Sulfadiazine Sodium Injection
» Sulfadiazine Sodium Injection is a sterile solution of Sulfadiazine Sodium in Water for Injection. It contains, in each mL, not less than 237.5 mg and not more than 262.5 mg of C10H9N4NaO2S.
Packaging and storage—
Preserve in single-dose, light-resistant containers, of Type I glass.
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Identification—
It responds to Identification test A under Sulfadiazine Sodium.
Bacterial endotoxins 
85
—
It contains not more than 0.1 USP Endotoxin Unit per mg of sulfadiazine sodium.
85—
It contains not more than 0.1 USP Endotoxin Unit per mg of sulfadiazine sodium.
pH 791:
between 8.5 and 10.5.
791:
between 8.5 and 10.5.
Particulate matter 788:
meets the requirements under small-volume injections.
788:
meets the requirements under small-volume injections.
Other requirements—
It meets the requirements under Injections 1.
1.
Assay—
Pipet a volume of Injection, equivalent to about 500 mg of sulfadiazine sodium, into a beaker or a casserole, and proceed as directed under Nitrite Titration 451, beginning with “Add 20 mL of hydrochloric acid.” Each mL of 0.1 M sodium nitrite is equivalent to 27.23 mg of C10H9N4NaO2S.
451, beginning with “Add 20 mL of hydrochloric acid.” 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 |
|
| 85 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 4709