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

Labeling— The label states the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,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 á11ñ— USP Endotoxin RS.

Identification— It responds to the Identificationtests under Calcium Levulinate.

Bacterial endotoxins á85ñ— It contains not more than 35.70USP Endotoxin Units per mg of calcium levulinate.

pHá791ñ: between 6.0and 8.0.

Particulate matter á788ñ: meets the requirements for small-volume injections.

Other requirements— It meets the requirements under Injections á1ñ.

Assay— Transfer an accurately measured volume of Injection,equivalent to about 600mg of calcium levulinate,to a 400-mLbeaker,add 2mLof hydrochloric acid,and proceed as directed in the Assayunder Calcium Levulinate,beginning with “While stirring with a magnetic stirrer.”Each mLof 0.05Medetate disodium is equivalent to 15.32mg of C10H14CaO6·2H2O.

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

USP28–NF23Page 331

Phone Number:1-301-816-8389