OEL Fastrac Catalog

Please note, this OEL/ADE monograph also applies to arginine hydrochloride (CAS RN 1119-34-2), arginine glutamate (CAS RN 4320-30-3), and arginine asparate (CAS RN 7675-83-4). Arginine is an essential, to semi-essential, amino acid required for protein synthesis. It is used in diagnostic procedures, as a nutritional supplement and to treat a wide variety other medical conditions with varying degrees of effectiveness. Arginine is an amino acid building block in protein synthesis. Arginine induces a rise in plasma level of human growth hormone in subjects with intact pituitary function. Arginine boosts production of nitric oxide, relaxing blood vessels and treating angina and other cardiovascular problems. It is also an important intermediate in the urea cycle and in detoxifying nitrogenous wastes.

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 Arginine, just click the ADD TO CART button.

HBEL

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