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Trimethobenzamide Hydrochloride Injection
» Trimethobenzamide Hydrochloride Injection is a sterile solution of Trimethobenzamide Hydrochloride in Water for Injection. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C21H28N2O5·HCl.
Packaging and storage— Preserve in single-dose or in multiple-dose containers, preferably of Type I glass.
A: It meets the requirements of Identification test A under Trimethobenzamide Hydrochloride Capsules.
B: Transfer a volume of Injection, equivalent to about 100 mg of trimethobenzamide hydrochloride, to a separator containing 20 mL of water. Add 2 mL of 1 N sodium hydroxide, and proceed as directed in Identification test B under Trimethobenzamide Hydrochloride Capsules, beginning with “Extract with 15 mL of chloroform.”
C: Dilute a portion of Injection quantitatively and stepwise with methanol to obtain a solution containing 2.5 mg of trimethobenzamide hydrochloride per mL: this solution meets the requirements of the Thin-layer Chromatographic Identification Test 201, a solvent system consisting of a mixture of ethyl acetate, alcohol, and ammonium hydroxide (90:10:5) being used.
Bacterial endotoxins 85 It contains not more than 1.80 USP Endotoxin Units per mg of trimethobenzamide hydrochloride.
pH 791: between 4.5 and 5.5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay— Transfer to a suitable separator an accurately measured volume of Injection, equivalent to about 200 mg of trimethobenzamide hydrochloride. Add 5 mL of water and 3 mL of dilute hydrochloric acid (1 in 12), and extract with four 20-mL portions of ether, collecting the ether extracts in a second separator, and transferring the aqueous layer to a 500-mL volumetric flask. Wash the combined ether extracts with one 20-mL portion of water, transfer the aqueous layer to the 500-mL volumetric flask, dilute with water to volume, and mix. Dilute 5.0 mL of the solution with dilute hydrochloric acid (1 in 120) to 100.0 mL, and mix. Concomitantly determine the absorbances of this solution and a Standard solution of USP Trimethobenzamide Hydrochloride RS in the same medium having a known concentration of about 20 µg per mL, in 1-cm cells at the wavelength of maximum absorbance at about 258 nm, with a suitable spectrophotometer, using dilute hydrochloric acid (1 in 120) as the blank. Calculate the quantity, in mg, of C21H28N2O5·HCl in each mL of the Injection taken by the formula:
(10C / V)(AU / AS),
in which C is the concentration, in µg per mL, of USP Trimethobenzamide RS in the Standard solution, V is the volume, in mL, of Injection taken, and AU and AS are the absorbances of the solution from the Injection and the Standard solution, respectively.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 2211
Phone Number : 1-301-816-8251