Magnesium Chloride

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Magnesium Chloride contains NLT 98.0% and NMT 101.0% of MgCl₂ · 6H₂O.

2 IDENTIFICATION

A. Identification Tests—General, Magnesium〈191〉

Sample solution: 50 mg/mL

B. Identification Tests—General, Chloride〈191〉

Sample solution: 50 mg/mL

[Note—Acidify the Sample solution with diluted nitric acid before adding 6 N ammonium hydroxide.]

3 ASSAY

Procedure

Sample: 450 mg

Analysis: Dissolve the Sample in 25 mL of water, add 5 mL of ammonia–ammonium chloride buffer TS and 0.1 mL of eriochrome black TS, and titrate with 0.05 M edetate disodium VS to a blue endpoint. Each mL of 0.05 M disodium edetate is equivalent to 10.17 mg of MgCl₂ · 6H₂O.

Acceptance criteria: 98.0%–101.0%

4 IMPURITIES

Insoluble Matter

Sample: 20 g

Analysis: Dissolve the Sample in 200 mL of water, heat to boiling, and digest in a covered beaker on a steam bath for 1 h. Filter through a tared filtering crucible, wash thoroughly, dry at 115°, and determine the weight of the residue.

Acceptance criteria: NMT 0.005%

Chloride and Sulfate, Sulfate〈221〉

Sample: 10 g

Acceptance criteria: It shows no more sulfate than corresponds to 0.50 mL of 0.020 N sulfuric acid (0.005%).

Barium

Sample: 1 g

Analysis: Dissolve the Sample in 10 mL of water, and add 1 mL of 2 N sulfuric acid.

Acceptance criteria: No turbidity is produced within 2 h.

Limit of Calcium

[Note—A commercially available atomic absorption standard solution for calcium may be used where preparation of a calcium standard stock solution is described below. Concentrations of the Standard solutions and the Sample solution may be modified to fit the linear or working range of the instrument.]

Dilute hydrochloric acid: Dilute 100 mL of hydrochloric acid with water to 1000 mL.

Lanthanum solution: To 58.65 g of lanthanum oxide add 400 mL of water, and add, gradually with stirring, 250 mL of hydrochloric acid. Stir until dissolved, and dilute with water to 1000 mL.

Standard solutions: Transfer 249.7 mg of calcium carbonate, previously dried at 300° for 3 h and cooled in a desiccator for 2 h, to a 100-mL volumetric flask. Dissolve in a minimum amount of hydrochloric acid, and dilute with water to volume. Transfer 1.0, 5.0, 10.0, and 15.0 mL of this stock solution to separate 1000-mL volumetric flasks, each containing 20 mL of Lanthanum solution and 40 mL of Dilute hydrochloric acid. Dilute with water to volume. These Standard solutions contain 1.0, 5.0, 10.0, and 15.0 μg/mL of calcium, respectively.

Blank solution: Transfer 4 mL of Lanthanum solution and 10 mL of Dilute hydrochloric acid to a 200-mL volumetric flask, and dilute with water to volume.

Sample solution: Transfer 10.0 g of Magnesium Chloride to a 200-mL volumetric flask, and add water to dissolve. Add 4 mL of Lanthanum solution, and dilute with water to volume.

Instrumental conditions

(See Atomic Absorption Spectroscopy 〈852〉.)

Mode: Atomic absorption spectrophotometry

Lamp: Calcium hollow-cathode

Flame: Nitrous oxide–acetylene

Analytical wavelength: Calcium emission line at 422.7 nm

Analysis

Samples: Standard solutions, Blank solution, and Sample solution.

Determine the concentration, C, in μg/mL, of calcium in the Sample solution using the calibration graph.

Calculate the percentage of calcium in the portion of Magnesium Chloride taken:

Result = (V/W × C × F) × 100

V = volume of the Sample solution (mL)

W = weight of Magnesium Chloride taken (mg)

C = as defined above

F = conversion factor from μg/mL to mg/mL, 0.001

Acceptance criteria: NMT 0.01%

Potassium

Sample solution: 5 g

Analysis: Dissolve the Sample in 5 mL of water, and add 0.2 mL of sodium bitartrate TS.

Acceptance criteria: No turbidity is produced within 5 min.

Change to read:

Aluminum 〈206〉, Procedure 1 (CN 1-Jun-2023) (where it is labeled as intended for use in hemodialysis)

Test preparation: Prepare as directed in the chapter, using 2.0 g.

Acceptance criteria: NMT 1 ppm

5 SPECIFIC TESTS

pH 〈791〉

Sample solution: 50 mg/mL in carbon dioxide-free water

Acceptance criteria: 4.5–7.0

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight containers.

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