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Potassium Iodide Delayed-Release Tablets
» Potassium Iodide Delayed-Release Tablets contain not less than 94.0 percent and not more than 106.0 percent of the labeled amount of KI for Tablets of 300 mg or more, and not less than 92.5 percent and not more than 107.5 percent for Tablets of less than 300 mg.
Packaging and storage— Preserve in tight containers.
Disintegration 701— Proceed as directed for Delayed-Release (enteric coated) Tablets: the Tablets do not disintegrate after 1 hour of agitation in simulated gastric fluid TS, but they disintegrate within 90 minutes in simulated intestinal fluid TS.
Residual solvents 467: meet the requirements.
(Official January 1, 2007)
Other requirements— Tablets respond to the Identification test and meet the requirements for Uniformity of dosage units and Assay under Potassium Iodide Tablets.
Auxiliary Information— Staff Liaison : Behnam Davani, Ph.D., MBA, Senior Scientist
Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials
USP29–NF24 Page 1773
Phone Number : 1-301-816-8394