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

Labeling— The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol per mL.

USP Reference standards 11— USP Endotoxin RS.

Identification— It responds to the Identification tests under Calcium Levulinate.

Bacterial endotoxins 85— It contains not more than 35.70 USP Endotoxin Units per mg of calcium levulinate.

pH 791: between 6.0 and 8.0.

Particulate matter 788: meets the requirements for small-volume injections.

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 600 mg of calcium levulinate, to a 400-mL beaker, add 2 mL of hydrochloric acid, and proceed as directed in the Assay under Calcium Levulinate, beginning with “While stirring with a magnetic stirrer.” Each mL of 0.05 M edetate disodium is equivalent to 15.32 mg of C10H14CaO6·2H2O.

Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals

USP29–NF24 Page 358

Phone Number : 1-301-816-8389