CAS Number 49562-28-9, Fenofibrate IP BP Ph Eur EP USP Grade Manufacturers Exporters
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CAS Number 49562-28-9, Fenofibrate IP BP Ph Eur EP USP Manufacturer Exporter
For Properties Specifications of Fenofibrate Click Properties, Specifications of Fenofibrate Manufacturer.
For Uses of Fenofibrate Click Uses of Fenofibrate Manufacturer.
For For SDS MSDS Sheet of Fenofibrate Click SDS Safety Data Sheet MSDS Sheet of Fenofibrate Manufacturer.
The Properties and Specifications of Fenofibrate:
Fenofibrate USP Grade Specifications:
C20H21ClO4 --- 360.83
Isopropyl 2-[p-(p-chlorobenzoyl)phenoxy]-2-methylpropanoate CAS 49562-28-9
UNII: U202363UOS
DEFINITION
Fenofibrate contains NLT 98.0% and NMT 102.0% of C20H21ClO4, calculated on the dried basis.
IDENTIFICATION
Infrared Absorption.
Residue on Ignition: NMT 0.1%, determined on 1.0 g.
Chloride and Sulfate, Chloride: It shows no more chloride than corresponds to 0.15 mL of 0.020 N hydrochloric acid (0.01%).
Chloride and Sulfate, Sulfate: It shows no more sulfate than corresponds to 0.15 mL of 0.020 N sulfuric acid (0.01%).
Organic Impurities: To pass the test by chromatography.
Melting Range or Temperature: 79C –82C.
Acidity:
Sample: 1.0 g
Analysis: Dissolve the Sample in 50 mL of alcohol previously neutralized to phenolphthalein and titrate with 0.1 N sodium hydroxide.
Acceptance criteria: NMT 0.2 mL is required to change the color of the indicator to pink.
Loss on Drying: Dry a sample in a vacuum over phosphorus pentoxide at 60C to constant weight. Acceptance criteria: NMT 0.5%
Color and Achromicity: To pass the test.
Fenofibrate BP Ph Eur Grade Specifications:
C20H21ClO4 --- 360.8 CAS 49562-28-9
DEFINITION
1-Methylethyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate.
Content: 98.0 per cent to 102.0 per cent (dried substance).
CHARACTERS
Appearance: White or almost white, crystalline powder.
Solubility: Practically insoluble in water, very soluble in methylene chloride, slightly soluble in ethanol (96 per cent).
IDENTIFICATION
A. Melting point: 79C to 82C.
B. Infrared absorption spectrophotometry.
TESTS
Solution S: To 5.0 g, add 25 mL of distilled water and heat at 50C for 10 min. Cool and dilute to 50.0 mL with distilled water. Filter. Use the filtrate as solution S.
Appearance of solution: The solution is clear and not more intensely coloured than reference solution.
Dissolve 0.50 g in acetone and dilute to 10.0 mL with the same solvent.
Acidity: Dissolve 1.0 g in 50 mL of ethanol (96 per cent) previously neutralised using 0.2 mL of phenolphthalein solution. Not more than 0.2 mL of 0.1 M sodium hydroxide is required to change the colour of the indicator to pink.
Related substances: To pass the test by liquid chromatography.
Halides expressed as chlorides: Maximum 100 ppm.
Sulfates: Maximum 100 ppm, determined on solution S.
Loss on drying: Maximum 0.5 per cent, determined on 1.000 g by drying in vacuo at 60C.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
The Uses of Fenofibrate:
Fenofibrate is an oral medication used to treat abnormal blood lipid levels.The MSDS-SDS Hazard Statement of Fenofibrate:
Fenofibrate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 03-Nov-24
Section 1: Chemical Product and Company Identification
Product Name & Other Names: Fenofibrate.
CAS Number: 49562-28-9
EINECS EC Code: 256-376-3
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
Section 2: Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Hazard Class and Category Code(s), Regulation (EC) No 1272/2008 (CLP)
Not a hazardous substance or mixture according to Regulation (EC) No. 1272/2008.
This substance is not classified as dangerous according to Directive 67/548/EEC.
