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Fenofibrate USP EP IP BP Ph Eur Grade Supplier Exporter Manufacturers' Representative |
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Fenofibrate
CAS Number: 49562-28-9
Molecular Formula: C20H21ClO4
Molecular Weight: 360.83
Fenofibrate
Fenofibrate is an oral medication used to treat abnormal blood lipid levels.
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.
Packaging and Storage: Preserve in well-closed, light-resistant containers. Store at room temperature.
Fenofibrate is also available as per EP BP Ph Eur monograph.
Please visit SDS Safety Data Sheet of Fenofibrate Suppliers.
American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
Suppliers and Manufacturers' Representative:
9910 Bent Oak Dr
Houston, TX 77040, USA
Call Toll Free: 1-855-55-AMMOL 1-855-552-6665
Email: info@ammol.org