Potassium Iodide Oral Solution, chemical structure, molecular formula, Reference Standards

Potassium Iodide Oral Solution

»Potassium Iodide Oral Solution contains,not less than 94.0percent and not more than 106.0percent of the labeled amount of KI.

NOTE—If Potassium Iodide Oral Solution is not to be used within a short time,add 0.5mg of sodium thiosulfate for each g of KI.Crystals of potassium iodide may form in Potassium Iodide Oral Solution under normal conditions of storage,especially if refrigerated.

Packaging and storage— Preserve in tight,light-resistant containers.

Identification— It responds to the tests for Potassium á191ñand for Iodide á191ñ.

Uniformity of dosage units á905ñ—

FOR ORAL SOLUTION PACKAGED IN SINGLE-UNIT CONTAINERS: meets the requirements.

Deliverable volume á698ñ—

FOR ORAL SOLUTION PACKAGED IN MULTIPLE-UNIT CONTAINERS: meets the requirements.

Assay— Dilute an accurately measured volume of Oral Solution with water to obtain a solution containing about 50mg of potassium iodide per mL.To 10.0mLof this solution,in a 150-mLbeaker,add about 40mLof water,25mLof alcohol,and 1.0mLof 1Nnitric acid.Titrate with 0.1Nsilver nitrate VS,determining the endpoint potentiometrically,using silver-calomel electrodes and a salt bridge containing 4percent agar in a saturated potassium nitrate solution.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nsilver nitrate is equivalent to 16.60mg of KI.

Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist

Expert Committee:(PA7)Pharmaceutical Analysis 7

USP28–NF23Page 1595

Pharmacopeial Forum:Volume No.29(6)Page 1967

Phone Number:1-301-816-8394