K85EE - CEP-accepting Markets
Omega-3-acid ethyl esters (K85EE) as an Active Pharmaceutical Ingredient (API), specified for CEP-accepting Markets
Omega-3-acid ethyl esters (K85EE) is a light-yellow liquid comprised of 430-495 mg/g eicosapentaenoic acid (EPA) and 347-403 mg/g docosahexaenoic acid (DHA). The content of EPA and DHA ethyl esters is 800-880 mg/g and the content of total omega-3-acid ethyl esters is a minimum of 90 per cent. Tocopherol is added as an antioxidant. K85EE 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.).
- K85EE is documented in a CEP
- K85EE is used as an active ingredient in finished drug products according to a documented and approved indication after approval by the concerned medicinal authority. The exact indication may be different in different markets
- Long history of use in the finished drug product Omacor®/Lovaza™, the first FDA- and EU-approved omega-3-based prescription drug
- 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
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Technical Overview
Compendial Name
Omega-3-acid ethyl esters 90 (Ph.Eur.), Omega-3-Acid Ethyl Esters (USP)Region of Manufacture
NorwayPackage Size
- 0,11KG Aluminium bottle
- 190KG Steel drums
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