OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to Sodium butyrate (CAS RN 156-54-7). Butyric acid is a saturated short-chain fatty acid (SCFA) with a 4-carbon backbone. Butyric acid is commonly found in esterified form in animal fats and plant oils. It has a role as a Mycoplasma genitalium metabolite and a human urinary metabolite. It is a straight chain saturated fatty acid and a fatty acid. It is a conjugate acid of a butyrate. Sodium butyrate is the sodium salt of butyrate with potential antineoplastic activity, Butyric acid is increasingly used as a supportive agent in the treatment and prevention of exacerbations of various diseases and disorders of the digestive tract, such as diarrhea (specific and nonspecific), inflammatory conditions (nonspecific bowel inflammation, diverticulitis, diversion colitis, radiation-induced bowel inflammation), functional disturbances (irritable bowel syndrome), dysbiosis, and postsurgery (resections, short bowel syndrome) or postchemotherapy conditions. Recently, it has been stressed that SCFA affect not only processes occurring in the lumen of the gastrointestinal tract but also other systems and organs, such as circulatory or nervous systems, through mechanisms associated with the intestinal barrier, carbohydrate metabolism, immunomodulation, and appetite control, and with an effect on obesity.

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 Butyric Acid, just click the ADD TO CART button.

HBEL

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