Prochlorperazine Maleate
(proe'' klor per' a zeen mal' ee ate).
C20H24ClN3S·2C4H4O4 606.09

10H-Phenothiazine, 2-chloro-10-[3-(4-methyl-1-piperazinyl)- propyl]-, (Z)-2-butenedioate (1:2).
2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine maleate (1:2) [84-02-6].
» Prochlorperazine Maleate contains not less than 98.0 percent and not more than 101.5 percent of C20H24ClN3S·2C4H4O4, calculated on the dried basis.
Packaging and storage— Preserve in tight, light-resistant containers.
USP Reference standard 11
USP Prochlorperazine Maleate RS Click to View Structure
[note—Throughout the following procedures, protect test or assay specimens, the Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware. ]
Identification, Infrared Absorption 197K.
Loss on drying 731 Dry it in vacuum at 60 for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Ordinary impurities 466
Test solution: a mixture of methanol and 1 N sodium hydroxide (9:1).
Standard solution: a mixture of methanol and 1 N sodium hydroxide (9:1).
Eluant: a mixture of methanol and ammonium hydroxide (100:1).
Visualization: 1.
Assay— Transfer to a beaker about 400 mg of Prochlorperazine Maleate, accurately weighed, and dissolve in 30 mL of chloroform, warming on a steam bath to effect solution. Add 100 mL of glacial acetic acid, cool to room temperature, and titrate with 0.05 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.05 N perchloric acid is equivalent to 15.15 mg of C20H24ClN3S·2C4H4O4.
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USP35–NF30 Page 4430