Trimethobenzamide Hydrochloride
(trye meth'' oh ben' za mide hye'' droe klor' ide).
+'&img=../../images/v35300/g-852.gif&casNumber=554-92-7&usp=35&nf=30&chemicalStructureImage=true&ID='+parent.myID,600,500);)
424.92Benzamide, N-[[4-[2-(dimethylamino)ethoxy]phenyl]methyl]-3,4,5-trimethoxy-, monohydrochloride.
N-[p-[2-(Dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride
[554-92-7].» Trimethobenzamide Hydrochloride, dried at 105
for 4 hours, contains not less than 98.5 percent and not more than 100.5 percent of C21H28N2O5·HCl.
for 4 hours, contains not less than 98.5 percent and not more than 100.5 percent of C21H28N2O5·HCl.
Packaging and storage—
Preserve in well-closed containers.
USP Reference standards 
11
—
11—
USP Trimethobenzamide Hydrochloride RS 
') + '&img=../../images/v35300/cas-554-92-7.gif',600,500);)
Identification—
B:
Ultraviolet Absorption 197U—
197U—
Solution:
20 µg per mL.
Medium:
0.1 N hydrochloric acid.
Absorptivities at 258 nm, calculated on the dried basis, do not differ by more than 3.0%.
C:
It meets the requirements of the Thin-layer Chromatographic Identification Test 201. Prepare the test solution by dissolving 10 mg of Trimethobenzamide Hydrochloride in 10.0 mL of methanol. Apply 10-µL portions of the test solution and the Standard solution to the plate, and develop in a solvent system consisting of a mixture of ethyl acetate, alcohol, and ammonium hydroxide (90:10:5).
201. Prepare the test solution by dissolving 10 mg of Trimethobenzamide Hydrochloride in 10.0 mL of methanol. Apply 10-µL portions of the test solution and the Standard solution to the plate, and develop in a solvent system consisting of a mixture of ethyl acetate, alcohol, and ammonium hydroxide (90:10:5).
D:
It meets the requirements of the tests for Chloride 191.
191.
Melting range, Class I 741:
between 186 and 190.
741:
between 186 and 190.
Loss on drying 731—
Dry it at 105 for 4 hours: it loses not more than 0.5% of its weight.
731—
Dry it at 105 for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281:
not more than 0.1%.
281:
not more than 0.1%.
Heavy metals, Method I 231—
Dissolve 1.0 g in 20 mL of water, add 2 mL of 1 N acetic acid, and dilute with water to 25 mL: the limit is 0.002%.
231—
Dissolve 1.0 g in 20 mL of water, add 2 mL of 1 N acetic acid, and dilute with water to 25 mL: the limit is 0.002%.
Assay—
Dissolve about 1.3 g of Trimethobenzamide Hydrochloride, previously dried and accurately weighed, in 80 mL of glacial acetic acid and 15 mL of mercuric acetate TS. Titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically using suitable electrodes. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 42.49 mg of C21H28N2O5·HCl.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Elena Gonikberg, Ph.D.
Principal Scientific Liaison 1-301-816-8251 |
(SM32010) Monographs - Small Molecules 3 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4952
Pharmacopeial Forum: Volume No. 29(5) Page 1589