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Prochlorperazine
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C20H24ClN3S 373.94

10H-Phenothiazine, 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl]-.
2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine [58-38-8].
» Prochlorperazine contains not less than 98.0 percent and not more than 101.0 percent of C20H24ClN3S.
Packaging and storage— Preserve in tight, light-resistant containers.
USP Reference standards 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— It meets the requirements under Identification—Organic Nitrogenous Bases 181, USP Prochlorperazine Maleate RS being used as the standard for comparison.
Residue on ignition 281: not more than 0.1%.
Ordinary impurities 466—
Test solution: methanol.
Standard solution: methanol.
Eluant: a mixture of methanol and ammonium hydroxide (100:1).
Visualization: 1.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Assay— Transfer about 400 mg of Prochlorperazine, accurately weighed, to a 125-mL conical flask, add 30 mL of glacial acetic acid, and warm on a steam bath to dissolve. Add 2 drops of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 18.70 mg of C20H24ClN3S.
Auxiliary Information— Staff Liaison : Elena Gonikberg, Ph.D., Scientist
Expert Committee : (MDGRE05) Monograph Development-Gastrointestinal Renal and Endocrine
USP29–NF24 Page 1813
Phone Number : 1-301-816-8251