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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 237.5mg and not more than 262.5mg of C10H9N4NaO2S.
Packaging and storage—
Preserve in single-dose,light-resistant containers,of Type Iglass.
Identification—
It responds to Identificationtest Aunder Sulfadiazine Sodium.
Bacterial endotoxins á85ñ—
It contains not more than 0.1USP Endotoxin Unit per mg of sulfadiazine sodium.
pHá791ñ:
between 8.5and 10.5.
Particulate matter á788ñ:
meets the requirements under small-volume injections.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Pipet a volume of Injection,equivalent to about 500mg of sulfadiazine sodium,into a beaker or a casserole,and proceed as directed under Nitrite Titration á451ñ,beginning with “Add 20mLof hydrochloric acid.”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 1823
Phone Number:1-301-816-8394
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