Pimozide
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C28H29F2N3O 461.55

2H-Benzimidazol-2-one, 1-[1-[4,4-bis(4-fluorophenyl)butyl]-4-piperidinyl]-1,3-dihydro-.
1-[1-[4,4-Bis(p-fluorophenyl)butyl]-4-piperidyl]-2-benzimidazolinone [2062-78-4].
» Pimozide contains not less than 98.0 percent and not more than 102.0 percent of C28H29F2N3O, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
Identification—
Solution: 35 µg per mL.
Medium: 0.1 N hydrochloric acid in methanol (1 in 10).
Melting range, Class I 741: between 216 and 220.
Loss on drying 731 Dry it in vacuum at 80 for 4 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.2%, a 2-g portion and a platinum crucible being used for the test.
Ordinary impurities 466
Test solution: chloroform.
Standard solution: chloroform.
Eluant: a mixture of cyclohexane and acetone (1:1).
Visualization: 1, then 17.
Limit— The total of any ordinary impurities observed does not exceed 1.0%.
Assay— Dissolve about 320 mg of Pimozide, accurately weighed, in 40 mL of glacial acetic acid. Titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 46.16 mg of C28H29F2N3O.
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 3307
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.