Flecainide Acetate Oral Suspension
DEFINITION
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 Compounding—Nonsterile Preparations 
795
):
795):| Flecainide Acetate | 2 g |
| Vehicle: a mixture of Vehicle for Oral Solution (regular or sugar-free), NF, and Vehicle for Oral Suspension, NF (1:1), a sufficient quantity to make | 100 mL |
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.
ASSAY
• 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.
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.
Chromatographic system
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 size:
20 µL
System suitability
Sample:
Standard solution
Suitability requirements
Relative standard deviation:
NMT 2.0% for replicate injections
Analysis
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
| rU | = | = peak response from the Sample solution |
| rS | = | = peak response from the Standard solution |
| CS | = | = nominal concentration of flecainide acetate in the Standard solution (µg/mL) |
| CU | = | = nominal concentration of flecainide acetate in the Sample solution (µg/mL) |
Acceptance criteria:
90.0%–110.0%
SPECIFIC TESTS
• pH 791:
3.8–4.8
791:
3.8–4.8
ADDITIONAL REQUIREMENTS
• 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
11
USP Flecainide Acetate RS
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Jeanne H. Sun
Assistant Scientific Liaison 1-301-816-3361 |
(CMP2010) Compounding |
| Reference Standards | RS Technical Services 1-301-816-8129 rstech@usp.org |
USP35–NF30 Page 3201
Pharmacopeial Forum: Volume No. 36(2) Page 401