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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.
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
(MDPP05) Monograph Development-Psychiatrics and Psychoactives
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3307
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.