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 á11ñ— USP Droperidol RS.

Identification—

Loss on drying á731ñ— Dry it in vacuum at 70for 4hours:it loses not more than 5.0%of its weight.

Residue on ignition á281ñ: not more than 0.2%.

Heavy metals,Method IIá231ñ: 0.002%.

Limit of 4,4¢-bis[1,2,3,6-tetrahydro-4-(2-oxo-1-benzimidazolinyl)-1-pyridyl]butyrophenone— Dissolve about 30.0mg of the sample in 70mLof isopropyl alcohol in a 100-mLvolumetric flask.Add 10.0mLof 0.1Nhydrochloric 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 330nm,with a suitable spectrophotometer,using a 1in 10solution of 0.1Nhydrochloric acid in isopropyl alcohol as the blank,is not more than 0.7(equivalent to limit of 1.5%).

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

Expert Committee:(PA3)Pharmaceutical Analysis 3

USP28–NF23Page 704

Phone Number:1-301-816-8330