Omega 3 fatty acid ethyl ester - Italian Market
Omega-3-acid ethyl esters as an Active Pharmaceutical Ingredient (API), specified for the Italian Market
Omega-3-acid ethyl esters is a light-yellow liquid comprised of a minimum of 40 per cent eicosapentaenoic acid (EPA) and a minimum of 34 per cent docosahexaenoic acid (DHA) (Ph. Eur. 1250 current ed.). The content of EPA and DHA ethyl esters is a minimum of 85 per cent and the content of total omega-3-acid ethyl esters is a minimum of 90 per cent. Tocopherol is added as an antioxidant. The product is a highly concentrated, unsaturated oil. It oxidizes readily in contact with air and is, therefore, filled in drums purged with nitrogen. It is well suited for use in soft gelatin capsules as the sole fill material.
Benefits
- This API complies with the European pharmacopoeia (Ph Eur.)
- The product is documented in a CEP
- Approved in Italy for use in pharmaceutical preparations
- Long history of use in Omacor®/Lovaza™, the first FDA- and EU-approved omega-3-based prescription drugs
- Our sustainable sourcing and production contribute to reduction of our customers carbon footprint
- The combination of technology and our know-how ensures an efficient production with a high utilization of the raw material
Technical Overview
Compendial Name
Omega-3-acid ethyl esters 90 (Ph.Eur.), Omega-3-Acid Ethyl Esters (USP)Region of Manufacture
NorwayPackage Size
- 190KG Steel drums
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