Potassium Iodide Delayed-Release Tablets
DEFINITION
Potassium Iodide Delayed-Release Tablets contain NLT 94.0% and NMT 106.0% of the labeled amount of KI for Tablets of 300 mg or more, and NLT 92.5% and NMT 107.5% for Tablets of less than 300 mg.
IDENTIFICATION
• Identification Tests—General, Potassium 
191
and Iodide 191:
A filtered solution of powdered Tablets meets the requirements.
191 and Iodide 191:
A filtered solution of powdered Tablets meets the requirements.
ASSAY
• Procedure
Sample solution:
Transfer an equivalent to 1.2 g of potassium iodide, from finely powdered Tablets (NLT 20), to a 250-mL volumetric flask. Add 100 mL of water, shake for 20 min, and dilute with water to volume. Filter through paper, discarding the first 20 mL of the filtrate. Transfer 100.0 mL of the filtrate, 25 mL of alcohol, and 1.0 mL of 1 N nitric acid to a 200-mL beaker.
Analysis:
Titrate with 0.1 N silver nitrate VS, using silver–calomel electrodes and a salt bridge containing 4% agar in a saturated potassium nitrate solution. Perform a blank determination (see Titrimetry 541). Each mL of 0.1 N silver nitrate is equivalent to 16.60 mg of KI.
541). Each mL of 0.1 N silver nitrate is equivalent to 16.60 mg of KI.
Acceptance criteria:
94.0%–106.0% of the labeled amount of KI for Tablets of 300 mg or more, and 92.5%–107.5% for Tablets of less than 300 mg
PERFORMANCE TESTS
• Disintegration 701:
Proceed as directed for Delayed-Release (Enteric-Coated) Tablets. The Delayed-Release Tablets do not disintegrate after 1 h of agitation in simulated gastric fluid TS, but they disintegrate within 90 min in simulated intestinal fluid TS.
701:
Proceed as directed for Delayed-Release (Enteric-Coated) Tablets. The Delayed-Release Tablets do not disintegrate after 1 h of agitation in simulated gastric fluid TS, but they disintegrate within 90 min in simulated intestinal fluid TS.
• Uniformity of Dosage Units 905:
Meet the requirements
905:
Meet the requirements
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in tight containers.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Leonel M. Santos, Ph.D.
Senior Scientific Liaison 1-301-816-8168 |
(SM12010) Monographs - Small Molecules 1 |
| 701 |
Margareth R.C. Marques, Ph.D.
Senior Scientific Liaison 1-301-816-8106 |
(GCDF2010) General Chapters - Dosage Forms |
USP35–NF30 Page 4374
Pharmacopeial Forum: Volume No. 34(6) Page 1481