Flecainide Acetate IP BP Ph Eur EP USP Grade Manufacturers, with SDS GHS MSDS Sheet |
Supplier, Manufacturer, Exporter of Flecainide Acetate, Muby Chemicals of Mubychem Group, established in 1976, is the original manufacturers of Specialty Chemicals, Pharmaceutical Excipient, Fragrance Food & Flavor chemicals, Reagent Grade Chemicals, Shale Gas Fracturing Chemicals in India. Mubychem Group has several manufacturing facilities spread across Western India and world wide contacts and toll manufacturers. We are exporting globally to countries like USA, Canada, Europe, UAE, South Africa, Tanzania, Kenya, Egypt, Nigeria, Cameroon, Uganda, Turkey, Mexico, Brazil, Chile, Argentina, Dubai, Korea, Vietnam, Thailand, Malaysia, Indonesia, Australia, China, Germany, France, Italy, Portugal, Bangladesh, etc. The products are offered as per required specifications and in correct shape and size in mm or meshs or microns as specified by the buyer. The participating units have one or more accreditations like FDA - cGMP and GLP approval, ISO-9001 Certified, "REACH" Registered, ISO-14001, ISO/IEC 17025, ISO-22000, FSSC 22000, ISO 45001, Kosher Certified, Halal Certified, HACCP, FSSAI. We offer Commercial Pure & IP BP EP Ph Eur USP NF JP FCC Food Grade Analytical Reagent Grades of Chemicals |
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Flecainide Acetate CAS Number 54143-56-5, EINECS EC Number: 258-997-5, Molecular Formula: C19H24F6N2O5, Molecular Weight: 474.39, HS Code 29333990 or 29225090 or 30049079
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SDS MSDS Sheet of Flecainide Acetate Manufacturers
Flecainide Acetate
IP BP EP Ph Eur USP Grade Suppliers
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.
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.
Storage: In an airtight container, protected from light.
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.
We also manufacture and supply as under:
Manufacturers:
MUBY CHEMICALS
Ambernath Mumbai, Ankleshwar Gujarat, India
TEL: (OFFICE) +912223770100, +912223726950
Current Date Time in India GMT+5:30
e-mail: info@mubychem.com
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25 April, 2024
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Flecainide Acetate SDS, Safety Data Sheet
MSDS Sheet, Material safety Data Sheet 22-Jan-23
1. Product Identification
Product Name & Other Names: Flecainide Acetate.
CAS No.: 54143-56-5
EINECS: EC Number: 258-997-5
Molecular Weight: 474.39
Chemical Formula: C19H24F6N2O5
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.
P264: Wash … thoroughly after handling.
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.
P308+313: IF exposed or concerned: Get medical advice/attention.
P501: Dispose of contents/container to an authorized agent only.
Classification according to Directive 67/548/EEC or Directive 1999/45/EC:
Hazard Symbol:
Xn = Harmful.
Xi = Irritant.
Risk Phrase:
R22 Harmful if swallowed.
R36/37/38 Irritating to eyes, respiratory system, and skin.
R61: May cause harm to the unborn child.
R62-22: Possible risk of impaired fertility. Harmful if swallowed.
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.
Note to Physician: Symptomatic and supportive treatment is recommended.
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. At high temperatures under fire conditions, it may produce toxic or irritating fumes. Fire-extinguishing work is done from the windward and a suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.
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.). Restrict unprotected personnel from the area. Prevent any contact with hot surfaces. Do not approach facing the wind. Do not touch the spilled material.
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. Finish cleaning by spreading water on the contaminated surface and disposing of it according to local and regional authority requirements. Beware of vapors accumulating to form explosive concentrations. Vapors can accumulate in low areas.
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. Finish cleaning by spreading water on the contaminated surface and allow to evacuate as per law.
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.). Prevent any contact with hot surfaces.
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 contact with skin and eyes. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like strong oxidizing agents. Storage: Preferably 2C to 8C. OK to freeze.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: No adequate information found. Better keep it below 10 ppm.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible. Local exhaust ventilation is generally preferred because it can control the emissions of the contaminant at its source, preventing dispersion of it into the general work area.
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. For emergencies or instances where the exposure levels are not known, use a full-face positive-pressure, air-supplied respirator.
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. Wash hands after handling.
9. Physical and Chemical Properties
Appearance: White to off-white crystalline powder.
Odor: Not available.
Odor threshold: Not available.
pH: Not available.
Relative density: Not available.
Boiling Point: 435C.
Melting Point: 146C to 152C literature.
Flash Point: Not available.
Auto-ignition temperature: Not available.
Decomposition temperature: Not available.
Upper/lower flammability or explosive limits: Not available.
Vapor pressure: Not available.
Vapor density: Not available.
Evaporation rate: Not available.
Flammability (solid, gas): Not available.
Partition coefficient: n-octanol/water: Not available.
Solubility: Soluble in water. Freely soluble in alcohol.
Viscosity: Not available.
Molecular Weight: 474.39
Chemical Formula: C19H24F6N2O5
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: Not available.
Teratogenic Effects: Not available.
Developmental Toxicity: May damage fertility. May damage the unborn child.
12. Ecological Information
BOD5 and COD: Not available.
Environmental Toxicity: Not available.
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. Processing use or contamination of this product may change the waste management options. State and local disposal regulations may differ from federal disposal regulations. Dispose of containers and unused contents in accordance with federal, state, and local requirements. Small amounts of this material may be suitable for sanitary sewer or trash disposal.
14. Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IMDG/IMO: Not regulated.
IATA: Not regulated.
15. Regulatory Information
USA:
SARA 311/312 Hazards: Immediate (Acute) Health Hazard. See section 2.
California Prop. 65 Components: This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm.
16. Other Information
European Labeling in Accordance with EC Directives:
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.
Hazard Symbol:
Xn = Harmful.
Xi = Irritant.
Risk Phrase:
R22 Harmful if swallowed.
R36/37/38 Irritating to eyes, respiratory system, and skin.
R61: May cause harm to the unborn child.
R62-22: Possible risk of impaired fertility. Harmful if swallowed.
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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