Packaging and storage
Preserve in single-dose containers, preferably of Type I glass.
Labeling
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.
Identification
It responds to the tests for
Calcium and
Chloride 191.
pH 791:
between 5.5 and 7.5 in the undiluted Injection, except where the concentration is greater than 1 in 20, in which case this range applies to the Injection diluted with water to yield a concentration of 1 in 20.
Other requirements
It meets the requirements under
Injections 1.
Assay
Transfer an accurately measured volume of Injection, equivalent to about 1 g of calcium chloride, to a 250-mL volumetric flask, add 5 mL of 3 N hydrochloric acid, dilute with water to volume, and mix. Pipet 50 mL of the resulting solution into a suitable container, add 100 mL of water, 15 mL of 1 N sodium hydroxide, and 300 mg of hydroxy naphthol blue, and titrate with 0.05 M edetate disodium VS until the solution is deep blue. Each mL of 0.05 M edetate disodium is equivalent to 7.351 mg of CaCl2·2H2O.