OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Vitamin K2 (menaquinone-4) (CAS RN 863-61-6). Menaquinone-7 (MK-7) (CAS 2124-57-4) and menaquinone-4 (MK-4) (CAS 863-61-6), also known as menatetrenone, are forms of vitamin K2. Vitamin K represents a family of fatsoluble compounds with the common chemical structure of 3-substituted 2-methyl-1,4- napthoquinone. It naturally occurs in food as phylloquinone (vitamin K1) and menaquinones (vitamin K2). Menaquinones are a group of compounds with an unsaturated sidechain from 4 to 13 isoprenyl units (vitamin K2 or MK-n) and are found mainly in animal products such as meat, cheese and eggs (2, 6). The number of these units is given as a suffix(-n), they are named MK-4 to MK-13. It should be also pointed out that there can be differences between natural and synthetic vitamin K2, as was demonstrated in the case of MK-7, for which the synthetic mono-cis form (2Z) was inactive or had little activity compared with the natural all- E form.

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 Vitamin K2, just click the ADD TO CART button.

HBEL

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