Calcium Chloride

(kal' see um klor' ide).

CaCl2·2H2O147.01
Calcium chloride dihydrate

[10035-04-8].
CaCl2110.98
Anhydrous

[10043-52-4].

DEFINITION

Calcium Chloride contains an amount of CaCl2 equivalent to NLT 99.0% and NMT 107.0% of CaCl2·2H2O.

IDENTIFICATION

• A. Identification Tests—General, Calcium

191

Sample solution: 100 mg/mL

Acceptance criteria: Meets the requirements

• B. Identification Tests—General, Chloride

191

Sample solution: 100 mg/mL

Acceptance criteria: Meets the requirements

ASSAY

• Procedure

Sample solution: Dissolve 1 g of Calcium Chloride in a mixture of water and 3 N hydrochloric acid (100:5). Transfer the solution to a 250-mL volumetric flask, and dilute with water to volume.

Analysis: Pipet 50 mL of the Sample solution into a suitable container, and add 100 mL of water, 15 mL of 1 N sodium hydroxide, and 300 mg of hydroxy naphthol blue. 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 calcium chloride dihydrate (CaCl2·2H2O).

Acceptance criteria: 99.0%–107.0% of CaCl2·2H2O

IMPURITIES

• Aluminum

206

[Note—Perform if labeled as intended for use in hemodialysis. ]

Test preparation: Use a 2.0-g sample.

Acceptance criteria: NMT 1 ppm

• Heavy Metals

231

Sample solution: 80 mg/mL

Acceptance criteria: NMT 10 ppm

• Iron, Aluminum, and Phosphate

Sample solution: 50 mg/mL

Analysis: Add 2 drops of 3 N hydrochloric acid and 1 drop of phenolphthalein TS to the Sample solution. 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.

Acceptance criteria: No turbidity or precipitate is produced.

• Limit of Magnesium and Alkali Salts

Sample solution: 20 mg/mL

Analysis: To 50 mL of Sample solution add 500 mg of ammonium chloride. Heat the solution, and boil for 1 min. Rapidly add 40 mL of oxalic acid TS, and stir vigorously until precipitation is well established. Add immediately to the warm mixture 2 drops of methyl red TS and then 6 N ammonium hydroxide, dropwise, until the mixture is just alkaline. Cool to room temperature. Transfer to a 100-mL graduated cylinder, dilute with water to 100 mL, mix, and allow to stand for 4 h or overnight. Filter, and to 50 mL of the clear filtrate in a platinum dish, add 0.5 mL of sulfuric acid, and evaporate the mixture on a steam bath to a small volume. Carefully heat over a free flame to dryness, and continue heating to complete decomposition and volatilization of ammonium salts. Finally, ignite the residue to constant weight.

Acceptance criteria: The weight of the residue is NMT 5 mg (1.0%).

SPECIFIC TESTS

• pH

791

Sample solution: 50 mg/mL

Acceptance criteria: 4.5–9.2

ADDITIONAL REQUIREMENTS

• Packaging and Storage: Preserve in tight containers.

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

Auxiliary Information— Please check for your question in the FAQs before contacting USP.

Topic/Question	Contact	Expert Committee
Monograph	Domenick Vicchio, Ph.D. Senior Scientific Liaison 1-301-998-6828	(SM42010) Monographs - Small Molecules 4

USP35–NF30 Page 2450

Pharmacopeial Forum: Volume No. 29(5) Page 1436

Chromatographic Column—

CALCIUM CHLORIDE

Chromatographic columns text is not derived from, and not part of, USP 35 or NF 30.