(proe'' klor per' a zeen e dis' i late).
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
[noteThroughout 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 IdentificationOrganic 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.
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USP35NF30 Page 4429Pharmacopeial Forum: Volume No. 29(5) Page 1565