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.

Residual solvents 467: meets the requirements.

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.

Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine

USP29–NF24 Page 1992

Phone Number : 1-301-816-8251