Trimethobenzamide Hydrochloride Click to View Image C21H28N2O5·HCl 424.92
N-[p-[2-(Dimethylamino)ethoxy]benzyl]-3,4,5-trimethoxybenzamide monohydrochloride [554-92-7]. »Trimethobenzamide Hydrochloride,dried at 105for 4hours,contains not less than 98.5percent and not more than 100.5percent of C21H28N2O5·HCl. Packaging and storage— Preserve in well-closed containers. USP Reference standards á11ñ USP Trimethobenzamide Hydrochloride RS. 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. Melting range,Class Iá741ñ: between 186and 190. Loss on drying á731ñ Dry it at 105for 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