Flecainide Acetate

Flecainide is a medication used to prevent and treat abnormally fast heart rates.:

General Properties and Specifications of Flecainide Acetate or Tambocor:
Appearance: White to off-white crystalline powder.
Assay on dried basis: 98% to 102%
Acetate content: 12.4% to 12.8%
Identifications: IR, UV and HPLC.
Loss on drying: 0.5% maximum. Drying under vacuum at a pressure of 5mm mercury @ 60C for 2 hr.
Residue on ignition: 0.2% maximum.
Impurities:
Flecainide acid: 0.5% maximum.
Flecainide related compound A: 0.5% maximum.
Flecainide pyridine analogue: 0.5% maximum.
Any individual unspecified impurity: 0.1% maximum.
Total impurities: 2% maximum.
Residual solvent:
Acetone: 5000 ppm maximum.
Ethyl acetate: 5000 ppm maximum.
Toluene: 890 ppm maximum.
N, N-Dimethylformamide: 880 ppm maximum.
2,2,2-Trifluroethanol: 1000 ppm maximum.
Triethylamine: 5000 ppm maximum.
Melting Point: 146C to 152C literature.
Boiling Point: 435C.
Solubility: Soluble in water. Freely soluble in alcohol.
Storage: Preferably 2C to 8C. OK to freeze.

Storage: Preferably 2C to 8C. OK to freeze. Protected from light.

Flecainide Acetate USP Grade Specifications:
C17H20F6N2O3-C2H4O2 --- 474.39
Benzamide,
N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-, monoacetate.
N-(2-Piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate CAS 54143-56-5

UNII: M8U465Q1WQ
UNII: K94FTS1806
Flecainide Acetate contains not less than 98.0 percent and not more than 101.0 percent of C17H20F6N2O3-C2H4O2 , calculated on the dried basis.
Packaging and storage: Preserve in well-closed containers.

Clarity of solution: Prepare a test solution by placing 250 mg of it in a test tube about 18 mm in diameter, adding 10 mL of water and 1 drop of glacial acetic acid, and shaking to dissolve it. The solution is colorless and is not less clear than an equal volume of water in a similar test tube.
Identification:
A: Infrared Absorption
B: Ultraviolet Absorption
Melting range: between 146C and 152C, but the range between beginning and end of melting does not exceed 3C.
Loss on drying: Dry it in a vacuum at a pressure not exceeding 5 mm of mercury at 60C for 2 hours: it loses not more than 0.5% of its weight.
Residue on ignition: not more than 0.2%.
Chromatographic purity: To pass the test.

Flecainide Acetate BP Ph Eur Grade Specifications:
C19H24F6N2O5 --- 474.4 --- 54143-56-5
Action and use: Class I antiarrhythmic.

DEFINITION
N-[(RS)-(Piperidin-2-ylmethyl)]-2,5-bis(2,2,2-trifluoroethoxy)benzamide acetate.
Content: 98.0 per cent to 101.0 per cent (dried substance).

IDENTIFICATION
First identification: A, C
Second identification: A, B, D
A. Melting point: 146C to 152C, with a melting range not greater than 3C.
B. Ultraviolet and visible absorption spectrophotometry.
C. Infrared absorption spectrophotometry.
D. It gives reaction of acetates.

IDENTIFICATION
First identification: A, C
Second identification: A, B, D
A. Melting point: 146C to 152C, with a melting range not greater than 3C.
B. Ultraviolet and visible absorption spectrophotometry.
C. Infrared absorption spectrophotometry.
D. It gives reaction of acetates.

For Original Monographs of IP Indian Pharmacopoeia EP Ph Eur European Pharmacopoeia BP British Pharmacopoeia USP US Pharmacopoeia FCC Food Grade product, please check with the respective web-pages or books.