Labeling Regulation EC 1272/2008 (CLP) & GHS
GHS Label Elements NONE |
Signal Word: None
Precautionary statements:
P261: Avoid breathing dust/fume/gas/mist/vapors/spray.
P262: Do not get in eyes, on skin, or on clothing.
P281: Use personal protective equipment as required.
P302+P352: IF ON SKIN: Wash with plenty of soap and water.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P337+313: If eye irritation persists get medical advice/attention.
Section 3: Composition and Information on Ingredients
Product Name & Other Names: Fenofibrate.
CAS Number: 49562-28-9
EINECS EC Code: 256-376-3
Section 4: First Aid Measures
Always seek medical advice after the first aid treatment.
Skin: Rinse with water. Soap may be used. Seek Medical Aid.
Eyes: Wash eyes with plenty of water for at least 15 minutes, lifting lids occasionally. Seek Medical Aid.
Inhalation: Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Ingestion: If swallowed, induce vomiting immediately after giving two glasses of water. Never give anything by mouth to an unconscious person.
Section 5: Fire and Explosion Data
Flammability of the Product: Not flammable. It may burn at high temperature.
Products of Combustion: Carbon oxides, chlorine compounds and fumes.
Fire Fighting Media and Instructions: Use water spray, alcohol-resistant foam, dry chemical, or carbon dioxide. Use extinguishing measures that are appropriate to local circumstances and the surrounding environment. Avoid solid water jet. Wear self-contained breathing apparatus for firefighting if necessary.
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 the suitable fire-extinguishing method according to the surrounding situation is used. Uninvolved persons should evacuate to a safe place.
Section 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: Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose of according to legal requirements.
Large Spill: Contain spilled material. Do not inhale vapors, mist, or gas. Avoid dust mist formation. Cover with inert absorbent material. Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water on the contaminated surface and dispose as per law.
Section 7: Handling and Storage
Precautions for safe handling: Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Wash thoroughly after handling. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust mist 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 cold, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Do not leave the material container open. 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 oxidizing agents. Storage: Room Temperature. Recommended in a cool and dark place, <15C.
Section 8: Exposure Controls/Personal Protection
Exposure Guidelines: This product, as supplied, does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Engineering Controls: Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume, or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.
Engineering Controls: Showers, Eyewash stations and Ventilation systems
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. 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.
Section 9: Physical and Chemical Properties
Physical state and appearance: White or almost white, crystalline powder.
Odor: No data found.
Odor threshold: No data found.
pH (5% soln/water): No data found.
Relative density: 1.18 predicted.
Melting point/freezing point: 79C –82C.
Initial boiling point and boiling range: 470C predicted.
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: Practically insoluble in water. Soluble in acetone, ether, benzene, chloroform.
Viscosity: No data found.
Section 10: Stability and Reactivity Data
Stability: It is stable in room temperature in closed containers under normal storage & handling.
Conditions of instability: Incompatible materials.
Products of combustion: Carbon oxides, chlorine compounds and fumes.
Incompatibility with various substances: Avoid high temperatures, sparks, open flames. Avoid contact with strong oxidizing agents.
Polymerization: Will not occur.
Section 11: Toxicological Information
LD50 Oral Rat: >2000 mg/kg.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: No data found.
Developmental Toxicity: No data found.
Reproductive Effects: No data found.
Section 12: Ecological Information
Toxicity to fish: LC50 - Pimephales promelas (fathead minnow) - 169 g/l - 28 d
Persistence and Degradability: No data found.
Mobility: No data found.
Results of PBT and vPvB assessment: No data available for assessment.
Section 13: Disposal Considerations
Waste Disposal: Waste must be disposed of in accordance with federal, state, and local environmental control regulations.
Section 14: Transport Information
DOT USA, TDG Canada & ADR/RID Europe: Not regulated.
IMDG/IMO: Not regulated.
IATA/ICAO: Not regulated.
Section 15: Other Regulatory Information
USA Regulations:
California Prop 65: None of the chemicals in this product are listed.
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.
Fenofibrate Structure
CAS Number 49562-28-9, Fenofibrate 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. 18-nov-24
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