CaCl2·2H2O 147.01

Calcium chloride, dihydrate.

Calcium chloride dihydrate [10035-04-8].

Anhydrous 110.98 [10043-52-4].

Packaging and storage— Preserve in tight containers.

Labeling— Where Calcium Chloride is intended for use in hemodialysis, it is so labeled.

Identification— A solution (1 in 10) responds to the tests for Calcium 191 and for Chloride 191.

pH 791: between 4.5 and 9.2, in a solution (1 in 20).

Aluminum 206 (where it is labeled as intended for use in hemodialysis)— Proceed as directed using 2.0 g of Calcium Chloride to prepare the Test Preparation: the limit is 1 µg per g.

Iron, aluminum, and phosphate— To a solution (1 in 20) add 2 drops of 3 N hydrochloric acid and 1 drop of phenolphthalein TS. Then add ammonium chloride–ammonium hydroxide TS, dropwise, until the solution is faintly pink, add 2 drops in excess, and heat the liquid to boiling: no turbidity or precipitate is produced.

Heavy metals 231— Dissolve 2.0 g in 25 mL of water: the limit is 0.001%.

Limit of magnesium and alkali salts— Dissolve 1 g in about 50 mL of water, add 500 mg of ammonium chloride, and proceed as directed in the test for Limit of magnesium and alkali salts under Calcium Carbonate, beginning with “heat the solution, and boil for 1 minute”: the weight of the residue does not exceed 5 mg (1.0%).

Organic volatile impurities, Method I 467: meets the requirements.

Residual solvents 467: meets the requirements.

Assay— Transfer about 1 g of Calcium Chloride, accurately weighed, to a 250-mL beaker, and dissolve in a mixture of water and 3 N hydrochloric acid (100:5). Transfer the solution to a 250-mL volumetric flask, dilute with water to volume, and mix. Pipet 50 mL of the 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 in color. Each mL of 0.05 M edetate disodium is equivalent to 7.351 mg of CaCl2·2H2O.

Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids

USP29–NF24 Page 351

Phone Number : 1-301-816-8143