Prochlorperazine Maleate
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.
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.
Auxiliary Information— Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
Monograph Elena Gonikberg, Ph.D.
Senior Scientist
(MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
Reference Standards Lili Wang, Technical Services Scientist
USP32–NF27 Page 3397
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.