Prochlorperazine Edisylate
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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 98.0percent and not more than 101.5percent of C20H24ClN3S·C2H6O6S2,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
USP Reference standards á11ñ—
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—
A:
It meets the requirements under Identification—Organic Nitrogenous Bases á181ñ,USP Prochlorperazine Maleate RSbeing used as the standard for comparison.
B:
Fuse about 100mg with a few pellets of sodium hydroxide:the cooled melt responds to the test for Sulfite á191ñ.
Loss on drying á731ñ—
Dry it in vacuum at 100
for 3hours:it loses not more than 0.5%of its weight.
for 3hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Selenium á291ñ:
0.003%,a 100-mg test specimen,mixed with 100mg of magnesium oxide,being used.
Ordinary impurities á466ñ—
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 2mLof chloroplatinic acid solution (1in 10)and 50mLof potassium iodide solution (4in 100).Dilute with water to 100mL,and acidify with 1Nhydrochloric acid.
Visualization:
1,followed by Spray reagent.
Organic volatile impurities,Method Iá467ñ:
meets the requirements.
Assay—
Transfer about 750mg of Prochlorperazine Edisylate,accurately weighed,to a separator containing 40mLof water,and shake to effect solution.Render the solution alkaline with ammonium hydroxide,and extract with three 25-mLportions of ether.Wash the combined ether extracts once with about 25mLof water,discard the washing,and evaporate the ether solution on a steam bath to dryness.Dissolve the residue in 60mLof glacial acetic acid,add crystal violet TS,and titrate with 0.1Nperchloric acid VS.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 28.21mg of C20H24ClN3S·C2H6O6S2.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1632
Pharmacopeial Forum:Volume No.29(5)Page 1565
Phone Number:1-301-816-8251