U.S. PHARMACOPEIA

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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.
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.
pH 791: between 8.5 and 10.5.
Particulate matter 788: meets the requirements under small-volume injections.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 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.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 2027
Phone Number : 1-301-816-8394