C16H13N3O3 295.29

Carbamic acid, (5-benzoyl-1H-benzimidazol-2-yl), methyl ester.
Methyl 5-benzoyl-2-benzimidazolecarbamate [31431-39-7].

Packaging and storage— Preserve in well-closed containers.

USP Reference standards 11— USP Mebendazole RS.

Identification, Infrared Absorption 197K.

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 II 231: 0.002%.

Chromatographic purity— Dissolve 50 mg in 1.0 mL of 96 percent formic acid in a 10-mL volumetric flask, add chloroform to volume, and mix. Similarly prepare a solution of USP Mebendazole RS in the same medium having a concentration of 5 mg per mL. Transfer 1.0 mL of this Standard solution to a 200-mL volumetric flask, add a mixture of chloroform and 96 percent formic acid (9:1) to volume, and mix (diluted Standard solution). Apply 10-µL portions of the test solution, the Standard solution, and the diluted Standard solution to a suitable thin-layer chromatographic plate (see Chromatography 621) coated with a 0.25-mm layer of chromatographic silica gel mixture. Allow the spots to dry, and develop the chromatogram in a solvent system consisting of a mixture of chloroform, methanol, and 96 percent formic acid (90:5:5) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, mark the solvent front, allow the solvent to evaporate, and examine the plate under short-wavelength UV light: the RF value of the principal spot obtained from the test solution corresponds to that obtained from the Standard solution, and no spot, other than the principal spot, in the chromatogram of the test solution is larger or more intense than the principal spot obtained from the diluted Standard solution.

Residual solvents 467: meets the requirements.

Assay— Dissolve about 225 mg of Mebendazole, accurately weighed, in 30 mL of glacial acetic acid. Titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically, using a calomel-glass electrode system. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 29.53 mg of C16H13N3O3.

Expert Committee : (MDAA05) Monograph Development-Antivirals and Antimicrobials

USP29–NF24 Page 1316

Phone Number : 1-301-816-8394