Droperidol
379.432H-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].» 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.
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.
Identification—
B:
Ultraviolet Absorption 
197U
—
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.
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%.
281:
not more than 0.2%.
Heavy metals, Method II 231:
0.002%.
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%).
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.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
| Monograph | Ravi Ravichandran, Ph.D.
Senior Scientist 1-301-816-8330 |
(MDPP05) Monograph Development-Psychiatrics and Psychoactives |
| Reference Standards | Lili Wang, Technical Services Scientist 1-301-816-8129 RSTech@usp.org |
USP32–NF27 Page 2219
Pharmacopeial Forum: Volume No. 29(6) Page 1875