Packaging and storage
Preserve in tight containers.
Labeling
Where Magnesium Chloride is intended for use in hemodialysis, it is so labeled.
Identification
A solution (1 in 20) responds to the tests for
Magnesium 191 and for
Chloride 191.
[NOTEWhen performing the test for
Chloride, acidify the sample solution with dilute nitric acid prior to adding 6 N ammonium hydroxide.
]
pH 791:
between 4.5 and 7.0, in a 1 in 20 solution in carbon dioxide-free water.
Change to read:
Insoluble matter
Dissolve 20 g, accurately weighed, in 200 mL of water, heat to boiling, and digest in a covered beaker on a steam bath for 1 hour. Filter through a tared filtering crucible, wash thoroughly,
USP29 dry at 115
,
and determine
USP29 the weight of the residue:
not more than 0.005% is found.
USP29
Sulfate 221
A 10-g portion shows no more sulfate than corresponds to 0.50 mL of 0.020 N sulfuric acid (0.005%).
Barium
Dissolve 1 g in 10 mL of water, and add 1 mL of 2 N sulfuric acid: no turbidity is produced within 2 hours.
Limit of calcium
Dilute hydrochloric acid, Lanthanum solution, Standard preparations, and Blank solution
Proceed as directed in the test for
Limit of calcium under
Magnesium Carbonate.
Test preparation
Transfer 10.0 g of Magnesium Chloride to a 200-mL volumetric flask, add water to dissolve it, add 4 mL of Lanthanum solution, dilute with water to volume, and mix.
Procedure
Proceed as directed for
Procedure in the test for
Limit of calcium under
Magnesium Carbonate. Calculate the percentage of calcium in the Magnesium Chloride taken by multiplying the concentration, in µg per mL, of calcium found in the
Test preparation by 0.002: the limit is 0.01%.
Potassium
Dissolve 5 g in 5 mL of water, and add 0.2 mL of
sodium bitartrate TS: no turbidity is produced within 5 minutes.
Aluminum 206 (where it is labeled as intended for use in hemodialysis)
Proceed as directed using 2.0 g of Magnesium Chloride to prepare the
Test Preparation: the limit is 1 µg per g.
Organic volatile impurities, Method I 467:
meets the requirements.
Assay
Accurately weigh about 450 mg of Magnesium Chloride, dissolve in 25 mL of water, add 5 mL of ammoniaammonium 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 MgCl
2·6H
2O.
Auxiliary Information
Staff Liaison :
Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29NF24 Page 1294
Pharmacopeial Forum : Volume No. 31(2) Page 420
Phone Number : 1-301-816-8251