OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to (all-cis)- 5,8,11,14,17- Eicosapentaenoic acid (CAS RN 10417-94-4), Docosahexaenoic acid (CAS RN 6217-54-5/ 25167- 62-8), Alpha-linolenic acid (CAS RN 463-40-1), Omega 3 fatty acid (mixture of EPA and DHA) (CAS RN 308064-99-5). Omega-3 fatty acids preparations are available as capsules, tablets, oral liquid, and as an injectable emulsion. Omega-3 (or n-3) fatty acids are long-chain (LC) polyunsaturated fatty acids (PUFAs) containing 18 to 22 carbon atoms (C18-C22) and a varying number of double bonds, the first of which is in the n-3 position. They are essential fatty acids and must be obtained from the diet. They have an important role as eicosanoid precursors and as components of cell membrane. Currently, the 3 most clinically relevant omega-3 PUFAs are ALA, EPA, and DHA and are derived from marine fish. Purified omega-3 fatty acid preparations and fish oils are used in patients with severe hypertriglyceridemia and for secondary prevention after myocardial infarction. They are marketed as dietary supplements and are also used in preparations for parenteral nutrition. Omega-3 fatty acids preparations are available as capsules, tablets, oral liquid, and as an injectable emulsion.

Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value and the Permitted Daily Exposure (PDE) value.

Why do you need this OEL Fastrac monograph?

OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:

• The numerical OEL and control band assignment needed to determine the level of required engineering controls and personal protective equipment
• A listing of all cited references utilized in the derivation of the OEL and ADE
• An expert review and discussion with respect to the critical endpoints of concern, the rationale for the choice of endpoints, and dose that is to be used in the derivation of the ADE (PDE), as required by the EMA's Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

Benefits of OEL Fastrac monographs

• Fully documented. Over 20 pages in length, with calculations and cited references.
• Save time! Unsurpassed delivery with instant download.
• Save money. Similar documents cost 5-12 times as much.
• Stay current. Automatic notification of revisions.

How to order

To order an OEL/ADE monograph for Omega-3 Fatty Acids, just click the ADD TO CART button.

HBEL

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