OEL Fastrac Catalog

Biotin is a water-soluble, enzyme co-factor present in minute amounts in every living cell. Biotin is a vitamin, a coenzyme and a growth factor used for many different functions including hair loss, nerve disorders, vitamin deficiency, brittle nails, cancer, diabetes, and enzyme disorders. Biotin is a water-soluble member of the vitamin B group and was first isolated from egg yolk as an enzymatic yeast-growth factor. It is identical to coenzyme R (Rhizobium growth factor) and pharmacologically it is considered to be a carbonic acid-fixation coenzyme. Biotin affects gene expression by reacting with and binding covalently to histones in the nuclei of cells. The vitamin regulates synthesis of the enzyme that phosphorylates sugar, the actions of which are highly specific to glucose. Biotin also may be highly involved in glucose metabolism and biotin deficiency appears probable in patients on chronic hemodialysis. Biotin concentration influences lipid metabolism in humans. The vitamin has demonstrated inhibition of freeradical generation.

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 Biotin, just click the ADD TO CART button.

HBEL

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