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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USP32NF27 Page 2422Pharmacopeial Forum: Volume No. 29(6) Page 1887