Diphenoxylate Hydrochloride
;)
4-Piperidinecarboxylic acid,1-(3-cyano-3,3-diphenylpropyl)-4-phenyl-,ethyl ester,monohydrochloride.
Ethyl 1-(3-cyano-3,3-diphenylpropyl)-4-phenylisonipecotate monohydrochloride [3810-80-8].
»Diphenoxylate Hydrochloride contains not less than 98.0percent and not more than 102.0percent of C30H32N2O2·HCl,calculated on the dried basis.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:
Infrared Absorption á197Kñ.
Solution:
500µg per mL.
Medium:
hydrochloric acid in methanol (1in 1000).
C:
Asaturated solution responds to the tests for Chloride á191ñ.
Loss on drying á731ñ—
Dry it at 105
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Ordinary impurities á466ñ—
Test solution:
chloroform.
Standard solution:
chloroform.
Eluant:
a mixture of chloroform,cyclohexane,dehydrated alcohol,and formic acid (50:40:10:1).
Visualization:
17;then examine the plate immediately under short-wavelength UVlight.
Limits—
The sum of the intensities of all secondary spots obtained from the Test solutioncorresponds to not more than 1.0%.
Assay—
Dissolve about 300mg of Diphenoxylate Hydrochloride,accurately weighed,in 75mLof glacial acetic acid,add 4mLof mercuric acetate TS,and titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Each mLof 0.1Nperchloric acid is equivalent to 48.91mg of C30H32N2O2·HCl.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 670
Phone Number:1-301-816-8251