Sodium Sulfate Injection
» Sodium Sulfate Injection is a sterile, concentrated solution of Sodium Sulfate in Water for Injection, which upon dilution is suitable for parenteral use. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of Na2SO4·10H2O.
Packaging and storage— Preserve in single-dose containers, preferably of Type I glass.
Labeling— Label it to indicate that it is to be diluted before injection to render it isotonic (3.89% of Na2SO4·10H2O).
Identification— It responds to the tests for Sodium 191 and for Sulfate 191.
Pyrogen— When diluted with water for injection to contain 3.89% of Na2SO4·10H2O, it meets the requirements of the Pyrogen Test 151.
pH 791: between 5.0 and 6.5.
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer an accurately measured volume of Injection, equivalent to about 400 mg of sodium sulfate (Na2SO4·10H2O), to a suitable vessel. Dilute if necessary, to 200 mL, and proceed as directed in the Assay under Sodium Sulfate, beginning with “add 1 mL of hydrochloric acid.” The weight of the barium sulfate so obtained, multiplied by 1.3804, represents its equivalent of Na2SO4·10H2O.
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Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Principal Scientific Liaison
(SM32010) Monographs - Small Molecules 3
USP35–NF30 Page 4671