Fluphenazine Hydrochloride

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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C₂₂H₂₆F₃N₃OS · 2HCl 510.44

1-Piperazineethanol, 4-[3-[2-(trifluoromethyl)-10H- phenothiazin-10-yl]propyl]-, dihydrochloride;

4-[3-[2-(Triuoromethyl)phenothiazin-10-yl]propyl]-1- piperazineethanol dihydrochloride CAS RN®: 146-56-5; UNII: ZOU145W1XL.

1 DEFINITION

Fluphenazine Hydrochloride contains NLT 97.0% and NMT 103.0% of fluphenazine hydrochloride (C₂₂H₂₆F₃N₃OS · 2HCl), calculated on the dried basis.

[Note—Throughout the following procedures, protect samples, the Reference Standard, and solutions containing them by conducting the procedures without delay, under subdued light, or using low-actinic glassware.]

2 IDENTIFICATION

Change to read:

A. Spectroscopic Identification Tests 〈197〉, Infrared Spectroscopy: 197K (CN 1-May-2020)

Change to read:

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

Analytical wavelength: 259 nm

Sample solution: 10 µg/mL of Fluphenazine Hydrochloride in methanol

Acceptance criteria: Absorptivities, calculated on the dried basis, do not differ by more than 2.5%.

C. Identification Tests—General, Chloride〈191〉: Meets the requirements

3 ASSAY

Procedure

Buffer: 0.05 M monobasic potassium phosphate adjusted with phosphoric acid to a pH of 2.5

Diluent: Acetonitrile, methanol, and Buffer (30:30:40)

Mobile phase: 0.2% triethylamine in Diluent

Standard solution: 0.06 mg/mL of USP Fluphenazine Hydrochloride RS in Diluent

Sample stock solution: 1.2 mg/mL of Fluphenazine Hydrochloride in Diluent

Sample solution: 0.06 mg/mL of Fluphenazine Hydrochloride from Sample stock solution in Diluent. Filter, and discard the first 5 mL of the filtrate.

3.1 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4-mm × 12.5-cm; packing L7

Flow rate: 1 mL/min

Injection volume: 25 µL

3.2 System suitability

Sample: Standard solution

Suitability requirements

Column efficiency: NLT 2000 theoretical plates

Tailing factor: NMT 2.0

Relative standard deviation: NMT 2.0%

3.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of fluphenazine hydrochloride (C₂₂H₂₆F₃N₃OS · 2HCl) in the portion of Fluphenazine Hydrochloride taken:

Result = (r_U /r_S) × (C_S /C_U) × 100

r_U = peak response from the Sample solution

r_S = peak response from the Standard solution

C_S = concentration of USP Fluphenazine Hydrochloride RS in the Standard solution (mg/mL)

C_U = concentration of Fluphenazine Hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 97.0%–103.0% on the dried basis

4 IMPURITIES

Residue on Ignition 〈281〉: NMT 0.5%

Ordinary Impurities 〈466〉

Standard solution and Test solution: 0.1 M methanolic sodium hydroxide

Eluant: Acetone, cyclohexane, and diethylamine (40:15:1)

Visualization: 1

Acceptance criteria: Meets the requirements

5 SPECIFIC TESTS

Loss on Drying 〈731〉

Analysis: Dry at 65° for 3 h.

Acceptance criteria: NMT 1%

6 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in tight, light-resistant containers.

USP Reference Standards 〈11〉

USP Fluphenazine Hydrochloride RS.