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Isopropamide Iodide
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C23H33IN2O 480.43

Benzenepropanaminium, -(aminocarbonyl)-N-methyl-N,N-bis(1-methylethyl)--phenyl-, iodide.
(3-Carbamoyl-3,3-diphenylpropyl)diisopropylmethylammonium iodide [71-81-8].
» Isopropamide Iodide, dried in vacuum at 60 for 2 hours, contains not less than 98.0 percent and not more than 101.0 percent of C23H33IN2O.
Packaging and storage— Preserve in well-closed, light-resistant containers.
Identification—
B: To 5 mL of a solution (1 in 1000) add 5 mL of sodium carbonate solution (1 in 100), 0.5 mL of bromophenol blue TS, and 10 mL of chloroform, and shake for several minutes: the chloroform layer becomes an intense blue in color.
C: A solution (1 in 1000) responds to the tests for Iodide 191.
Loss on drying 731 Dry it in vacuum at 60 for 2 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.5%, after ignition at 550 ± 25 for 4 hours.
Heavy metals, Method II 231: 0.002%.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of methanol, glacial acetic acid, and water (8:1:1).
Visualization: 2.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 750 mg of Isopropamide Iodide, previously dried and accurately weighed, in 60 mL of glacial acetic acid, add 15 mL of mercuric acetate TS and crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 48.04 mg of C23H33IN2O.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 1191
Phone Number : 1-301-816-8251