OEL Fastrac Catalog

Carglumic acid is a synthetic analog of N-acetylglutamate (NAG), which is an essential allosteric activator of the liver enzyme carbamoyl phosphate synthase 1 (CPS1). CPS1 is found in the mitochondria and is the first enzyme of the urea cycle, which converts ammonia into urea. NAGS enzyme is an important component of the urea cycle to prevent the buildup of neurotoxic ammonium in the blood. In the absence of NAGS, NAG is not produced and plasma levels of ammonia are elevated due to impaired function of the urea cycle. Carglumic acid acts as a replacement for NAG in NAGS deficiency patients by activating CPS1, thereby removing the block in the urea cycle and facilitating ammonia detoxification and urea production. However, it does not help to regulate the urea cycle.

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 Carglumic Acid, just click the ADD TO CART button.

HBEL

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