Pimozide
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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 98.0percent and not more than 102.0percent of C28H29F2N3O,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
Identification—
A:
Infrared Absorption á197Kñ.
Solution:
35µg per mL.
Medium:
0.1Nhydrochloric acid in methanol (1in 10).
Loss on drying á731ñ—
Dry it in vacuum at 80
for 4hours:it loses not more than 0.5%of its weight.
for 4hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.2%,a 2-g portion and a platinum crucible being used for the test.
Heavy metals,Method IIá231ñ:
0.002%.
Ordinary impurities á466ñ—
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%.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Dissolve about 320mg of Pimozide,accurately weighed,in 40mLof glacial acetic acid.Titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 46.16mg of C28H29F2N3O.
Auxiliary Information—
Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 1562
Phone Number:1-301-816-8165