Icosapent API | Omega-3 Fatty Acid Pharmaceutical API Manufacturer in India

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Icosapent API

Icosapent is a highly purified omega-3 fatty acid derivative of eicosapentaenoic acid (EPA). It is a long-chain polyunsaturated fatty acid used in pharmaceutical applications related to lipid management and cardiovascular risk reduction.

Icosapent is commonly associated with icosapent ethyl, the ethyl ester of eicosapentaenoic acid, which is used as an active pharmaceutical ingredient in prescription medicines for selected patients with elevated triglyceride levels and cardiovascular risk.

Icosapent API Manufacturer in India

Icosapent-related pharmaceutical ingredients require controlled processing and purification to achieve the desired fatty-acid composition and purity. Quality control is particularly important because omega-3 fatty acids can be susceptible to oxidation.

Manufacturing and testing may focus on identity, fatty-acid purity, assay, oxidative degradation products, peroxide value, anisidine value, residual solvents, water and other process-related impurities.

Chemical Information

CAS Number: 86227-47-6*
Molecular Formula: C22H34O2*
Molecular Weight: 330.51 g/mol*
Chemical Name: Icosapent Ethyl*
Common Name: EPA Ethyl Ester*
Drug Class: Lipid-Modifying Agent
Pharmacological Class: Omega-3 Fatty Acid Derivative
Therapeutic Class: Lipid-Lowering Agent
Therapeutic Area: Cardiovascular / Metabolic

*The term “Icosapent” can refer to EPA itself, while pharmaceutical product/API listings commonly use Icosapent Ethyl. The chemical data above correspond to Icosapent Ethyl and should be used only if that is the actual product being listed in your CMS.

Mechanism of Action

Icosapent Ethyl provides highly purified EPA. Its lipid-modifying effects are associated with changes in hepatic lipid metabolism and reduced production and secretion of triglyceride-rich lipoproteins.

EPA also has biological effects involving lipid oxidation, inflammatory signaling and lipoprotein metabolism. The precise mechanisms contributing to cardiovascular risk reduction are complex and are not completely explained by triglyceride lowering alone.

Pharmaceutical Applications

Icosapent Ethyl is used in approved pharmaceutical formulations for selected patients with:

  • Elevated triglyceride levels
  • Hypertriglyceridemia
  • Increased cardiovascular risk in appropriate clinical populations

The exact indication depends on the approved product labeling and regulatory jurisdiction.

Icosapent in Cardiovascular Research

Icosapent is particularly important in pharmaceutical research involving omega-3 fatty acids, triglyceride metabolism, lipoprotein biology and cardiovascular risk reduction.

Highly purified EPA differs from mixed omega-3 preparations because it provides a defined EPA-based active ingredient rather than a broad mixture of different fatty acids.

Physical and Chemical Properties

Icosapent Ethyl is an ethyl ester of eicosapentaenoic acid containing five carbon-carbon double bonds. It is a lipid-like substance that is sensitive to oxidation.

Appropriate protection from oxygen, heat and light is therefore important during manufacturing, packaging and storage.

Quality and Analytical Testing

Icosapent Ethyl API quality evaluation may include:

  • Identification by chromatographic methods
  • Fatty-acid profile
  • EPA ethyl ester assay
  • Related fatty-acid esters
  • Peroxide value
  • Anisidine value
  • Total oxidation value
  • Free fatty acids
  • Water content
  • Residual solvents
  • Elemental impurities
  • Heavy metals
  • Oxidative stability

Storage

Icosapent Ethyl should be stored in tightly closed, oxygen-protected packaging under controlled conditions. Protection from excessive heat, moisture, light and oxygen is important because polyunsaturated fatty-acid derivatives can undergo oxidative degradation.

Pharmaceutical Research and Development

Icosapent is relevant to research involving omega-3 fatty acid pharmacology, triglyceride reduction, lipid metabolism, cardiovascular therapeutics and EPA-based pharmaceutical formulations.

Icosapent API Summary

Icosapent, particularly in its pharmaceutical form Icosapent Ethyl, is an EPA-derived omega-3 fatty-acid pharmaceutical ingredient. Icosapent Ethyl has the molecular formula C22H34O2 and molecular weight 330.51 g/mol and is used in approved lipid-management therapies for selected patients with elevated triglycerides and cardiovascular risk.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 2.0%
Residue on Ignition NMT 0.5%
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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