Medium: water;900mL.

Apparatus 1: 100rpm.

Time: 2hours.

Potassium stock solutionand Standard preparations— Prepare as directed in the Assayunder Potassium Chloride Oral Solution.

Procedure— Filter the solution under test,and dilute quantitatively with Dissolution Mediumto obtain a test solution containing about 60µg of potassium chloride per mL.Add 5.0mLof the test solution to a 100-mLvolumetric flask,add 2.0mLof sodium chloride solution (1in 5)and 1.0mLof hydrochloric acid,dilute with water to volume,mix,and proceed as directed for Procedurein the Assayunder Potassium Chloride Oral Solution.Calculate the quantity,in mg,of KCl dissolved by the formula: in which Fis the extent of dilution of the solution under test,and the other terms are as defined therein.

Tolerances— Not more than 35%(Q)of the labeled amount of KCl is dissolved in 2hours.The requirements are met if the quantities dissolved from the Capsules tested conform to the accompanying acceptance table instead of the table shown under Dissolution á711ñ.

Potassium stock solutionand Standard preparations— Prepare as directed in the Assayunder Potassium Chloride Oral Solution.

Assay preparation— Place not less than 20Capsules in a suitable container with 400mLof water,heat to boiling,and boil for 20minutes.Allow to cool,transfer the solution to a 1000-mLvolumetric flask,dilute with water to volume,and mix.Filter,discarding the first 20mLof the filtrate.Transfer an accurately measured volume of the subsequent filtrate,equivalent to about 60mg of potassium chloride,to a 1000-mLvolumetric flask,dilute with water to volume,and mix.(Retain a portion of the filtrate for use in the Identificationtest.)Transfer 5.0mLof the resulting solution to a 100-mLvolumetric flask,add 2.0mLof sodium chloride solution (1in 5)and 1.0mLof hydrochloric acid,dilute with water to volume,and mix.

Procedure— Proceed as directed for Procedurein the Assayunder Potassium Chloride Oral Solution.Calculate the quantity,in mg,of KCl in each Capsule taken by the formula: in which Tis the labeled quantity,in mg,of potassium chloride in each Capsule,Dis the concentration,in µg per mL,of potassium chloride in the Assay preparation,based on the labeled quantity per Capsule and the extent of dilution,and the other terms are as defined therein.

Stage	Number Tested	Acceptance Criteria
S1	6	Each unit is within the range Q±30%.
S2	6	Average of 12units (S1+S2)is within the range between Q-30%and Q+35%,and no unit is outside the range Q±40%.
S3	12	Average of 24units (S1+S2+S3)is within the range between Q-30%and Q+35%,and not more than 2units are outside the range Q±40%.