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].
Packaging and storage—
Preserve in well-closed containers.
Identification—
Solution:
500 µg per mL.
Medium:
hydrochloric acid in methanol (1 in 1000).
C:
A saturated solution responds to the tests for
Chloride 
191
.
Ordinary impurities 466—
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 UV light.
Limits—
The sum of the intensities of all secondary spots obtained from the Test solution corresponds to not more than 1.0%.
Assay—
Dissolve about 300 mg of Diphenoxylate Hydrochloride, accurately weighed, in 75 mL of glacial acetic acid, add 4 mL of
mercuric acetate TS, and titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Each mL of 0.1 N perchloric acid is equivalent to 48.91 mg of C
30H
32N
2O
2·HCl.
;)
for 2 hours: it loses not more than 0.5% of its weight.