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Flecainide Acetate USP NF EP BP Ph Eur IP Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Flecainide Acetate and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
All technical documents and DMF support available.
Flecainide Acetate SDS of Manufacturers
Synonyms: Flecainide Acetate
CAS Number: 54143-56-5, Molecular Weight: 474.39, Chemical Formula: C19H24F6N2O5, EINECS EC Number: 258-997-5, FEMA: ----,
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.
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).
CHARACTERS
Appearance: White or almost white, very hygroscopic, crystalline powder.
Solubility: Soluble in water and in anhydrous ethanol. It is freely soluble in dilute acetic acid and practically insoluble in dilute hydrochloric acid.
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.
Appearance of solution: The solution is clear and colourless.
Dissolve 0.50 g in water, add 0.1 mL of glacial acetic acid and dilute to 20 mL with water.
pH: 6.7 to 7.1.
Dissolve 0.25 g in carbon dioxide-free water and dilute to 10 mL with the same solvent.
Impurity B: To pass the test.
Related substances: To pass the test.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in an oven at 60C at a pressure not exceeding 0.6 kPa for 2 h.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g in a platinum crucible.
Storage: In an airtight container, protected from light.
Keywords: Flecainide Acetate IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 54143-56-5 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
Manufacturer Supplier Exporter
ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA
e-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated
26-feb-24
Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial and Laboratory Use only. No other use is permitted.
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Flecainide Acetate
IP BP Ph Eur EP USP NF Analytical Reagent FCC Food Grades Manufacturers