Fenofibrate EP IP USP BP Ph Eur Grade Manufacturers, with SDS GHS MSDS Sheet

Supplier, Manufacturer, Exporter of Fenofibrate EP IP USP BP Ph Eur Grade, 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.

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Fenofibrate CAS Number 49562-28-9, EINECS EC Number: 256-376-3, Molecular Formula: C20H21ClO4, Molecular Weight: 360.83, HS Code 29189900 or 29329990

Specifications, Safety Data Sheet, Manufacturing process details, Wholesale retail buy sell prices, Uses etc available on line in these pages for Fenofibrate.

General Properties and Specifications of Fenofibrate:
Appearance: White or almost white, crystalline powder.
Assay: >98%
Relative Density: 1.18 predicted.
Melting Point: 79C –82C.
Boiling Point: 470C predicted.
Solubility: Practically insoluble in water. Soluble in acetone, ether, benzene, chloroform.
Storage: Room Temperature. Recommended in a cool and dark place, <15C.

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.

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.
Packaging and Storage: Preserve in well-closed, light-resistant containers. Store at room temperature.

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.
Storage: 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.

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Fenofibrate SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 31-Aug-24

Product Name & Other Names: Fenofibrate.
CAS Number: 49562-28-9
EINECS EC Code: 256-376-3
Molecular Formula: C20H21ClO4
Molecular Weight: 360.83
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.

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.

Hazards not otherwise classified (HNOC):
May causes mild skin irritation.
May causes mild eye irritation.

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.

Product Name & Other Names: Fenofibrate.
CAS Number: 49562-28-9
EINECS EC Code: 256-376-3

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.

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.

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.

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.

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. 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.

Physical state and appearance: White or almost white, crystalline powder.
Odor: Not available.
Odor threshold: Not available.
pH (5% soln/water): Not available.
Relative density: 1.18 predicted.
Melting point/freezing point: 79C –82C.
Initial boiling point and boiling range: 470C predicted.
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: Practically insoluble in water. Soluble in acetone, ether, benzene, chloroform.
Viscosity: Not available.
Molecular Formula: C20H21ClO4
Molecular Weight: 360.83

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.

LD50 Oral Rat: >2000 mg/kg.
Carcinogenic Effects: Not a reported carcinogen by IARC, NTP, ACGIH, OSHA.
Mutagenic Effects: Not available.
Developmental Toxicity: Not available.
Reproductive Effects: No information available.

Toxicity to fish: LC50 - Pimephales promelas (fathead minnow) - 169 g/l - 28 d
Persistence and Degradability: Not available.
Mobility: Not available.
Results of PBT and vPvB assessment: No data available for assessment.

Waste Disposal: Waste must be disposed of in accordance with federal, state, and local environmental control regulations.

DOT USA, TDG Canada & ADR/RID Europe: Not dangerous goods.
IMDG/IMO: Not dangerous goods.
IATA/ICAO: Not dangerous goods.

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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