Droperidol

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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2H-Benzimidazol-2-one, 1-[1-[4-(4-uorophenyl)-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 CAS RN^®: 548-73-2; UNII: O9U0F09D5X.

>> Droperidol, dried in vacuum at 70° for 4 hours, contains not less than 98.0 percent and not more than 102.0 percent of C₂₂H₂₂FN₃O₂.

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

USP REFERENCE STANDARDS (11)-

USP Droperidol RS

Identification-

Change to read:

A: SPECTROSCOPIC IDENTIFICATION TESTS (197). Infrared Spectroscopy: 197K

Change to read:

B: SPECTROSCOPIC IDENTIFICATION TESTS (197), Ultraviolet-Visible Spectroscopy: 197U

Solution: 15 µg per mL..

Medium: 0.1 N hydrochloric acid in isopropyl alcohol (1 in 10).

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%.

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%). 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.