Fluphenazine Hydrochloride Injection

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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1 DEFINITION

Fluphenazine Hydrochloride Injection is a sterile solution of Fluphenazine Hydrochloride in Water for Injection. It contains NLT 95.0% and NMT 110.0% of the labeled amount of fluphenazine hydrochloride (C₂₂H₂₆F₃N₃OS · 2HCl).

[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

A. Thin-Layer Chromatography

Diluent: Methanol and water (80:20)

Standard solution: 20 mg/mL of USP Fluphenazine Hydrochloride RS in Diluent prepared as follows. Transfer 10 mg of USP Fluphenazine Hydrochloride RS to a separator, and add 20 mL of 6 N sodium hydroxide. Extract the resulting mixture with 20 mL of isooctane. Evaporate the isooctane solution to dryness, and dissolve the residue in 0.5 mL of Diluent.

Sample solution: Nominally 20 mg/mL of fluphenazine hydrochloride from Injection in Diluent prepared as follows. Transfer a volume of Injection, equivalent to 10 mg of fluphenazine hydrochloride, to a separator, and add 20 mL of 6 N sodium hydroxide. Extract the resulting mixture with 20 mL of isooctane. Evaporate the isooctane solution to dryness, and dissolve the residue in 0.5 mL of Diluent.

2.1 Chromatographic system

(See Chromatography 〈621〉, Thin-Layer Chromatography.)

Adsorbent: 0.25-mm layer of chromatographic silica gel mixture

Application volume: 10 µL

Developing solvent system: Acetone, cyclohexane, and diethylamine (40:15:1)

Spray reagent: Sulfuric acid in methanol (2 in 5)

2.2 Analysis

Samples: Standard solution and Sample solution

Allow the spots to dry, and develop the chromatogram in the Developing solvent system until the solvent front has moved three-fourths of the length of the plate. Locate the spots on the plate by lightly spraying it with Spray reagent.

Acceptance criteria: The R value and color of the principal spot of the Sample solution correspond to those of the Standard solution. F

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 solution: Nominally 0.06 mg/mL of fluphenazine hydrochloride from Injection in Diluent prepared as follows. Transfer a suitable volume of Injection, equivalent to 6 mg of fluphenazine hydrochloride, to a 100-mL volumetric ask using a “to contain” pipet. Rinse the pipet with Diluent to complete the transfer, and dilute with Diluent to volume. Filter, and use the filtrate after discarding 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 the labeled amount of fluphenazine hydrochloride (C₂₂H₂₆F₃N₃OS · 2HCl) in the portion of Injection 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 = nominal concentration of fluphenazine hydrochloride in the Sample solution (mg/mL)

Acceptance criteria: 95.0%–110.0%

4 SPECIFIC TESTS

pH 〈791〉: 4.8–5.2

Bacterial Endotoxins Test 〈85〉: NMT 166.7 USP Endotoxin Units/mg of fluphenazine hydrochloride

Other Requirements: It meets the requirements in Injections and Implanted Drug Products 〈1〉.

5 ADDITIONAL REQUIREMENTS

Packaging and Storage: Preserve in single-dose or multiple-dose containers, preferably of Type I glass, and protect from light.

USP Reference Standards 〈11〉

USP Fluphenazine Hydrochloride RS