» Potassium Chloride contains not less than 99.0 percent and not more than 100.5 percent of KCl, calculated on the dried basis.
Packaging and storagePreserve in well-closed containers.
LabelingWhere Potassium Chloride is intended for use in hemodialysis, it is so labeled.
IdentificationA solution (1 in 20) responds to the tests for Potassium 191 and for Chloride 191.
Acidity or alkalinityTo a solution of 5.0 g in 50 mL of carbon dioxidefree water add 3 drops of phenolphthalein TS: no pink color is produced. Then add 0.30 mL of 0.020 N sodium hydroxide: a pink color is produced.
Loss on drying 731Dry it at 105
for 2 hours: it loses not more than 1.0% of its weight.
Iodide or bromide
IODIDE
Standard stock solutionTransfer an accurately weighed quantity, about 41 mg, of potassium iodide to a 25-mL volumetric flask. Dissolve in and dilute with water to volume, and mix.
Standard solutionDilute 1.0 mL of Standard stock solution with water to 25 mL, and mix. Dilute 2.0 mL of this solution with water to 8 mL, and proceed as directed for Test solution beginning with Add 1 mL each of chloroform.
Test solutionDissolve 2 g of Potassium Chloride in 8 mL of water. Add 1 mL each of chloroform and diluted hydrochloric acid, then add 2 drops of a chloramine T solution (0.1 in 100), and shake gently. The violet color of the chloroform layer is not darker than that of a concomitantly prepared Standard solution: the limit is 0.005%.
BROMIDE
Standard solutionTransfer an accurately weighed quantity, about 32 mg, of sodium bromide to a 25-mL volumetric flask. Dissolve in and dilute with water to volume, and mix. Dilute 2.0 mL of this solution with water to 8 mL, and proceed as directed for Test solution beginning with Add 1 mL each of chloroform.
Test solutionDissolve 2 g of Potassium Chloride in 8 mL of water. Add 1 mL each of chloroform and diluted hydrochloric acid, then add 5 drops of a chloramine T solution (1 in 100), and shake gently. The brown color of the chloroform layer is not darker than that of a concomitantly prepared Standard solution: the limit is 0.1%.
Aluminum 206 (where it is labeled as intended for use in hemodialysis)Proceed as directed using 2.0 g of Potassium Chloride to prepare the Test Preparation: the limit is 1 µg per g.
Calcium and magnesiumTo 20 mL of a solution (1 in 100) add 2 mL each of 6 N ammonium hydroxide, ammonium oxalate TS, and dibasic sodium phosphate TS: no turbidity is produced within 5 minutes.
SodiumA solution (1 in 20), tested on a platinum wire, does not impart a pronounced yellow color to a nonluminous flame.
Heavy metals 231Dissolve 2.0 g in 25 mL of water: the limit is 0.001%.
Organic volatile impurities, Method I 467: meets the requirements.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
AssayDissolve about 200 mg of Potassium Chloride, accurately weighed, in 10 mL of water. Add 10 mL of glacial acetic acid, 75 mL of methanol, and 3 drops of eosin Y TS. Titrate, with shaking, with 0.1 N silver nitrate VS to a pink endpoint. Each mL of 0.1 N silver nitrate is equivalent to 7.455 mg of KCl.
Auxiliary InformationStaff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29NF24 Page 1760
Pharmacopeial Forum : Volume No. 29(5) Page 1562
Phone Number : 1-301-816-8143
