Flecainide Acetate Compounded Oral Suspension

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

Flecainide Acetate Compounded Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of ecainide acetate (C₁₇H₂₀F₆N₂O₃ · C₂H₄O₂).

Prepare Flecainide Acetate Compounded Oral Suspension 20 mg/mL as follows (see Pharmaceutical Compounding—Nonsterile Preparations 〈795〉):

Calculate the required quantity of each ingredient for the total amount to be prepared. If using tablets, place the required number in a suitable mortar, and comminute to a fine powder with a pestle, or use Flecainide Acetate powder. Add the Vehicle in small portions, and triturate to make a smooth paste. Add increasing volumes of the Vehicle to make a flecainide acetate liquid that is pourable. Transfer the contents of the mortar, stepwise and quantitatively, to a calibrated bottle. Add enough of the liquid Vehicle to bring to final volume, and mix well.

2 ASSAY

2.1 Procedure

Mobile phase: Acetonitrile and 0.06% phosphoric acid solution (40:60)

Standard stock solution: 1.0 mg/mL of USP Flecainide Acetate RS in Mobile phase

Standard solution: Transfer 2 mL of Standard stock solution to a 10-mL volumetric flask, and dilute with Mobile phase to volume to obtain a solution containing about 200 μg/mL of flecainide acetate.

Sample solution: Agitate the container of Oral Suspension for 30 min on a rotating mixer, remove a 5-mL sample, and store in a clear glass vial at −70° until analyzed. At the time of analysis, remove the sample from the freezer, allow it to reach room temperature, and mix with a vortex mixer for 30 s. Pipet 1.0 mL of the sample into a 100-mL volumetric flask, and dilute with Mobile phase to volume to obtain a solution having a nominal concentration of about 200 μg/mL.

2.2 Chromatographic system

(See Chromatography 〈621〉, System Suitability.)

Mode: LC

Detector: UV 280 nm

Column: 4.6-mm × 25-cm; 5-μm packing L1

Column temperature: 40°

Flow rate: 1.0 mL/min

Injection volume: 20 μL

2.3 System suitability

Sample: Standard solution

2.4 Suitability requirements

Relative standard deviation: NMT 2.0% for replicate injections

2.5 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of ecainide acetate (C₁₇H₂₀F₆N₂O₃ · C₂H₄O₂) in the portion of Oral Suspension 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 Flecainide Acetate RS in the Standard solution (μg/mL)

C_U = nominal concentration of flecainide acetate in the Sample solution (μg/mL)

Acceptance criteria: 90.0%–110.0%

3 SPECIFIC TESTS

pH 〈791〉: 3.8–4.8

4 ADDITIONAL REQUIREMENTS

Packaging and Storage: Package in tight, light-resistant containers. Store at controlled room temperature or in a refrigerator.

Beyond-Use Date: NMT 60 days after the date on which it was compounded when stored at controlled room temperature or when stored in a refrigerator

Labeling: Label it to indicate that it is to be well-shaken before use, protected from light, and to state the Beyond-Use Date.

USP Reference Standards 〈11〉

USP Flecainide Acetate RS