Fluphenazine Enanthate

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Fluphenazine Enanthate

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This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

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C29H38F3N3O2S              549.69

Heptanoic acid, 2-[4-[3-[2-(trifluoromethyl)-10H-pheno thiazin-10-yl]propyl]-1-piperazinyl]ethyl ester.

2-[4-[3-[2-(Triuoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl heptanoate CAS RN®: 2746-81-8; UNII: QSB34YF0W9.

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 C29H38F3N3O2S · 2HCl 622.63

[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 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.

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B: Spectroscopic Identication Tests 〈197〉, Ultraviolet-Visible Spectroscopy: 197U (CN 1-May-2020) —

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%.

Ordinary impurities 〈466〉—

Test solution: alcohol.

Standard solution: alcohol.

Eluant: a mixture of alcohol, glacial acetic acid, and water (3:1:1).

Visualization: 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 CC29H38F3N3O2S.

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