Iodine Tincture
»Iodine Tincture contains,in each 100mL,not less than 1.8g and not more than 2.2g of iodine (I),and not less than 2.1g and not more than 2.6g of sodium iodide (NaI).
Iodine Tincture may be prepared by dissolving 20g of Iodine and 24g of Sodium Iodide in 500mLof Alcohol and then adding Purified Water to make the product measure 1000mL.
Packaging and storage— Preserve in tight containers.
Identification—
A: Add 1drop to a mixture of 1mLof starch TSand 9mLof water:a deep blue color is produced.
B: Evaporate a few mLon a steam bath to dryness:the residue responds to the flame test for Sodium á191ñ,and to the tests for Iodide á191ñ.
Alcohol content á611ñ: between 44.0%and 50.0%of C2H5OH.
Assay for iodine— Proceed as directed in the Assay for iodineunder Iodine Topical Solution,using 10mLof Iodine Tincture.
Assay for sodium iodide— Proceed as directed in the Assay for sodium iodideunder Iodine Topical Solution,using 10mLof Iodine Tincture.The difference between the number of mLof 0.05Mpotassium iodate used and half the number of mLof 0.1Nsodium thiosulfate used in the Assay for iodine,multiplied by 14.99,represents the number of mg of NaIin the volume of Iodine Tincture taken.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1030
Phone Number:1-301-816-8394