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Trimethobenzamide Hydrochloride
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C21H28N2O5·HCl 424.92

Benzamide, 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.
Packaging and storage— Preserve in well-closed containers.
Identification—
B: Ultraviolet Absorption 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).
D: It meets the requirements of the tests for Chloride 191.
Melting range, Class I 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.
Residue on ignition 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%.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
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— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 2210
Pharmacopeial Forum : Volume No. 29(5) Page 1589
Phone Number : 1-301-816-8251