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).
Loss on drying 731
Dry it in vacuum at 80
for 4 hours: it loses not more than 0.5% of its weight.
Heavy metals, Method II 231:
0.002%.
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%.
Organic volatile impurities, Method V 467:
meets the requirements.
Solvent
Use dimethyl sulfoxide.
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.