Potassium Iodide Delayed-Release Tablets
»Potassium Iodide Delayed-Release Tablets contain not less than 94.0percent and not more than 106.0percent of the labeled amount of KIfor Tablets of 300mg or more,and not less than 92.5percent and not more than 107.5percent for Tablets of less than 300mg.
Packaging and storage— Preserve in tight containers.
Disintegration á701ñ Proceed as directed for Delayed-Release (enteric coated)Tablets:the Tablets do not disintegrate after 1hour of agitation in simulated gastric fluid TS,but they disintegrate within 90minutes in simulated intestinal fluid TS.
Other requirements— Tablets respond to the Identificationtest and meet the requirements for Uniformity of dosage unitsand Assayunder Potassium Iodide Tablets.
Auxiliary Information— Staff Liaison:Behnam Davani,Ph.D.,MBA,Senior Scientist
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1596
Phone Number:1-301-816-8394