Potassium Chloride
KCl 74.55
Potassium chloride.
Potassium chloride [7447-40-7].
»Potassium Chloride contains not less than 99.0percent and not more than 100.5percent of KCl,calculated on the dried basis.
Packaging and storage— Preserve in well-closed containers.
Labeling— Where Potassium Chloride is intended for use in hemodialysis,it is so labeled.
Identification— Asolution (1in 20)responds to the tests for Potassium á191ñand for Chloride á191ñ.
Acidity or alkalinity— To a solution of 5.0g in 50mLof carbon dioxide–free water add 3drops of phenolphthalein TS:no pink color is produced.Then add 0.30mLof 0.020Nsodium hydroxide:a pink color is produced.
Loss on drying á731ñ— Dry it at 105for 2hours:it loses not more than 1.0%of its weight.
Iodide or bromide—
IODIDE—
Standard stock solution— Transfer an accurately weighed quantity,about 41mg,of potassium iodide to a 25-mLvolumetric flask.Dissolve in and dilute with water to volume,and mix.
Standard solution— Dilute 1.0mLof Standard stock solutionwith water to 25mL,and mix.Dilute 2.0mLof this solution with water to 8mL,and proceed as directed for Test solution beginning with “Add 1mLeach of chloroform”.
Test solution— Dissolve 2g of Potassium Chloride in 8mLof water.Add 1mLeach of chloroform and diluted hydrochloric acid,then add 2drops of a chloramine Tsolution (0.1in 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 solution— Transfer an accurately weighed quantity,about 32mg,of sodium bromide to a 25-mLvolumetric flask.Dissolve in and dilute with water to volume,and mix.Dilute 2.0mLof this solution with water to 8mL,and proceed as directed for Test solutionbeginning with “Add 1mLeach of chloroform”.
Test solution— Dissolve 2g of Potassium Chloride in 8mLof water.Add 1mLeach of chloroform and diluted hydrochloric acid,then add 5drops of a chloramine Tsolution (1in 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 á206ñ(where it is labeled as intended for use in hemodialysis)— Proceed as directed using 2.0g of Potassium Chloride to prepare the Test Preparation:the limit is 1µg per g.
Calcium and magnesium— To 20mLof a solution (1in 100)add 2mLeach of 6Nammonium hydroxide,ammonium oxalate TS,and dibasic sodium phosphate TS:no turbidity is produced within 5minutes.
Sodium— Asolution (1in 20),tested on a platinum wire,does not impart a pronounced yellow color to a nonluminous flame.
Heavy metals á231ñ— Dissolve 2.0g in 25mLof water:the limit is 0.001%.
Assay— Dissolve about 200mg of Potassium Chloride,accurately weighed,in 10mLof water.Add 10mLof glacial acetic acid,75mLof methanol,and 3drops of eosin Y TS.Titrate,with shaking,with 0.1Nsilver nitrate VSto a pink endpoint.Each mLof 0.1Nsilver nitrate is equivalent to 7.455mg of KCl.
Auxiliary Information— Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1584
Pharmacopeial Forum:Volume No.29(5)Page 1562
Phone Number:1-301-816-8379