Prochlorperazine Edisylate
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C20H24ClN3S·C2H6O6S2 564.14

10H-Phenothiazine, 2-chloro-10-[3-(4-methyl-1-piperazinyl)propyl]-,1,2-ethanedisulfonate (1:1).
2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine 1,2-ethanedisulfonate (1:1) [1257-78-9].
» Prochlorperazine Edisylate contains not less than 98.0 percent and not more than 101.5 percent of C20H24ClN3S·C2H6O6S2, calculated on the dried basis.
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.
A: It meets the requirements under Identification—Organic Nitrogenous Bases 181, USP Prochlorperazine Maleate RS being used as the standard for comparison.
B: Fuse about 100 mg with a few pellets of sodium hydroxide: the cooled melt responds to the test for Sulfite 191.
Loss on drying 731 Dry it in vacuum at 100 for 3 hours: it loses not more than 0.5% of its weight.
Residue on ignition 281: not more than 0.1%.
Selenium 291: 0.003%, a 100-mg test specimen, mixed with 100 mg of magnesium oxide, being used.
Ordinary impurities 466
Test solution: a mixture of methanol and ammonium hydroxide (9:1).
Standard solution: a mixture of methanol and ammonium hydroxide (9:1).
Eluant: a mixture of chloroform, toluene, alcohol, and ammonium hydroxide (50:50:50:0.5).
Spray reagent— Mix 2 mL of chloroplatinic acid solution (1 in 10) and 50 mL of potassium iodide solution (4 in 100). Dilute with water to 100 mL, and acidify with 1 N hydrochloric acid.
Visualization: 1, followed by Spray reagent.
Assay— Transfer about 750 mg of Prochlorperazine Edisylate, accurately weighed, to a separator containing 40 mL of water, and shake to effect solution. Render the solution alkaline with ammonium hydroxide, and extract with three 25-mL portions of ether. Wash the combined ether extracts once with about 25 mL of water, discard the washing, and evaporate the ether solution on a steam bath to dryness. Dissolve the residue in 60 mL of glacial acetic acid, add crystal violet TS, and titrate with 0.1 N perchloric acid VS. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 28.21 mg of C20H24ClN3S·C2H6O6S2.
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 3396
Pharmacopeial Forum: Volume No. 29(5) Page 1565
Chromatographic Column—
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.