Isopropamide Iodide
;)
Benzenepropanaminium,g-(aminocarbonyl)-N-methyl-N,N-bis(1-methylethyl)-g-phenyl-,iodide.
(3-Carbamoyl-3,3-diphenylpropyl)diisopropylmethylammonium iodide [71-81-8].
»Isopropamide Iodide,dried in vacuum at 60
for 2hours,contains not less than 98.0percent and not more than 101.0percent of C23H33IN2O.
for 2hours,contains not less than 98.0percent and not more than 101.0percent of C23H33IN2O.
Packaging and storage—
Preserve in well-closed,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
B:
To 5mLof a solution (1in 1000)add 5mLof sodium carbonate solution (1in 100),0.5mLof bromophenol blue TS,and 10mLof chloroform,and shake for several minutes:the chloroform layer becomes an intense blue in color.
C:
Asolution (1in 1000)responds to the tests for Iodide á191ñ.
Loss on drying á731ñ—
Dry it in vacuum at 60for 2hours:it loses not more than 1.0%of its weight.
for 2hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.5%,after ignition at 550±25for 4hours.
for 4hours.
Heavy metals,Method IIá231ñ:
0.002%.
Ordinary impurities á466ñ—
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 Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Dissolve about 750mg of Isopropamide Iodide,previously dried and accurately weighed,in 60mLof glacial acetic acid,add 15mLof mercuric acetate TSand crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 48.04mg of C23H33IN2O.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1076
Phone Number:1-301-816-8251