CAS Number 54143-56-5, Flecainide Acetate JP USP IP BP Ph Eur EP Grade Manufacturers Exporters
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CAS Number 54143-56-5, Flecainide Acetate JP USP IP BP Ph Eur EP Manufacturer Exporter
For Properties Specifications of Flecainide Acetate Click Properties, Specifications of Flecainide Acetate Manufacturer.
For Uses of Flecainide Acetate Click Uses of Flecainide Acetate Manufacturer.
For For SDS MSDS Sheet of Flecainide Acetate Click SDS Safety Data Sheet MSDS Sheet of Flecainide Acetate Manufacturer.
The Properties and Specifications of Flecainide Acetate:
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.
TESTS
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.
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.
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.
We also manufacture Flecainide Acetate EP IP JP Grade.
The Uses of Flecainide Acetate:
Flecainide is used to prevent and treat abnormally fast heart rates.
The MSDS-SDS Hazard Statement of Flecainide Acetate:
Flecainide Acetate SDS, Safety Data Sheet
MSDS Sheet, Material safety Data Sheet 18-Nov-24
1. Product Identification
Product Name & Other Names: Flecainide Acetate.
CAS No.: 54143-56-5
EINECS: EC Number: 258-997-5
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Acute toxicity, Oral (Category 4), (H302)
Skin irritation (Category 2), (H315)
Eye irritation (Category 2), (H319)
Specific target organ toxicity - single exposure Category 3, (H335)
Reproductive toxicity Category 1B, (H360FD)
Labeling according to Regulation (EC) No 1272/2008
GHS Label Elements  Health Hazard |
GHS Label Elements |
Signal word: Danger
Hazard statements:
H302 Harmful if swallowed.
H315 Causes skin irritation.
H319 Causes serious eye irritation.
H335 May cause respiratory irritation.
H360FD: May damage fertility. May damage the unborn child.
Precautionary statements:
P210: Keep away from heat/sparks/open flames/hot surfaces – No smoking.
P261 Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray.
P270: Do not eat, drink, or smoke when using this product.
P280 Wear protective gloves/ eye protection/ face protection.
P301+P312: IF SWALLOWED: Call a POISON CENTER or doctor/ physician if you feel unwell.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
3. Composition/Information on Ingredients
Product Name & Other Names: Flecainide Acetate.
CAS No.: 54143-56-5
EINECS: EC Number: 258-997-5
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: Wipe off excess material from skin then immediately flush skin with plenty of water for at least 15 minutes. Remove contaminated clothing and shoes. Get medical attention. Wash clothing before reuse. Thoroughly clean shoes before reuse.
Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids occasionally. Get medical attention immediately.
5. Fire Fighting Measures
Flammability of the Product: It is an organic combustible material.
Products of Combustion: It emits Carbon oxides, Nitrogen oxides, Fluorine compounds and fumes when heated to decomposition.
Fire Extinguishing Media: Water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode.
6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage:
Small Spill: Eliminate all sources of ignition. Avoid dust-mist formation. Avoid breathing dust. Ensure adequate ventilation. Use appropriate tools to put the spilled material in a convenient waste disposal container.
Large Spill: Eliminate all sources of ignition. Do not inhale dust, vapors, mist, or gas. Avoid dust formation. Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Use a shovel to put the material into a convenient waste disposal container.
7. Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. In case of insufficient ventilation, wear suitable respiratory equipment. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Store protected from heat, sparks and ignition sources and incompatible materials. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Storage: Preferably 2C to 8C.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: No adequate information found.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to dust or mist is apparent and engineering controls are not feasible, a particulate respirator may be worn.
Skin Protection: Wear protective gloves and clean body-covering clothing.
Eye Protection: Use chemical safety goggles and/or full-face shield where dusting or splashing of solutions is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice.
9. Physical and Chemical Properties
Appearance: White to off-white crystalline powder.
Odor: No data found.
Odor threshold: No data found.
pH: No data found.
Relative density: No data found.
Boiling Point: 435C.
Melting Point: 146C to 152C literature.
Flash Point: No data found.
Auto-ignition temperature: No data found.
Decomposition temperature: No data found.
Upper/lower flammability or explosive limits: No data found.
Vapor pressure: No data found.
Vapor density: No data found.
Evaporation rate: No data found.
Flammability (solid, gas): No data found.
Partition coefficient: n-octanol/water: No data found.
Solubility: Soluble in water. Freely soluble in alcohol.
Viscosity: No data found.
10. Stability and Reactivity
Stability: Stable under ordinary conditions of use and storage. Hygroscopic, Air sensitive, Light sensitive.
Hazardous Decomposition Products: It emits Carbon oxides, Nitrogen oxides, Fluorine compounds and fumes when heated to decomposition.
Hazardous Polymerization: Will not occur.
Incompatibilities: Strong oxidizing agents and Heat.
Conditions to Avoid: Moisture, Heat, Incompatibles.
11. Toxicological Information
Toxicity to Animals:
ORAL (LD50): 1346 mg/kg (Rat).
Carcinogenic Effects: Not a reported carcinogen.
Mutagenic Effects: No data found.
Teratogenic Effects: No data found.
Developmental Toxicity: May damage fertility. May damage the unborn child.
12. Ecological Information
Environmental Toxicity: No data found.
Results of PBT and vPvB assessment: This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.
13. Disposal Considerations
Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Follow all the pollution control laws.
14. Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods.
IMDG/IMO: Not dangerous goods.
IATA: Not dangerous goods.
15. Regulatory Information
USA:
SARA 311/312 Hazards: See section 2.
California Prop. 65 Components: Not listed.
16. Other Information
Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is an off-shoot of Anmol Chemicals Taloja. It is located in MIDC Taloja and it is manufacturing pharmaceutical grades of API, Excepients, Food grade and Reagent grade chemicals. Anmol Chemicals & Pharmaceuticals Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies for actual users, retail or small pack supplies for research and development chemicals, fine and speciality chemicals, pharmaceutical excipients, mineral fortifiers in chemically pure, Analytical reagent grade, IP BP USP Ph Eur EP JP and other pharmaceutical grade monograph including FCC Food grade chemicals and Nutraceuticals, Mineral Fortifiers at best prices.
Flecainide Acetate Structure
CAS Number 54143-56-5, Flecainide Acetate Manufacturer Exporter
ANMOL CHEMICALS & PHARMACEUTICALS Pvt. Ltd.
India, USA, Europe, UAE
TELEPHONE: +912223770100
Navi Mumbai, INDIA
e-mail: info(At the rate i.e. @)anmol.org
Copyright. 25-nov-24
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