C22H22FN3O2 379.43

2H-Benzimidazol-2-one, 1-[1-[4-(4-fluorophenyl)-4-oxobutyl]-1,2,3,6-tetrahydro-4-pyridinyl]-1,3-dihydro-.
1-1-[3-(p-Fluorobenzoyl)propyl]-1,2,[3,6-tetrahydro-4-pyridyl]-2-benzimidazolinone [548-73-2].

Packaging and storage— Preserve in tight, light-resistant containers, under nitrogen, in a cool place.

USP Reference standards 11— USP Droperidol RS.

Identification—

Loss on drying 731— Dry it in vacuum at 70 for 4 hours: it loses not more than 5.0% of its weight.

Residue on ignition 281: not more than 0.2%.

Heavy metals, Method II 231: 0.002%.

Limit of 4,4¢-bis[1,2,3,6-tetrahydro-4-(2-oxo-1-benzimidazolinyl)-1-pyridyl]butyrophenone— Dissolve about 30.0 mg of the sample in 70 mL of isopropyl alcohol in a 100-mL volumetric flask. Add 10.0 mL of 0.1 N hydrochloric acid, dilute with isopropyl alcohol to volume, and mix. The absorptivity of the solution in 1-cm cells at the wavelength of maximum absorbance at about 330 nm, with a suitable spectrophotometer, using a 1 in 10 solution of 0.1 N hydrochloric acid in isopropyl alcohol as the blank, is not more than 0.7 (equivalent to limit of 1.5%).

Residual solvents 467: meets the requirements.

Assay— Dissolve about 240 mg of Droperidol, previously dried and accurately weighed, in 50 mL of glacial acetic acid, add p-naphtholbenzein TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 37.94 mg of C22H22FN3O2.

Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives

USP29–NF24 Page 770

Phone Number : 1-301-816-8330