C11H12N2S·HCl 240.75

Imidazo[2,1-b]thiazole, 2,3,5,6-tetrahydro-6-phenyl-, monohydrochloride, (S)-.
()-2,3,5,6-Tetrahydro-6-phenylimidazo[2,1-b]thiazole monohydrochloride [16595-80-5].

Packaging and storage— Preserve in well-closed containers, protected from light.

USP Reference standards 11— USP Levamisole Hydrochloride RS.

Completeness of solution 641— A test solution of 500 mg of Levamisole Hydrochloride dissolved in 10 mL of water meets the requirements.

Color of solution— The test solution prepared for the test for Completeness of solution is colorless or not more intensely colored than a color matching fluid prepared by mixing 2.5 mL of Matching Fluid F (see Color and Achromicity 631) with 97.5 mL of 0.12 N hydrochloric acid.

Identification—

Melting range 741: between 226 and 231.

Light absorption— Its absorbance (see Spectrophotometry and Light-scattering 851) at 310 nm, determined in a 0.2 N methanolic hydrochloric acid solution containing 1 mg per mL using a 1-cm cell, is not more than 0.20.

Specific rotation 781S: between 121.5 and 128.0.

pH 791: between 3.0 and 4.5, in a solution (1 in 20).

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: 0.001%.

Chromatographic purity— Prepare a solution of it in methanol containing 50 mg per mL (Test solution A). Dilute 1.0 mL of Test solution A to 10 mL with methanol, and mix (Test solution B). Prepare a solution of USP Levamisole Hydrochloride RS in methanol having a concentration of 5 mg per mL (Reference solution A). Dilute 1.0 mL of Test solution B to 20 mL with methanol, and mix (Reference solution B). Apply separate 10-µL portions of the four solutions on the starting line 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 toluene, acetone, and ammonium hydroxide (60:40:1) until the solvent front has moved about three-fourths of the length of the plate. Remove the plate from the developing chamber, and dry it at 105 for 15 minutes. Locate the spots on the plate by examination under short-wavelength UV light: any spot obtained from Test solution A, other than the one corresponding to levamisole, does not exceed, in size or intensity, the principal spot obtained from Reference solution B, corresponding to not more than 0.5% of any individual impurity. Expose the plate to iodine vapor in a closed chamber for 15 minutes, and locate the spots on the plate: any spot obtained from Test solution A, other than the one corresponding to levamisole, does not exceed, in size or intensity, the principal spot obtained from Reference solution B, corresponding to not more than 0.5% of any individual impurity, and the total of all impurities found does not exceed 1.0%.

Residual solvents 467: meets the requirements.

Assay— Dissolve about 200 mg of Levamisole Hydrochloride, accurately weighed, in 30 mL of alcohol. Add 5.0 mL of 0.01 N hydrochloric acid, and titrate with 0.1 N sodium hydroxide VS, determining the two inflection points potentiometrically. Determine the volume, in mL, of 0.1 N sodium hydroxide consumed between the two inflection points. Each mL of 0.1 N sodium hydroxide consumed is equivalent to 24.08 mg of C11H12N2S·HCl.

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

USP29–NF24 Page 1236

Phone Number : 1-301-816-8394