Prochlorperazine
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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 98.0percent and not more than 101.0percent of C20H24ClN3S.
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—
It meets the requirements under Identification—Organic Nitrogenous Bases á181ñ,USP Prochlorperazine Maleate RSbeing used as the standard for comparison.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
Test solution:
methanol.
Standard solution:
methanol.
Eluant:
a mixture of methanol and ammonium hydroxide (100:1).
Visualization:
1.
Assay—
Transfer about 400mg of Prochlorperazine,accurately weighed,to a 125-mLconical flask,add 30mLof glacial acetic acid,and warm on a steam bath to dissolve.Add 2drops of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 18.70mg of C20H24ClN3S.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1631
Phone Number:1-301-816-8251