Calcium Gluconate Injection
» Calcium Gluconate Injection is a sterile solution of Calcium Gluconate in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of total Ca. The calcium is in the form of calcium gluconate, except that a small amount may be replaced with an equal amount of calcium in the form of Calcium Saccharate, or other suitable calcium salts, for the purpose of stabilization. It may contain sodium hydroxide added for adjustment of the pH.
Injection intended for veterinary use only may be prepared from Calcium Gluconate solubilized with Boric Acid, or from Glyconolactone, Boric Acid, and Calcium Carbonate.
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
A: A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate.
B: A dilution of the Injection with water (1 in 5) responds to the tests for Calcium 191.
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.
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).
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USP35NF30 Page 2455Pharmacopeial Forum: Volume No. 27(6) Page 3258