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

Labeling— Label the Injection to indicate its content, if any, of added calcium salts, calculated as percentage of calcium in the Injection. 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. The labeling indicates that the Injection must be clear at the time of use, and that if crystallization has occurred, warming may redissolve the precipitate. Injection intended for veterinary use only is so labeled. If Injection contains Boric Acid, it is so labeled.

USP Reference standards 11— USP Endotoxin RS. USP Potassium Gluconate RS.

Identification—

Bacterial endotoxins 85— It contains not more than 0.17 USP Endotoxin Unit per mg of calcium gluconate.

pH 791: between 6.0 and 8.2, except that in the case where it is labeled as intended for veterinary use only and as containing boric acid, it is between 2.5 and 4.5.

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— To an accurately measured volume of Injection, equivalent to about 500 mg of calcium gluconate, add 2 mL of 3 N hydrochloric acid, and dilute with water to 150 mL. While stirring, preferably with a magnetic stirrer, add about 20 mL of 0.05 M edetate disodium VS from a 50-mL buret. Add 15 mL of 1 N sodium hydroxide and 300 mg of hydroxy naphthol blue, and continue the titration to a blue endpoint. Each mL of 0.05 M edetate disodium is equivalent to 2.004 mg of calcium (Ca).

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

USP29–NF24 Page 355

Phone Number : 1-301-816-8389