Iodoquinol Tablets
»Iodoquinol Tablets contain not less than 95.0percent and not more than 105.0percent 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 5mg of iodoquinol,with 10mLof carbon disulfide,and filter:the filtrate responds to Identificationtest Aunder Iodoquinol.
B: Place a portion of the powdered Tablets prepared for the Assay,equivalent to about 50mg of iodoquinol,in a dry test tube,add 1mLof sulfuric acid,and warm gently:violet vapors of iodine are evolved.
Uniformity of dosage units á905ñ: meet the requirements.
Soluble iodides— Digest a quantity of powdered Tablets,equivalent to 100mg of iodoquinol,with 5mLof water for 10minutes,cool,and filter.To the filtrate add 1mLof 3Nhydrochloric acid,2drops of ferric chloride TS,and 2mLof chloroform,shake gently,and allow to separate:any violet color in the chloroform is not more intense than that in a blank to which 0.2mg of potassium iodide has been added.
Assay— Weigh and finely powder not less than 20Tablets.Using a portion of the powder,accurately weighed and equivalent to about 14mg of iodoquinol,proceed as directed in the Assayunder Iodoquinol.Each mLof 0.02Nsodium thiosulfate is equivalent to 0.6616mg of C9H5I2NO.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1043
Phone Number:1-301-816-8394
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