Clofibrate API Manufacturer in India

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Clofibrate API

Clofibrate is a lipid-regulating active pharmaceutical ingredient belonging to the fibrate class of compounds. It is chemically classified as an ethyl ester of a chlorophenoxyisobutyric acid derivative and has historically been used as a lipid-lowering agent.

Clofibrate is chemically known as Ethyl 2-(4-chlorophenoxy)-2-methylpropionate. It has the molecular formula C₁₂H₁₅ClO₃, molecular weight 242.70 g/mol, and CAS number 637-07-0.

Pharmaceutical Applications

Clofibrate belongs to the fibrate group of lipid-regulating compounds and has been associated with the management of elevated blood lipid levels. It acts through modulation of lipid metabolism and has historically been used to reduce circulating lipid concentrations.

Clofibrate is particularly relevant to pharmaceutical and analytical applications where a defined fibrate active ingredient or reference material is required.

Key Product Features

  • Fibrate-class API
  • Lipid-regulating pharmaceutical ingredient
  • Synthetic organic compound
  • Defined chemical identity
  • Suitable for pharmaceutical and analytical applications
  • Available as a pharmaceutical-grade active ingredient subject to applicable specifications

Pharmacological Class

Clofibrate is a fibric acid derivative and belongs to the fibrate class of lipid-regulating compounds.

Fibrates influence lipid metabolism through activation of PPAR-α, resulting in changes in the expression of genes involved in fatty-acid oxidation and lipoprotein metabolism.

Chemical and Physical Characteristics

Clofibrate is a low-molecular-weight organic ester containing chlorine and oxygen functional groups.

Chemical Identity

Product Name: Clofibrate

Chemical Name: Ethyl 2-(4-chlorophenoxy)-2-methylpropionate

CAS Number: 637-07-0

Molecular Formula: C₁₂H₁₅ClO₃

Molecular Weight: 242.70 g/mol

Physical Form: Liquid

Appearance: Colourless to pale-yellow liquid

Boiling Point: 158–160°C at 25 mm Hg

Density: 1.138–1.144 at 25°C

Melting Point: Approximately 118–119°C is reported in chemical databases; however, because Clofibrate is described as a liquid at ordinary temperature, the value should not be used as a routine API specification without reference to the applicable monograph.

NIST confirms the molecular formula, molecular weight and CAS number, while IARC describes the pure substance as a colourless to pale-yellow liquid.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR absorption conforms to Clofibrate reference standard
Assay (HPLC) 97.0% – 103.0% on anhydrous basis
Loss on Drying NMT 0.1%
pH (1% Solution) 2.0 – 4.0
Individual Impurity ≤ 0.5%
Water Content NMT 0.5%
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