» 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.
B: Ultraviolet Absorption 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%.
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%).
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.
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USP32NF27 Page 2219Pharmacopeial Forum: Volume No. 29(6) Page 1875