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 tests for Calcium and Chloride á191ñ.

Bacterial endotoxins á85ñ— It contains not more than 0.2USP Endotoxin Unit per mg of calcium chloride.

pHá791ñ: between 5.5and 7.5in the undiluted Injection,except where the concentration is greater than 1in 20,in which case this range applies to the Injection diluted with water to yield a concentration of 1in 20.

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 1g of calcium chloride,to a 250-mLvolumetric flask,add 5mLof 3Nhydrochloric acid,dilute with water to volume,and mix.Pipet 50mLof the resulting solution into a suitable container,add 100mLof water,15mLof 1Nsodium hydroxide,and 300mg of hydroxy naphthol blue,and titrate with 0.05Medetate disodium VSuntil the solution is deep blue.Each mLof 0.05Medetate disodium is equivalent to 7.351mg of CaCl2·2H2O.

Expert Committee:(PA1)Pharmaceutical Analysis 1

USP28–NF23Page 324

Phone Number:1-301-816-8379