U.S. PHARMACOPEIA

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Iodoquinol Tablets
» Iodoquinol Tablets contain not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C9H5I2NO.
Packaging and storage— Preserve in well-closed containers.
Identification—
A: Shake a portion of finely powdered Tablets, equivalent to about 5 mg of iodoquinol, with 10 mL of carbon disulfide, and filter: the filtrate responds to Identification test A under Iodoquinol.
B: Place a portion of the powdered Tablets prepared for the Assay, equivalent to about 50 mg of iodoquinol, in a dry test tube, add 1 mL of sulfuric acid, and warm gently: violet vapors of iodine are evolved.
Uniformity of dosage units 905: meet the requirements.
Soluble iodides— Digest a quantity of powdered Tablets, equivalent to 100 mg of iodoquinol, with 5 mL of water for 10 minutes, cool, and filter. To the filtrate add 1 mL of 3 N hydrochloric acid, 2 drops of ferric chloride TS, and 2 mL of chloroform, shake gently, and allow to separate: any violet color in the chloroform is not more intense than that in a blank to which 0.2 mg of potassium iodide has been added.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Assay— Weigh and finely powder not less than 20 Tablets. Using a portion of the powder, accurately weighed and equivalent to about 14 mg of iodoquinol, proceed as directed in the Assay under Iodoquinol. Each mL of 0.02 N sodium thiosulfate is equivalent to 0.6616 mg of C9H5I2NO.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 1157
Phone Number : 1-301-816-8394