Flecainide Acetate Oral Suspension
Flecainide Acetate Oral Suspension contains NLT 90.0% and NMT 110.0% of the labeled amount of flecainide acetate (C17H20F6N2O3·C2H4O2).
Prepare Flecainide Acetate Oral Suspension 20 mg/mL as follows (see Pharmaceutical CompoundingNonsterile 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.
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.
Detector: UV 280 nm
Column: 4.6-mm × 25-cm; 5-µm packing L1
Column temperature: 40
Flow rate: 1.0 mL/min
Injection size: 20 µL
Sample: Standard solution
Relative standard deviation: NMT 2.0% for replicate injections
Samples: Standard solution and Sample solution
Calculate the percentage of the labeled amount of flecainide acetate (C17H20F6N2O3·C2H4O2) in the portion of Oral Suspension taken:
Result = (rU/rS) × (CS/CU) × 100
Acceptance criteria: 90.0%110.0%
• pH 791: 3.84.8
• Packaging and Storage: Package in tight, light-resistant containers. Store at controlled room temperature or controlled cold temperature.
• Labeling: Label it to indicate that it is to be well-shaken before use, protected from light, and to state the Beyond-Use Date.
• Beyond-Use Date: NMT 60 days after the date on which it was compounded when stored at controlled room temperature or when stored at controlled cold temperature
• USP Reference Standards 11
USP Flecainide Acetate RS
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USP35NF30 Page 3201Pharmacopeial Forum: Volume No. 36(2) Page 401