Pimozide
(pim' oh zide).
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461.552H-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.
USP Reference standards 
11
—
11—
USP Pimozide RS 
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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.
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.
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.
281:
not more than 0.2%, a 2-g portion and a platinum crucible being used for the test.
Heavy metals, Method II 231:
0.002%.
231:
0.002%.
Ordinary impurities 466—
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 | Hariram Ramanathan, M.S.
Associate Scientific Liaison 1-301-816-8313 |
(SM42010) Monographs - Small Molecules 4 |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 4326