Specifications, Uses, SDS of Fenofibrate EP IP BP USP Manufacturers

	King of Chemicals Manufacturers
Specifications, Properties, Uses, SDS of Fenofibrate EP IP BP Ph Eur USP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 49562-28-9.
King of Chemicals has several associated companies having accreditations like cGMP, GLP - FDA Approved Good Manufacturing Practice and Good Laboratory Practice of WHO standard, ISO-9001, ISO-14001, ISO/IEC 17025, ISO ISO-45000, HACCP, FSSC 220000, FSSAI, "REACH" Registered, Kosher & Halal Certified. e-CTD and DMF support can be made available if needed. We offer USP NF BP Ph Eur EP IP JP Analytical Reagent FCC Food Grade Chemicals & Nutraceuticals.

Muby Chem Pvt. Ltd. is a several decades old group of companies, engaged in manufacturing, supplying, distributing, wholesale supplies of Fenofibrate EP IP BP Ph Eur USP Grade for actual users, including retail or small pack supplies for research and development work.

We supply 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 at best prices. We and/or our associated units have all the facilities to supply as per cGMP standard observing good manufacturing practice and good laboratory practice. We can assure low microbial count and also offer a test certificate for the same. We maintain warehouses across USA, India, and UAE. Our group exports to USA, Canada, Mexico, Argentina, Brazil, Chile, Korea, Malaysia, Thailand, Indonesia, Europe, and several other parts of the world. We supply in wholesale container loads to small pack of few grams. Solid products may be specified for it size and shape as desired by the buyer.

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.

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 SDS, Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 25-Jan-25

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.

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.

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 as it can scatter the fire. 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.

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:
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.

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.).
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 inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents. Storage: Room Temperature.

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 low.
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.
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.

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.

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: No data found.
Developmental Toxicity: No data found.
Reproductive Effects: No data found.

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 found for assessment.

Waste Disposal: Waste must be disposed of in accordance with federal, state, and local environmental control regulations. Follow all the pollution control rules.

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

USA Regulations:
California Prop 65: Not listed to cause cancer or birth defects or reproductive harm.

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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Fenofibrate Manufacturers, Suppliers, Exporters, Wholesalers:

Plot No. 2900/46&47 + 2900/163to167, GIDC, Ankleshwar, Dist. Bharuch, India
India, USA, UAE
TEL: (Office) 91-22-23774610, 91-22-23723564

If I give you “My Word” Nobody can undo it.
If I sign an “Agreement” my Lawyer will undo it

Our products are for industrial and laboratory use only. The user must test the material before use. We are not dispensing chemists or druggist and do not offer over the counter type (OTC) products for medical use by individuals.

Specifications, Properties, Uses, SDS of Fenofibrate EP IP BP Ph Eur USP Grade Manufacturer Supplier Exporter Wholesale & Small Packs, CAS Number 49562-28-9.

Fenofibrate Manufacturers, Suppliers, Exporters, Wholesalers: