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Haloperidol
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C21H23ClFNO2 375.86

1-Butanone, 4-[4-(4-chlorophenyl)-4-hydroxy-1-piperidinyl]-1-(4-fluorophenyl)-.
4-[4-(p-Chlorophenyl)-4-hydroxypiperidino]-4¢-fluorobutyrophenone [52-86-8].
» Haloperidol contains not less than 98.0 percent and not more than 102.0 percent of C21H23ClFNO2, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
B: Ultraviolet Absorption 197U—
Solution: 20 µg per mL.
Medium: dilute hydrochloric acid (1 in 100) in isopropyl alcohol (1 in 9).
Absorptivities at 245 nm, calculated on the dried basis, do not differ by more than 3.0%.
Melting range 741: between 149 and 155, determined after drying in vacuum at 60 for 3 hours.
Loss on drying 731— Dry it in vacuum at 60 for 3 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Limit of haloperidol related compound A—
Test solution— Dissolve about 80 mg of Haloperidol, accurately weighed, in 80 mL of isopropyl alcohol in a 100-mL volumetric flask. Add 10 mL of dilute hydrochloric acid (1 in 100), dilute with isopropyl alcohol to volume, and mix.
Standard solution— Prepare a solution containing 800 µg per mL of USP Haloperidol RS and 8 µg per mL of USP Haloperidol Related Compound A RS in isopropyl alcohol containing 10 mL of dilute hydrochloric acid (1 in 100) in each 100 mL of solution.
Procedure— Concomitantly determine the absorbances of the Test solution and the Standard solution at the wavelength of maximum absorbance at about 335 nm, with a suitable spectrophotometer, using isopropyl alcohol containing 10 mL of dilute hydrochloric acid (1 in 100) in each 100 mL of solution as the blank. The absorbance of the Test solution is not greater than that of the Standard solution, corresponding to not more than 1.0%.
Organic volatile impurities, Method V 467: meets the requirements.
Solvent— Use dimethyl sulfoxide.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Dissolve about 125 mg of Haloperidol, accurately weighed, in 25 mL of glacial acetic acid, add 3 drops of p-naphtholbenzein TS, and titrate with 0.05 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.05 N perchloric acid is equivalent to 18.79 mg of C21H23ClFNO2.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 1042
Pharmacopeial Forum : Volume No. 29(6) Page 1897
Phone Number : 1-301-816-8330