Sulfadiazine Sodium
(sul'' fa dye' a zeen soe' dee um).
C10H9N4NaO2S
272.26
272.26Benzenesulfonamide, 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.
, excursions permitted between 15 and 30.
USP Reference standards 
11
—
11—
USP Sulfadiazine RS 
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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.
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.
191.
Loss on drying 731—
Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
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.
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%).
231) has been added (0.002%).
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.
451. Each mL of 0.1 M sodium nitrite is equivalent to 27.23 mg of C10H9N4NaO2S.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Leonel M. Santos, Ph.D.
Senior Scientific Liaison 1-301-816-8168 |
(SM12010) Monographs - Small Molecules 1 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4709
Pharmacopeial Forum: Volume No. 29(6) Page 1988