Fluphenazine Enanthate
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Heptanoic acid,2-[4-[3-[2-(trifluoromethyl)-10H-phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl ester.
2-[4-[3-[2-(Trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl heptanoate [2746-81-8].
»Fluphenazine Enanthate contains not less than 97.0percent and not more than 103.0percent of C29H38F3N3O2S,calculated on the dried basis.
Packaging and storage—
Preserve in tight,light-resistant containers.
USP Reference standards á11ñ—
USP Fluphenazine Enanthate Dihydrochloride RS.
NOTE—Throughout the following procedures,protect test or assay specimens,the USP Reference Standard,and solutions containing them,by conducting the procedures without delay,under subdued light,or using low-actinic glassware.
Identification—
A:
Place about 50mg of Fluphenazine Enanthate and about 50mg of USP Fluphenazine Enanthate Dihydrochloride RSin separate,glass-stoppered,small centrifuge tubes,and treat each tube as follows.Add 1.5mLof sodium hydroxide solution (1in 250),and mix.Add 2mLof carbon disulfide,shake vigorously for 2minutes,and centrifuge.Dry the lower,clear layer by filtering it through 2g of anhydrous sodium sulfate:the IRabsorption spectrum of the test preparation,determined in a 0.1-mm cell,exhibits maxima only at the same wavelengths as that of the Standard preparation,similarly measured.
B:
Ultraviolet Absorption á197Uñ—
Solution:
10µg per mL.
Medium:
methanolic hydrochloric acid (8.5in 1000).
Absorptivities at 258nm,calculated on the dried basis,do not differ by more than 2.5%.
Loss on drying á731ñ—
Dry it in vacuum at 60
for 3hours:it loses not more than 1.0%of its weight.
for 3hours:it loses not more than 1.0%of its weight.
Residue on ignition á281ñ:
not more than 0.2%.
Heavy metals,Method IIá231ñ:
0.003%.
Ordinary impurities á466ñ—
Test solution:
alcohol.
Standard solution:
alcohol.
Eluant:
a mixture of alcohol,glacial acetic acid,and water (3:1:1).
Visualization:
1.
Assay—
Dissolve about 500mg of Fluphenazine Enanthate,accurately weighed,in 50mLof glacial acetic acid,add 1drop of crystal violet TS,and titrate with 0.1Nperchloric acid VSto a blue-green endpoint.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 27.49mg of C29H38F3N3O2S.
Auxiliary Information—
Staff Liaison:Ravi Ravichandran,Ph.D.,Senior Scientist
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 859
Pharmacopeial Forum:Volume No.29(6)Page 1887
Phone Number:1-301-816-8330