Prochlorperazine Maleate
C20H24ClN3S·2C4H4O4
606.09
10H-Phenothiazine,2-chloro-10-[3-(4-methyl-1-piperazinyl)-propyl]-,(Z)-2-butenedioate (1:2).
2-Chloro-10-[3-(4-methyl-1-piperazinyl)propyl]phenothiazine maleate (1:2) [84-02-6].
»Prochlorperazine Maleate contains not less than 98.0percent and not more than 101.5percent of C20H24ClN3S·2C4H4O4,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
USP Reference standard 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,Infrared Absorption á197Kñ.
Loss on drying á731ñ—
Dry it in vacuum at 60
for 2hours:it loses not more than 0.5%of its weight.
for 2hours:it loses not more than 0.5%of its weight.
Residue on ignition á281ñ:
not more than 0.1%.
Ordinary impurities á466ñ—
Test solution:
a mixture of methanol and 1Nsodium hydroxide (9:1).
Standard solution:
a mixture of methanol and 1Nsodium hydroxide (9:1).
Eluant:
a mixture of methanol and ammonium hydroxide (100:1).
Visualization:
1.
Organic volatile impurities,Method Vá467ñ:
meets the requirements.
Solvent—
Use dimethyl sulfoxide.
Assay—
Transfer to a beaker about 400mg of Prochlorperazine Maleate,accurately weighed,and dissolve in 30mLof chloroform,warming on a steam bath to effect solution.Add 100mLof glacial acetic acid,cool to room temperature,and titrate with 0.05Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.05Nperchloric acid is equivalent to 15.15mg of C20H24ClN3S·2C4H4O4.
Auxiliary Information—
Staff Liaison:Elena Gonikberg,Ph.D.,Scientist
Expert Committee:(PA4)Pharmaceutical Analysis 4
USP28–NF23Page 1633
Phone Number:1-301-816-8251