(hal'' oh per' i dol).
» 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.
USP Reference standards 11
USP Haloperidol Related Compound A RS
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%.
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.
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USP35NF30 Page 3397Pharmacopeial Forum: Volume No. 29(6) Page 1897