OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to alpha tocopherol (CAS RN 59-02-9), alpha tocopherol acetate (CAS RN 58-95-7), alpha tocopherol succinate (CAS RN 4345-03-3), tocopherol nicotinate (CAS RN 43119-47-7), tocopherol calcium succinate (CAS RN 14464-85-8), tocopherol d-alpha (CAS RN 59-02-9), tocopherol dl-alpha (CAS RN 10191-41-0), and dl-alpha acetate (CAS RN 7695-91-2). Tocopherol acetate also known as vitamin E and is indicated for the treatment of vitamin E deficiency along with many non-labeled conditions. Tocopherol acetate, or vitamin E, is a fat-soluble vitamin which prevents the oxidation of polyunsaturated fatty acids. It reacts with free radicals, which are the cause of oxidative damage to cell membranes, without the formation of another free radical in the process. Alpha tocopherol is a natural component in the diet, is in over-the-counter supplements, and is in prescription multivitamins for prevention of vitamin E deficiency in adults and children over 11 receiving parenteral nutrition.

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.

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 Tocopherol, just click the ADD TO CART button.

HBEL

If you're wondering about HBEL, we have something for you.