Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass.

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 á191ñand for Sulfate á191ñ.

Pyrogen— When diluted with water for injection to contain 3.89%of Na2SO4·10H2O,it meets the requirements of the Pyrogen Test á151ñ.

pHá791ñ: between 5.0and 6.5.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Transfer an accurately measured volume of Injection,equivalent to about 400mg of sodium sulfate (Na2SO4·10H2O),to a suitable vessel.Dilute if necessary,to 200mL,and proceed as directed in the Assayunder Sodium Sulfate,beginning with “add 1mLof hydrochloric acid.”The weight of the barium sulfate so obtained,multiplied by 1.3804,represents its equivalent of Na2SO4·10H2O.

Expert Committee:(PA4)Pharmaceutical Analysis 4

USP28–NF23Page 1794

Phone Number:1-301-816-8251