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— Asolution (1in 10)responds to the tests for Calcium á191ñand for Chloride á191ñ.

pHá791ñ: between 4.5and 9.2,in a solution (1in 20).

Aluminum á206ñ(where it is labeled as intended for use in hemodialysis)— Proceed as directed using 2.0g of Calcium Chloride to prepare the Test Preparation:the limit is 1µg per g.

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

Heavy metals á231ñ— Dissolve 2.0g in 25mLof water:the limit is 0.001%.

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

Organic volatile impurities,Method Iá467ñ: meets the requirements.

Assay— Transfer about 1g of Calcium Chloride,accurately weighed,to a 250-mLbeaker,and dissolve in a mixture of water and 3Nhydrochloric acid (100:5).Transfer the solution to a 250-mLvolumetric flask,dilute with water to volume,and mix.Pipet 50mLof the 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 in color.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