Trimethobenzamide Hydrochloride
;)
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 4hours,contains not less than 98.5percent and not more than 100.5percent of C21H28N2O5·HCl.
for 4hours,contains not less than 98.5percent and not more than 100.5percent of C21H28N2O5·HCl.
Packaging and storage—
Preserve in well-closed containers.
Identification—
A:Infrared Absorption á197Kñ.
B:Ultraviolet Absorption á197Uñ—
Solution:
20µg per mL.
Medium:
0.1Nhydrochloric acid.
Absorptivities at 258nm,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 á201ñ.Prepare the test solution by dissolving 10mg of Trimethobenzamide Hydrochloride in 10.0mLof methanol.Apply 10-µLportions 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 á191ñ.
Loss on drying á731ñ—
Dry it at 105for 4hours:it loses not more than 0.5%of its weight.
for 4hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Heavy metals,Method Iá231ñ—
Dissolve 1.0g in 20mLof water,add 2mLof 1Nacetic acid,and dilute with water to 25mL:the limit is 0.002%.
Assay—
Dissolve about 1.3g of Trimethobenzamide Hydrochloride,previously dried and accurately weighed,in 80mLof glacial acetic acid and 15mLof mercuric acetate TS.Titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically using suitable electrodes.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 42.49mg of C21H28N2O5·HCl.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1985
Pharmacopeial Forum:Volume No.29(5)Page 1589
Phone Number:1-301-816-8251