OEL Fastrac Catalog

Diamine oxidase (EC 1.4.3.22), also called histaminase, amiloride-binding protein, and amiloride-sensitive amine oxidase, is a copper-dependent amino oxidase encoded in humans by the AOC1 gene located on chromosome 7 (7q34-36). Diamine oxidase is a homodimer and ubiquitous enzyme with a molecular mass in the range of 140 to 200 kDa. The enzyme diamine oxidase, formerly known as histaminase, is naturally present in various tissues, with notably high activity in the intestinal mucosa. More precisely, diamine oxidase is abundantly found in the intestinal mucosa of humans and various other mammalian species. Diamine oxidase functions both as an endogenous enzyme within the body and as a frequently used nutritional supplement for addressing symptoms related to histamine intolerance (HIT). Diamine oxidase is frequently used as a nutritional supplement to treat disorders from histamine accumulation including migraines, fibromyalgia, bowel syndrome (IBS), atopic skin, or even attention deficit hyperactivity disorder (ADHD).

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 Diamine Oxidase, just click the ADD TO CART button.

HBEL

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