Calcium Gluconate Injection
»Calcium Gluconate Injection is a sterile solution of Calcium Gluconate in Water for Injection.It contains not less than 95.0percent and not more than 105.0percent 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 Iglass.
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 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.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.
Identification—
A: Avolume of Injection diluted,if necessary,with water to obtain a test solution of calcium gluconate (1in 100)responds to Identification test Bunder Calcium Gluconate.
B: Adilution of the Injection with water (1in 5)responds to the tests for Calcium á191ñ.
Bacterial endotoxins á85ñ— It contains not more than 0.17USP Endotoxin Unit per mg of calcium gluconate.
pHá791ñ: between 6.0and 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 2.5and 4.5.
Particulate matter á788ñ: meets the requirements for small-volume injections.
Other requirements— It meets the requirements under Injections á1ñ.
Assay— To an accurately measured volume of Injection,equivalent to about 500mg of calcium gluconate,add 2mLof 3Nhydrochloric acid,and dilute with water to 150mL.While stirring,preferably with a magnetic stirrer,add about 20mLof 0.05Medetate disodium VSfrom a 50-mLburet.Add 15mLof 1Nsodium hydroxide and 300mg of hydroxy naphthol blue,and continue the titration to a blue endpoint.Each mLof 0.05Medetate disodium is equivalent to 2.004mg of calcium (Ca).
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(DSN)Dietary Supplements:Non-Botanicals
USP28–NF23Page 328
Pharmacopeial Forum:Volume No.27(6)Page 3258
Phone Number:1-301-816-8389