Diphenoxylate Hydrochloride
489.054-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 98.0 percent and not more than 102.0 percent of C30H32N2O2·HCl, calculated on the dried basis.
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
.
191.
Loss on drying 731—
Dry it at 105
for 2 hours: it loses not more than 0.5% of its weight.
731—
Dry it at 105 for 2 hours: it loses not more than 0.5% of its weight.
Ordinary impurities 466—
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 C30H32N2O2·HCl.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Elena Gonikberg, Ph.D.
Senior Scientist 1-301-816-8251 |
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 2177