Fenofibrate EP IP BP Ph Eur USP Grade Manufacturers

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Fenofibrate EP IP BP Ph Eur USP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Fenofibrate and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.

We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.

Synonyms: Fenofibrate
CAS Number: 49562-28-9, Molecular Weight: 360.83, Chemical Formula: C20H21ClO4, EINECS EC Number: 256-376-3, FEMA: ----,

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.

Keywords: Fenofibrate IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 49562-28-9 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.

ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA

Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.

Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.

All products are Sold for Industrial and Laboratory Use only. No other use is permitted.