OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to mecobalamin (CAS RN 13422-55-4), hydroxocobalamine (CAS RN 13422-51-0), hydroxocobalamine acetate (CAS RN 22465-48-1), and adenosylcobalamine/cobamamide (CAS RN 13870-90-1). Vitamin B12, or cobalamin, is a cobalt-containing compound and exists in four forms; methylcobalamin (MeCbl), adenosylcobalamin (AdCbl), cyanocobalamin (CNCbl) and hydroxocobalamin (OHCbl). Three naturally occurring forms of vitamin B12, MeCbl, AdCbl, and OHCbl, are commercially available and have all been shown in clinical studies to improve vitamin B12 status. They are bioidentical to the B12 forms occurring in human physiology and animal foods. In contrast, CNCbl, a synthetic B12 compound used for food fortification and in some supplements, occurs only in trace amounts in human tissues as a result of cyanide intake from smoking or other sources.

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 B12, just click the ADD TO CART button.

HBEL

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