-8394