2/14/25, 4:45 PM USP-NF Fluphenazine Decanoate
Status: Currently Official on 14-Feb-2025
Official Date: Official as of 01-May-2024
Document Type: USP Monographs
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Fluphenazine Decanoate
Change to read:
C32H44F3N3O2S ▲591.78
▲ (CN 1-May-2024)
Decanoic acid, 2-[4-[3-[2-(trifluoromethyl)-10H-decanoate phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl ester;
2-[4-[3-[2-(Trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazinyl]ethyl decanoate CAS RN®: 5002-47-1; UNII: FMU62K1L3C.
DEFINITION
Fluphenazine Decanoate contains NLT 98.0% and NMT 102.0% of fluphenazine decanoate (C32H44F3N3O2S), calculated on the dried basis.
[Note—Throughout the following procedures, protect samples, the Reference Standard, and solutions containing them by conducting the
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procedures without delay under subdued light, or using low-actinic glassware.]
IDENTIFICATION
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• A. Infrared Absorption
Solution A: Sodium hydroxide solution (1 in 250)
Standard solution: Transfer 50 mg of USP Fluphenazine Decanoate Dihydrochloride RS to a glass-stoppered, small centrifuge tube, and add
1.5 mL of Solution A. Add 2 mL of carbon disulfide, shake vigorously for 2 min, and centrifuge. Dry the lower, clear layer by filtering through
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2 g of anhydrous sodium sulfate. Use the filtrate.
Sample solution: Transfer 50 mg of Fluphenazine Decanoate to a glass-stoppered, small centrifuge tube, and add 1.5 mL of Solution A. Add 2
mL of carbon disulfide, shake vigorously for 2 min, and centrifuge. Dry the lower, clear layer by filtering through 2 g of anhydrous sodium
sulfate. Use the filtrate.
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Instrumental conditions
Mode: IR
Cell: 0.1 mm
Acceptance criteria: The absorption spectrum of the Sample solution exhibits maxima only at the same wavelengths as that of the Standard
solution.
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• B. Thin-Layer Chromatography
Standard solution: 22.5 mg/mL of USP Fluphenazine Decanoate Dihydrochloride RS (equivalent to 20 mg/mL of fluphenazine decanoate) in
alcohol
Sample solution: 20 mg/mL of Fluphenazine Decanoate in alcohol
Chromatographic system
(See Chromatography 〈621〉, Thin-Layer Chromatography.)
Adsorbent: 0.25-mm layer of chromatographic silica gel mixture. Impregnate the plate with a 1-in-20 solution of tetradecane in hexane, and
allow to air-dry.
Application volume: 1 µL
Developing solvent system: Methanol and water (90:10)
Analysis
Samples: Standard solution and Sample solution
Apply the Standard solution and the Sample solution to the plate. Allow the spots to dry. Apply 1.0 µL of 0.1 N sodium hydroxide to the
spot from the Standard solution, and allow it to dry. Develop the plate in an equilibrated chamber using the Developing solvent system.
Examine the plate under short-wavelength UV light at 254 nm.
Acceptance criteria: The RF value of the principal spot of the Sample solution corresponds to that of the Standard solution.
ASSAY
• Procedure
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2/14/25, 4:45 PM USP-NF Fluphenazine Decanoate
Sample: 500 mg of Fluphenazine Decanoate
Blank: 50 mL of glacial acetic acid
Titrimetric system
Mode: Direct titration
Titrant: 0.1 N perchloric acid VS
Endpoint detection: Visual
Analysis: Dissolve the Sample in 50 mL of glacial acetic acid, add one drop of crystal violet TS, and titrate with Titrant to a blue-green
endpoint. Perform the Blank determination, and make any necessary correction.
Calculate the percentage of fluphenazine decanoate (C32H44F3N3O2S) in the portion of Fluphenazine Decanoate taken. Each mL of 0.1 N
perchloric acid is equivalent to 29.59 mg of fluphenazine decanoate (C32H44F3N3O2S).
Acceptance criteria: 98.0%–102.0% on the dried basis
IMPURITIES
• Residue on Ignition 〈281〉: NMT 0.2%
• Ordinary Impurities 〈466〉
Test solution and Standard solution: Methanol
Eluant: Acetone, cyclohexane, and ammonium hydroxide (16:6:1)
Visualization: 1; then spray the plate with 50% sulfuric acid.
Acceptance criteria
Individual impurity: NMT 1.0%
Total impurities: NMT 2.0%
SPECIFIC TESTS
• Loss on Drying 〈731〉
Analysis: Dry under vacuum at 60° for 3 h.
Acceptance criteria: NMT 1.0%
ADDITIONAL REQUIREMENTS
• Packaging and Storage: Preserve in tight, light-resistant containers.
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IA
• USP Reference Standards 〈11〉
USP Fluphenazine Decanoate Dihydrochloride RS
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Auxiliary Information - Please check for your question in the FAQs before contacting USP.
Topic/Question Contact Expert Committee
FLUPHENAZINE DECANOATE Documentary Standards Support SM42020 Small Molecules 4
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Chromatographic Database Information: Chromatographic Database
Most Recently Appeared In:
Pharmacopeial Forum: Volume No. 49(4)
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