(floo fen' a zeen e nan' thate).
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 97.0 percent and not more than 103.0 percent of C29H38F3N3O2S, calculated on the dried basis.
Packaging and storage Preserve in tight, light-resistant containers.
USP Reference standards 11
USP Fluphenazine Enanthate Dihydrochloride RS
[NoteThroughout 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. ]
A: Place about 50 mg of Fluphenazine Enanthate and about 50 mg of USP Fluphenazine Enanthate Dihydrochloride RS in separate, glass-stoppered, small centrifuge tubes, and treat each tube as follows. Add 1.5 mL of sodium hydroxide solution (1 in 250), and mix. Add 2 mL of carbon disulfide, shake vigorously for 2 minutes, and centrifuge. Dry the lower, clear layer by filtering it through 2 g of anhydrous sodium sulfate: the IR absorption 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 197U
Solution: 10 µg per mL.
Medium: methanolic hydrochloric acid (8.5 in 1000).
Absorptivities at 258 nm, calculated on the dried basis, do not differ by more than 2.5%.
Loss on drying 731 Dry it in vacuum at 60 for 3 hours: it loses not more than 1.0% of its weight.
Residue on ignition 281: not more than 0.2%.
Heavy metals, Method II 231: 0.003%.
Ordinary impurities 466
Test solution: alcohol.
Standard solution: alcohol.
Eluant: a mixture of alcohol, glacial acetic acid, and water (3:1:1).
Assay Dissolve about 500 mg of Fluphenazine Enanthate, accurately weighed, in 50 mL of glacial acetic acid, add 1 drop of crystal violet TS, and titrate with 0.1 N perchloric acid VS to a blue-green endpoint. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 27.49 mg of C29H38F3N3O2S.
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USP35NF30 Page 3250Pharmacopeial Forum: Volume No. 29(6) Page 1887